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Revolution CT ES with Apex edition
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref Revolution CT ES with Apex editionModel Apex Edition
Identity
- Trade Name
- Revolution CT ES with Apex edition EUDAMEDRevolution CT FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- Revolution CT ES with Apex edition - Designated System Medical Device FDA UDI
- Model / Reference
- Apex Edition EUDAMEDRevolution CT ES with Apex edition EUDAMEDES with Apex edition FDA UDI
- Description
- Revolution CT ES with Apex edition - Designated System Medical Device FDA UDI
Identifiers
- Catalog Number
- 5826588 FDA UDI
- Primary DI / UDI-DI
- 00195278471277 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00154H8 EUDAMED
- Direct Marketing DI
- 00195278471277 EUDAMED
- 510(k) Number
- K191777 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030607 COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE EUDAMED
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 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
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Revolution CT ES with Apex edition by GE Medical Systems, LLC — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K213715 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K191777 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00154H8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
- EUDAMED SRN
- US-MF-000018315
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED 65bfb726-f87e-47c7-b90a-47bae3136c0b 61 fields · synced Jul 27, 2026
- FDA UDI 3152e434-5f60-423b-9bc4-1899c26caf4e 35 fields · synced May 29, 2026
- FDA 510(k) K213715 1 fields · synced Jun 9, 2026