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Codonics Horizon® Operating Software 2.1.3

by Codonics Inc.

Codonics Horizon® Operating Software 2.1.3 is a Class II device made by Codonics Inc., cleared under FDA 510(k) K060440 on 16 Mar 2006 and listed in FDA GUDID since 23 Aug 2016 (UDI-DI 00814905020045), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K060440

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814905020045 UDI-DI Date23 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK060440 Date16 Mar 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060440 decided 16 Mar 2006 Active
  • FDA GUDID UDI-DI 00814905020045 listed 23 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K060440
  2. Listed FDA GUDID 00814905020045

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Codonics Horizon® Operating Software
Generic name
Diagnostic-imaging multiformat camera
Model / reference
2.1.3
Primary DI / UDI-DI
00814905020045
510(k) Number
FDA product code
LMC
GMDN term
Diagnostic-imaging multiformat camera
Device class
Class II
Regulation number
892.2040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Diagnostic-imaging multiformat camera

Other devices from Codonics Inc.

See all devices from Codonics Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)