Identity
- Trade Name
- MyoSPECT FDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Device Name
- MyoSPECT GANTRY FDA UDI
- Model / Reference
- H3912AA FDA UDI
- Description
- MyoSPECT GANTRY FDA UDI
Identifiers
- Catalog Number
- 5875815-10 FDA UDI
- Primary DI / UDI-DI
- 00195278421586 FDA UDI
- 510(k) Number
- K212004 FDA UDI
- FDA Product Code
- KPS FDA UDI
- GMDN Term
- Stationary gamma camera system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1200 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary gamma camera system
MyoSPECT by Ge Medical Systems Israel , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212004 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
- Ge Medical Systems Israel , Ltd.
Sources (1)
- FDA UDI 3ca6fed7-5066-486d-89d0-95f845f3fb3b 35 fields · synced Jun 8, 2026