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Nm/Ct 860
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref H3908BF, H3908BG, H3908BK, H3908BL, H3908BM, H3908BN Model NM/CT 860
Identity
- Trade Name
- NM/CT 860 EUDAMEDNMCT 860 FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- NM/CT 860 EUDAMEDNM_CT 860 NM Gantry Final MDR FDA UDI
- Model / Reference
- NM/CT 860 EUDAMEDH3908BF, H3908BG, H3908BK, H3908BL, H3908BM, H3908BN EUDAMEDH3908BJ, H3908BH FDA UDI
- Description
- NM_CT 860 NM Gantry Final MDR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00198953061329 EUDAMEDFDA UDI
- Basic UDI-DI
- 08406821BUG004717B 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 860 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 | 08406821BUG004717B | 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 47f1fa67-58ba-4d23-9adf-aefa1e12d5ea 61 fields · synced Jun 18, 2026
- FDA UDI 6050b0ab-27f4-4fdd-a0d4-a04aba3c7480 34 fields · synced May 30, 2026
- EUDAMED 47f1fa67-58ba-4d23-9adf-aefa1e12d5ea-1 61 fields · synced Jun 9, 2026