# K093313: Synergy

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Systems, Inc.
- Decided: Dec 2, 2009 after 41 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: 6 generations back to K896095 (1990). 13 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082364: Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for, Topcon Corp. (2008) Summary page 2.
- K013694: Nidek Advanced Vision Information System (Navis), Nidek, Inc. (2002) Summary page 2.
- K071299: IP System, Oculab IP, Optomize IP, Retasure IP, Digital Healthcare, Ltd. (2007) Summary page 2.
- K072971: Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal Thickness, Topcon Medical Systems, Inc. (2009) Summary page 2.

## Most influential descendants
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match (2012), 25 descendants of its own
- K132667: Synergy Odm (2013), 9 descendants of its own
- K151952: Synergy ODM (2015), 8 descendants of its own
- K182376: Harmony (2018), 4 descendants of its own
- K150467: Retina Workplace (2015), 3 descendants of its own

## Indications for use
Synergy is a comprehensive software platform intended for use in acquisition or 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/K093313
Methodology: https://510kreport.com/methodology