← Back to catalogue
Nm/Ct 870 Dr
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref H3906FZ, H3906GA, H3906GB, H3906GC, H3906GD, H3906GEModel NM/CT 870 DR
Identity
- Trade Name
- NM/CT 870 DR EUDAMEDNMCT FDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Device Name
- NM/CT 870 DR EUDAMED870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE FDA UDI
- Model / Reference
- NM/CT 870 DR EUDAMEDH3906FZ, H3906GA, H3906GB, H3906GC, H3906GD, H3906GE EUDAMED870 DR FDA UDI
- Description
- 870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278788269 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00401H2 EUDAMED
- 510(k) Number
- K093514 FDA UDI
- FDA Product Code
- JAK FDA UDIKPS FDA UDI
- EMDN Code
- Z11020201 CT/GAMMA CAMERA SYSTEMS EUDAMED
- GMDN Term
- Stationary gamma camera system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI892.1200 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
EUDAMED
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
Yes
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
Nm/Ct 870 Dr by GE Medical Systems Israel, Functional Imaging — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00401H2 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
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 3b94c068-754a-4d3b-96b7-8fb0deb22a6e 61 fields · synced Jun 19, 2026
- FDA UDI bf4dd765-da92-484f-8ef4-42b3ee878e41 34 fields · synced May 29, 2026
- EUDAMED 3b94c068-754a-4d3b-96b7-8fb0deb22a6e-1 61 fields · synced Jun 10, 2026