Optima CT680 Expert
by GE Hangwei Medical Systems Company Ltd.
Optima CT680 Expert (OptimaCT680Expert) is a Class II device made by GE Hangwei Medical Systems Company Ltd., cleared under FDA 510(k) K192686 on 24 Oct 2019 and listed in FDA GUDID since 4 Nov 2019 (UDI-DI 00840682146937), active as of 23 Oct 2026. 5 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
5 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840682146937 | Date4 Nov 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192686 | Date24 Oct 2019 | StatusActive |
Official records
- AccessGUDID record 00840682146937
- FDA 510(k) database K192686
Across registries
- FDA 510(k) K192686 decided 24 Oct 2019 Active
- FDA GUDID UDI-DI 00840682146937 listed 4 Nov 2019 Listed
Recalls
-
- Ongoing Z-0612-2025
- Ongoing Z-0603-2025
- Ongoing Z-0610-2025
- Ongoing Z-0606-2025
- Ongoing Z-0611-2025
GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
Timeline
- Cleared FDA 510(k) K192686
- Listed FDA GUDID 00840682146937
- Recall initiated FDA recalls Z-0612-2025
- Recall initiated FDA recalls Z-0603-2025
- Recall initiated FDA recalls Z-0610-2025
- Recall initiated FDA recalls Z-0606-2025
- Recall initiated FDA recalls Z-0611-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Optima
- Generic name
- Full-body CT system
- Model / Ref / Catalog
- CT680 Expert, OptimaCT680Expert
- Primary DI / UDI-DI
- 00840682146937
- 510(k) Number
- FDA product code
- JAK
- GMDN term
- Full-body CT system
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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