# K262120: Avara Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Avara Software
- Decided: Jul 10, 2026 after 17 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: 1 generation back to K222320 (2022). 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)
- K222320: MedDream, Softneta Uab (2022) Summary page 6.

## Indications for use
Avara Viewer is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM data, including mammographic images. It supports the physician in diagnosis. For primary image diagnosis in Mammography, only uncompressed or non-lossy compressed images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. Mobile device display is not intended for diagnostic purposes.

Source page: https://510kreport.com/device/K262120
Methodology: https://510kreport.com/methodology