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Aurora
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref Aurora-NM-PCMModel Aurora510(k) K243605
Identity
- Trade Name
- Aurora EUDAMEDFDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- Aurora EUDAMEDAURORA NM GANTRY FINAL FDA UDI
- Model / Reference
- Aurora EUDAMEDAurora-NM-PCM EUDAMEDSPECT with Revolution Ascend CT FDA UDI
- Description
- AURORA NM GANTRY FINAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278878502 EUDAMEDFDA UDI
- Basic UDI-DI
- 08406821BUG004817E EUDAMED
- 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
- Denmark 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
Yes
FDA UDI
Aurora by GE Medical Systems Israel, Functional Imaging — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243605 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K251153 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 08406821BUG004817E | Class IIb | Active |
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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 741a4f4c-d47a-478d-b703-28a3af0260ae 85 fields · synced Jun 19, 2026
- FDA UDI a4aee6ec-a9ed-43ff-971c-79caace10d4b 33 fields · synced May 30, 2026
- FDA 510(k) K243605 1 fields · synced May 18, 2026