# K173689: Ophthalmic Software Platform RX

- Pathway: 510(k) (Traditional)
- Applicant: Canon Inc. -Medical Equipment Group
- Decided: Feb 23, 2018 after 84 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: 1 generation back to K132438 (2013). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132438: Imagenet 5 PC Software System, Topcon Medical Systems, Inc. (2013) Summary page 4.

## Most influential descendants
- K201273: ImageSPECTRUM (2020), 0 descendants of its own
- K190056: KOWA VK-2s (2019), 0 descendants of its own

## Indications for use
The Ophthalmic Software Platform RX is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display of patient, diagnostic, image data from Canon's mydriatic and non-mydriatic retinal cameras.

Source page: https://510kreport.com/device/K173689
Methodology: https://510kreport.com/methodology