# K201273: ImageSPECTRUM

- Pathway: 510(k) (Traditional)
- Applicant: Canon, Inc.
- Decided: Sep 25, 2020 after 136 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: 8 generations back to K941234 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173689: Ophthalmic Software Platform RX, Canon Inc. -Medical Equipment Group (2018) Summary page 4.
- K123208: Digital Retinal Camera, Canon Inc. -Medical Equipment Group (2013) Summary page 4.

## Indications for use
The imageSPECTRUM V6 is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display patient, diagnostic and image data from Canon digital retinal cameras. It is also indicated for review of patient, diagnostic and image data and measurement by trained healthcare professional.

Source page: https://510kreport.com/device/K201273
Methodology: https://510kreport.com/methodology