# K082196: Static Vessel Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Imedos GmbH
- Decided: Jun 16, 2009 after 316 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: 1 generation back to K011877 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System, Carl Zeiss Jena GmbH (2001)

## Indications for use
Static Vessel Analyzer (SVA) with VesselMap2 is intended to capture, display, store, and manipulate images of the eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed. Specifically, the VesselMap2 software is intended to be used for semiautomated measurement and calculation of the retinal artery/vein diameter ratio.

Source page: https://510kreport.com/device/K082196
Methodology: https://510kreport.com/methodology