Identity
- Trade Name
- Revolution FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- Revolution Eagle designated medical device FDA UDI
- Model / Reference
- Eagle FDA UDI
- Description
- Revolution Eagle designated medical device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278403087 FDA UDI
- 510(k) Number
- K123596 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Full-body CT system
Revolution by Hangwei GE Medical Systems Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Full-body CT system.
- NAEOTOM Alpha.Prime — Siemens Healthcare · Class II
- SpotLight — Arineta , Ltd. · Class II
- TruPlan — Circle Cardiovascular Imaging Inc · Class IIa
- Osteo mat — Siemens Healthcare · Class II
- TOSHIBA SCANNER — Canon Medical Systems Corporation · Class II
- Bariatric table top — Siemens Healthcare · Class II
- table extension_P68 — Siemens Shanghai Medical Equipment Ltd. · Class II
- syngo. CT Pulmo 3D — Siemens Healthcare · Class II
Cleared under the same submission
K123596 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangwei GE Medical Systems Co., Ltd.
Sources (1)
- FDA UDI f81fb777-9544-4645-87e9-3160f2248634 34 fields · synced Jun 8, 2026