{
  "schemaVersion": "2.0.0",
  "identity": {
    "slug": "brainsway-deep-tms",
    "manufacturerSlug": "brainsway",
    "name": {
      "value": "Deep TMS System",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.brainsway.com/products/",
          "label": "BrainsWay — products page"
        },
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "modelNumber": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "codename": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "aliases": {
      "value": [
        "BrainsWay Deep TMS",
        "H-Coil TMS",
        "Deep Transcranial Magnetic Stimulation"
      ],
      "status": "verified",
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        {
          "url": "https://www.brainsway.com/products/",
          "label": "BrainsWay — products page"
        },
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "generation": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "predecessorSlug": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "successorSlug": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "tagline": {
      "status": "unknown",
      "sources": [
        {
          "label": "editorial"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "shortDescription": {
      "status": "unknown",
      "sources": [
        {
          "label": "editorial prose"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "longDescription": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "countryOfOrigin": {
      "value": "IL",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "releaseDate": {
      "value": "2013-01-07",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "announcedDate": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "discontinuedDate": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "status": {
      "value": "available",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.brainsway.com/products/",
          "label": "BrainsWay — products page"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
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      "value": "non-invasive",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "modalities": {
      "value": [
        "TMS"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "primaryModality": {
      "value": "TMS",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "direction": {
      "value": "write",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "category": {
      "value": [
        "therapeutic",
        "stimulation",
        "clinical-grade"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "formFactor": {
      "value": [
        "helmet",
        "mobile-cart"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.tandfonline.com/doi/full/10.1080/17434440.2021.2013803",
          "label": "Tendler et al. (2021) — Deep TMS H7 coil device profile"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "intendedUseCases": {
      "value": [
        "treatment of major depressive disorder",
        "treatment of obsessive-compulsive disorder (H7 coil)",
        "short-term smoking cessation in adults (H4 coil)",
        "treatment of MDD with anxious depression (H1 coil)"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        },
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170078.pdf",
          "label": "FDA De Novo DEN170078 — H7 coil for OCD",
          "date": "2018-08-17"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "targetUsers": {
      "value": [
        "psychiatrist",
        "clinician",
        "patient-depression"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "stimulation": {
    "capable": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "connectivity": {
    "protocols": {
      "status": "unknown",
      "sources": [
        {
          "label": "v0 said ethernet; not in primary sources I have"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "bluetoothVersion": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "bluetoothProfiles": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "concurrentMode": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "encryptionInTransit": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "pairingMethods": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "cloudSync": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "offlineRecording": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "power": {
    "sources": {
      "value": [
        "wired-mains"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "batteryLifeActiveHours": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "chargingPort": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "chargingTimeMinutes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "batteryReplaceable": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "value": "AC mains-powered cart-mounted system; capacitor bank discharged through the H-coil. Active cooling.",
      "status": "verified",
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        {
          "url": "https://www.tandfonline.com/doi/full/10.1080/17434440.2021.2013803",
          "label": "Tendler et al. (2021) — Deep TMS H7 coil device profile"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
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      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "dimensions": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "materials": {
      "value": [
        "copper",
        "polymer"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.tandfonline.com/doi/full/10.1080/17434440.2021.2013803",
          "label": "Tendler et al. (2021) — Deep TMS H7 coil device profile"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "sizes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "headCircumferenceCm": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "operatingTempC": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "compute": {
    "hasOnboardComputer": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "operatingSystems": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "primaryOs": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "edgeMlAccelerator": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "rootAccessLevel": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "appSandbox": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "thirdPartyAppsAllowed": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "software": {
    "apps": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "mobileApp": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "cloudPlatform": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "offlineMode": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "subscriptionRequired": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "rawDataAccess": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "exportFormats": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "lslSupport": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "dataOwnership": {
      "value": "manufacturer",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "privacyPolicyUrl": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "sdk": {
    "hasSdk": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "docsUrl": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "openSource": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "languages": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "webBluetooth": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "rawSampleAccess": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "bciParadigms": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "thirdPartyIntegrations": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "capabilities": {
    "attentionFocus": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "meditationCalm": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "neurofeedback": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "meditationCoaching": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "sleepTracking": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "customCapabilities": {
      "value": [
        {
          "name": "Deep cortical TMS via H-coil",
          "description": "Multi-loop H-coil produces broader and deeper magnetic fields than figure-8 coils, reaching ~3 cm into cortex.",
          "evidenceLevel": "fda-cleared"
        },
        {
          "name": "First non-invasive device cleared for OCD",
          "description": "H7 coil cleared via FDA De Novo (DEN170078) for OCD in August 2018.",
          "evidenceLevel": "fda-cleared"
        }
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/k122288.pdf",
          "label": "FDA K122288 510(k) summary (PDF)"
        },
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170078.pdf",
          "label": "FDA De Novo DEN170078 — H7 coil for OCD",
          "date": "2018-08-17"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "security": {
    "authenticationFactors": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "perUserProfiles": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "requiresAccount": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "claimingMethods": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "ownershipModel": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "activationLock": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "remoteLock": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "remoteWipe": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "findMyDevice": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "firmware": {
    "otaSupported": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "otaTransports": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "updateMechanism": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "updateChannels": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "rollbackSupported": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "signedUpdates": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "forcedUpdates": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "userDeferrable": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "updateRequiresAppCompanion": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "averageUpdateFrequency": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "regulatory": {
    "fdaStatus": {
      "value": "de-novo",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170078.pdf",
          "label": "FDA De Novo DEN170078 — H7 coil for OCD",
          "date": "2018-08-17"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "ceMark": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "certifications": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "prescriptionRequired": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288",
          "label": "FDA 510(k) K122288 — BrainsWay Deep TMS System (Brainsway Ltd., Kfar Saba, IL)",
          "date": "2013-01-07"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "pediatricApproved": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "pricing": {
    "msrp": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "currentPrice": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "subscription": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "buyUrls": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "warranty": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "returnPolicyDays": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "media": {
    "officialUrl": {
      "value": "https://www.brainsway.com",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.brainsway.com",
          "label": "BrainsWay — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "productPageUrl": {
      "value": "https://www.brainsway.com/products/",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.brainsway.com/products/",
          "label": "BrainsWay — products page"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "editorial": {
    "pros": [
      "Deeper cortical penetration than figure-8 TMS coils",
      "Multiple FDA-cleared indications (MDD, OCD, smoking cessation)",
      "Non-invasive — no surgery, no implant"
    ],
    "cons": [
      "In-clinic only; long course (typically 4–6 weeks daily)",
      "Capital equipment cost limits availability outside specialty clinics",
      "Open-loop — no real-time feedback from the brain"
    ],
    "bestFor": [],
    "notFor": [],
    "comparableDevices": [
      "neuronetics-neurostar"
    ]
  },
  "provenance": {
    "sources": [
      {
        "label": "BrainsWay — official site",
        "url": "https://www.brainsway.com"
      },
      {
        "label": "FDA 510(k) K122288 (H1 / MDD)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122288"
      },
      {
        "label": "FDA K122288 510(k) summary (PDF)",
        "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/k122288.pdf"
      },
      {
        "label": "FDA De Novo DEN170078 (H7 / OCD)",
        "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170078.pdf"
      },
      {
        "label": "Tendler et al. (2021) Deep TMS H7 coil",
        "url": "https://www.tandfonline.com/doi/full/10.1080/17434440.2021.2013803"
      }
    ],
    "lastReviewedAt": "2026-05-05"
  }
}