# K210396: Harmony Referral System

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Healthcare Solutions EMEA Oy
- Decided: Sep 13, 2021 after 215 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K896095 (1990). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182376: Harmony, Topcon Medical Systems, Inc. (2018) Summary page 4.

## Most influential descendants
- K253893: Harmony Referral System with Harmony OCT Viewer (Octave) (2026), 0 descendants of its own

## Indications for use
Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any interpretations nor provides treatment recommendations.

Source page: https://510kreport.com/device/K210396
Methodology: https://510kreport.com/methodology