# K110869: CARA

- Pathway: 510(k) (Traditional)
- Applicant: Diagnos, Inc.
- Decided: Jul 14, 2011 after 107 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K896095 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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 1.

## Recalls of this device
- Jan 11, 2022 · Class II · Z-0826-2022: Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.

## Indications for use
CARA is a comprehensive software platform intended for importing, processing, and storing of color fundlus images as well as visualization of original and enhanced image through computerized networks.

Source page: https://510kreport.com/device/K110869
Methodology: https://510kreport.com/methodology