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Harmony 5.09

by Topcon Healthcare, Inc.

Harmony 5.09 is a Class II device made by Topcon Healthcare, Inc., cleared under FDA 510(k) K182376 on 28 Sep 2018 and listed in FDA GUDID since 4 Mar 2025 (UDI-DI 00850003069517), active as of 23 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 23 Oct 2026

Documents

510(k) K182376

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 Number00850003069517 UDI-DI Date4 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK182376 Date28 Sep 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182376 decided 28 Sep 2018 Active
  • FDA GUDID UDI-DI 00850003069517 listed 4 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182376
  2. Listed FDA GUDID 00850003069517

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Harmony
Generic name
Camera application software
Model / reference
5.09
Primary DI / UDI-DI
00850003069517
510(k) Number
FDA product code
NFJ
GMDN term
Camera application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Camera application software

Cleared under the same submission (K182376)

and 8 more cleared under K182376

Similar devices

Other devices filed under FDA product code NFJ (System, Image Management, Ophthalmic).

Other devices from Topcon Healthcare, Inc.

See all devices from Topcon Healthcare, Inc. →

Properties

Other properties (15, all answered No)