Mar 1.0
by GE Healthcare Japan Corporation
Mar 1.0 is a Class II device made by GE Healthcare Japan Corporation, cleared under FDA 510(k) K132410 on 17 Jan 2014 and listed in FDA GUDID since 25 Oct 2017 (UDI-DI 00840682134989), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840682134989 | Date25 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132410 | Date17 Jan 2014 | StatusActive |
Official records
- AccessGUDID record 00840682134989
- FDA 510(k) database K132410
Across registries
- FDA 510(k) K132410 decided 17 Jan 2014 Active
- FDA GUDID UDI-DI 00840682134989 listed 25 Oct 2017 Listed
Recalls
-
- Terminated Z-2581-2018
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
-
- Terminated Z-2184-2017
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
Timeline
- Cleared FDA 510(k) K132410
- Recall initiated FDA recalls Z-2184-2017
- Listed FDA GUDID 00840682134989
- Recall initiated FDA recalls Z-2581-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mar
- Generic name
- CT system application software
- Model / reference
- 1.0
- Primary DI / UDI-DI
- 00840682134989
- 510(k) Number
- FDA product code
- JAK
- GMDN term
- CT system application software
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution