Horizon A
by Hologic
Horizon A (Horizon-A) is a Class II device made by Hologic, cleared under FDA 510(k) K023398 on 8 Nov 2002 and listed in FDA GUDID since 23 Aug 2016 (UDI-DI 15420045505384), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number15420045505384 | Date23 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023398 | Date8 Nov 2002 | StatusActive |
Official records
- AccessGUDID record 15420045505384
- FDA 510(k) database K023398
Across registries
- FDA 510(k) K023398 decided 8 Nov 2002 Active
- FDA GUDID UDI-DI 15420045505384 listed 23 Aug 2016 Listed
Recalls
-
- Ongoing Z-2373-2024
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.
Timeline
- Cleared FDA 510(k) K023398
- Listed FDA GUDID 15420045505384
- Recall initiated FDA recalls Z-2373-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Bone absorptiometric x-ray system, dual-energy
- Model / Ref / Catalog
- Horizon A, Horizon-A
- Primary DI / UDI-DI
- 15420045505384
- 510(k) Number
- FDA product code
- KGI
- GMDN term
- Bone absorptiometric x-ray system, dual-energy
- Device class
- Class II
- Regulation number
- 892.1170
- GUDID distribution status
- In Commercial Distribution
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