# K062328: Vitreaaccess, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Aug 21, 2006 after 11 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 9 generations back to K913770 (1991). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040876: Iconnection, Version 3.2.0.0 Medical Image Processing Software, Vital Images, Inc. (2004) Summary page 1.
- K061624: Vitrea, Version 3.9, Vital Images, Inc. (2006) Summary page 1.

## Indications for use
VitreaACCESS software is intended to be used for remote review 6f Vitrea2 Software outputs, such as: processing, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.

Source page: https://510kreport.com/device/K062328
Methodology: https://510kreport.com/methodology