# K082364: Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Corp.
- Decided: Sep 30, 2008 after 43 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: 5 generations back to K896095 (1990). 9 ancestors in all.
50 later devices descend from it; 6 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870039: Imagenet Digital Ophthalmic Imaging System, Par Microsystems Corp. (1987) Summary page 1.
- K013694: Nidek Advanced Vision Information System (Navis), Nidek, Inc. (2002) Summary page 2.

## Most influential descendants
- K093313: Synergy (2009), 29 descendants of its own
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match (2012), 25 descendants of its own
- K101861: Truevision 3D Visualization and Guidance System (2010), 13 descendants of its own
- K132667: Synergy Odm (2013), 9 descendants of its own
- K151952: Synergy ODM (2015), 8 descendants of its own

## Indications for use
The IMAGEnet Professional PC Software System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments or through computerized networks. The software system is indicated for use with retinal camera or digital camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slit lamps.

Source page: https://510kreport.com/device/K082364
Methodology: https://510kreport.com/methodology