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Revolution Ascend Plus
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref Revolution Ascend Plus510(k) K203169Model Revolution Ascend, Revolution Ascend Elite, Revolution Ascend Plus, Revolution Ascend Select
Identity
- Trade Name
- Revolution Ascend Plus EUDAMEDRevolution FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- Revolution Ascend EUDAMEDAscend Plus Gantry common top asm with UDI FDA UDI
- Model / Reference
- Revolution Ascend Plus EUDAMEDRevolution Ascend, Revolution Ascend Elite, Revolution Ascend Plus, Revolution Ascend Select EUDAMEDAscend Plus FDA UDI
- Description
- Ascend Plus Gantry common top asm with UDI FDA UDI
Identifiers
- Catalog Number
- RevolutionAscendPlus FDA UDI
- Primary DI / UDI-DI
- 00195278718136 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00117H2 EUDAMED
- 510(k) Number
- K213938 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030605 COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS EUDAMEDZ11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS 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
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
Revolution Ascend Plus by GE Healthcare Japan Corporation — 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 | K203169 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K213938 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00117H2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GE Healthcare Japan Corporation
- EUDAMED SRN
- JP-MF-000009291
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (4)
- EUDAMED 6953ffc2-245b-4a34-9321-5e5a48f79ac4 85 fields · synced Jul 9, 2026
- FDA UDI 850d0407-28ad-4c37-b390-ec56ba5774e5 35 fields · synced May 30, 2026
- EUDAMED 5aec4334-b654-433e-9124-b8c4e902975a 61 fields · synced Jul 9, 2026
- FDA 510(k) K203169 1 fields · synced May 18, 2026