# K140395: Vitrea Image Denoising Software

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: May 13, 2014 after 84 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: 4 generations back to K922470 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063391: Sapheneia Clarity, Sapheneia Commercial Products AB (2007) Summary page 1.

## Indications for use
Vitres Image Denoising software is intended to assist radiologists and specialists in the enhancement of CT and 3D-XA Image presentation by enabling noise reduction and contrast enhancement technique.

Source page: https://510kreport.com/device/K140395
Methodology: https://510kreport.com/methodology