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Nm/Ct 850
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref H3907BC, H3907BD, H3907BH, H3907BJ, H3907BG, H3907BKModel NM/CT 850
Identity
- Trade Name
- NM/CT 850 EUDAMEDNMCT 850 FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- NM/CT 850 EUDAMEDNM_CT 850 NM Gantry Final MDR FDA UDI
- Model / Reference
- NM/CT 850 EUDAMEDH3907BC, H3907BD, H3907BH, H3907BJ, H3907BG, H3907BK EUDAMEDH3907BE, H3907BF FDA UDI
- Description
- NM_CT 850 NM Gantry Final MDR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00198953061336 EUDAMEDFDA UDI
- Basic UDI-DI
- 08406821BUG004697Q EUDAMED
- 510(k) Number
- K173816 FDA UDI
- FDA Product Code
- JAK FDA UDIKPS FDA UDI
- EMDN Code
- Z11020201 CT/GAMMA CAMERA SYSTEMS EUDAMED
- GMDN Term
- Full-body CT 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 850 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 | 08406821BUG004697Q | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 1bd218e7-263b-44d4-b71d-61d00637def6 61 fields · synced Aug 4, 2026
- FDA UDI 543a0136-b9c3-40a2-8dc5-a896c5d1bae9 34 fields · synced May 30, 2026
- EUDAMED 1bd218e7-263b-44d4-b71d-61d00637def6-1 61 fields · synced Jun 10, 2026