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Revolution Ascend Elite
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref Revolution Ascend EliteModel Revolution Ascend, Revolution Ascend Elite, Revolution Ascend Plus, Revolution Ascend Select
Identity
- Trade Name
- Revolution Ascend Elite EUDAMEDRevolution FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- Revolution Ascend EUDAMEDAscend Elite Gantry common top asm with UDI FDA UDI
- Model / Reference
- Revolution Ascend Elite EUDAMEDRevolution Ascend, Revolution Ascend Elite, Revolution Ascend Plus, Revolution Ascend Select EUDAMEDAscend Elite FDA UDI
- Description
- Ascend Elite Gantry common top asm with UDI FDA UDI
Identifiers
- Catalog Number
- RevolutionAscendElite FDA UDI
- Primary DI / UDI-DI
- 00195278718129 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 Elite by GE Healthcare Japan Corporation — 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 | 8406821BUG00117H2 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 (3)
- EUDAMED 6f040fd8-5a42-4e66-bca1-686de23c1a1b 61 fields · synced Jul 25, 2026
- FDA UDI c76ec879-f463-4b13-b1c9-c17b73d57028 35 fields · synced May 29, 2026
- EUDAMED c005bacb-b8a0-4a95-a4a1-68df8bce9d2e 61 fields · synced Jul 25, 2026