# K193319: XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Vasoptic Medical, Inc.
- Decided: Jun 1, 2020 after 182 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943955 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080180: Modification to Retinal Function Imager (Rfi), Optical Imaging, Ltd. (2008) Summary page 4.

## Indications for use
The XyCAM RI System is intended to capture, store, and display images of dynamic blood flow changes in the human retina, and to provide quantitative outputs of relative blood flow information.

Source page: https://510kreport.com/device/K193319
Methodology: https://510kreport.com/methodology