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Horizon C

by Hologic

Horizon C (Horizon-C) 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 15420045505698), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K023398

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15420045505698 UDI-DI Date23 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK023398 Date8 Nov 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K023398 decided 8 Nov 2002 Active
  • FDA GUDID UDI-DI 15420045505698 listed 23 Aug 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2373-2024 FDA Class II initiated 13 Jun 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

3 dated events

  1. Cleared FDA 510(k) K023398
  2. Listed FDA GUDID 15420045505698
  3. Recall initiated FDA recalls Z-2373-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Bone absorptiometric x-ray system, dual-energy
Model / Ref / Catalog
Horizon C, Horizon-C
Primary DI / UDI-DI
15420045505698
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

Related devices

Category: Bone absorptiometric x-ray system, dual-energy

Cleared under the same submission (K023398)

Similar devices

Other devices filed under FDA product code KGI (Densitometer, bone).

Other devices from Hologic

See all devices from Hologic →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)