# K223501: ViewFinder Software Version 1.1

- Pathway: 510(k) (Traditional)
- Applicant: Elaitra, Ltd.
- Decided: Apr 21, 2023 after 151 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 5 generations back to K033712 (2003). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212621: MAMMOVISTA B.smart, Siemens Medical Solutions USA, Inc. (2021) Summary page 5.

## Indications for use
ViewFinder is a dedicated softcopy review environment for both screening and diagnostic digital breast tomosynthesis. Its user interface and workflow have been optimized to support qualified interpreting physicians in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. ViewFinder provides visualization and image enhancement tools to aid a qualified interpreting physician in the review of digital breast tomosynthesis datasets. The qualified interpreting physician is responsible for making the diagnosis of the images presented.

Source page: https://510kreport.com/device/K223501
Methodology: https://510kreport.com/methodology