Omni Legend
by GE Medical Systems Israel, Functional Imaging
Omni Legend is a Class II device made by GE Medical Systems Israel, Functional Imaging, cleared under FDA 510(k) K221932 on 2 Sep 2022 and listed in FDA GUDID since 12 Sep 2022 (UDI-DI 00195278592309), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00195278592309 | Date12 Sep 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221932 | Date2 Sep 2022 | StatusActive |
Official records
- AccessGUDID record 00195278592309
- FDA 510(k) database K221932
Across registries
- FDA 510(k) K221932 decided 2 Sep 2022 Active
- FDA GUDID UDI-DI 00195278592309 listed 12 Sep 2022 Listed
Recalls
-
- Completed Z-1112-2026
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
Timeline
- Cleared FDA 510(k) K221932
- Listed FDA GUDID 00195278592309
- Recall initiated FDA recalls Z-1112-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Omni
- Generic name
- Full-body CT system
- Model / reference
- Legend
- Primary DI / UDI-DI
- 00195278592309
- 510(k) Number
- FDA product code
- KPS, JAK
- GMDN term
- Full-body CT system
- Device class
- Class II
- Regulation number
- 892.1200, 892.1750
- GUDID distribution status
- In Commercial Distribution
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