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MyoSPECT ES to MyoSPECT Upgrade
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref H3912BSModel MyoSPECTRef H3912AA
Identity
- Trade Name
- MyoSPECT ES to MyoSPECT Upgrade EUDAMEDMyoSPECT EUDAMEDMyoSEPCT ES to MyoSPECT Upgrade FDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Device Name
- MyoSPECT EUDAMEDMyoSPECT ES to MyoSPECT Upgrade kit FDA UDI
- Model / Reference
- MyoSPECT EUDAMEDH3912BS EUDAMEDFDA UDIH3912AA EUDAMED
- Description
- MyoSPECT ES to MyoSPECT Upgrade kit FDA UDI
Identifiers
- Catalog Number
- 5941445 FDA UDI
- Primary DI / UDI-DI
- 00195278722546 EUDAMEDFDA UDID-IL-MF-000003062WY EUDAMED
- Basic UDI-DI
- 8406821BUG00251H7 EUDAMEDB-IL-MF-000003062WY EUDAMED
- 510(k) Number
- K212004 FDA UDI
- FDA Product Code
- KPS FDA UDI
- EMDN Code
- Z11020104 FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION EUDAMEDZ11020101 MOBILE GAMMA CAMERAS EUDAMED
- GMDN Term
- Stationary gamma camera system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMEDEUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
MyoSPECT ES to MyoSPECT Upgrade by GE Medical Systems Israel, Functional Imaging — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8406821BUG00251H7 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00251H7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Medical Systems Israel, Functional Imaging
- EUDAMED SRN
- IL-MF-000003062
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED e7c5df29-42d0-4843-9fe5-8ed3aa0e9893 61 fields · synced Aug 2, 2026
- EUDAMED 574bb537-7c0a-4cca-9b5c-d079e7d704ba 61 fields · synced May 17, 2026
- FDA UDI 70bbdb9f-d2fe-4739-afc9-056316168c76 35 fields · synced May 30, 2026