# K151952: Synergy ODM

- Pathway: 510(k) (Special)
- Applicant: Topcon Medical Systems, Inc.
- Decided: Oct 1, 2015 after 78 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: 9 generations back to K896095 (1990). 17 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132667: Synergy Odm, Topcon Medical Systems, Inc. (2013) Summary page 4.

## Most influential descendants
- K182376: Harmony (2018), 4 descendants of its own
- K162039: OptosAdvance 4.0 Software (2017), 2 descendants of its own
- K232555: Harmony (2023), 1 descendant of its own
- K211715: RetinAI Discovery (2022), 1 descendant of its own
- K210396: Harmony Referral System (2021), 1 descendant of its own

## Indications for use
Synergy ODM is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

Source page: https://510kreport.com/device/K151952
Methodology: https://510kreport.com/methodology