Codonics Horizon® Operating Software 3.0.2

by Codonics Inc.

Codonics Horizon® Operating Software 3.0.2 is a Class II device made by Codonics Inc., cleared under FDA 510(k) K021054 on 9 May 2002 and listed in FDA GUDID since 23 Aug 2016 (UDI-DI 00814905020052), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00814905020052 UDI-DI	Date23 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK021054	Date9 May 2002Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00814905020052
FDA 510(k) database 510(k) number K021054

Across registries

2 registries list this device

FDA 510(k) K021054 decided 9 May 2002 Active
FDA GUDID UDI-DI 00814905020052 listed 23 Aug 2016 Listed

Timeline

2 dated events

9 May 2002 Cleared FDA 510(k) K021054
23 Aug 2016 Listed FDA GUDID 00814905020052

Coverage

1 jurisdiction

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Withdrawn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: 3.0.2

Primary DI / UDI-DI: 00814905020052
510(k) Number: K021054
FDA product code: LMC
GMDN term: Diagnostic-imaging multiformat camera

Device class: Class II
Regulation number: 892.2040
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Serial number
Manufacturing date

Other properties (11, all answered No)