Identity
- Trade Name
- MEGreview™ FDA UDI
- Generic Name
- Magnetoencephalography system, superconducting FDA UDI
- Device Name
- MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be used for localization of eloquent cortex, such as visual, auditory, somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with other imaging modalities can contribute to presurgical evaluation. MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography. FDA UDI
- Model / Reference
- SW26241N FDA UDI
- Description
- MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be used for localization of eloquent cortex, such as visual, auditory, somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with other imaging modalities can contribute to presurgical evaluation. MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430056480404 FDA UDI
- 510(k) Number
- K233985 FDA UDI
- FDA Product Code
- OLY FDA UDIOLX FDA UDI
- GMDN Term
- Magnetoencephalography system, superconducting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Magnetoencephalography system, superconducting
MEGreview™ by Megin Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Magnetoencephalography system, superconducting.
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- TRIUX™ neo — Megin Oy · Class II
Cleared under the same submission
K233985 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Megin Oy
Sources (1)
- FDA UDI b4069f99-dc06-48e3-8f7d-d8772581a489 34 fields · synced May 31, 2026