Software Version 1.0.0 · Last Updated: July 13, 2026
Electronic Label
AVARA VIEWER
Software Version 1.0.0
℞ OnlyAvara Software LLC
5015 4th St N, St Petersburg, FL, 33703
| Field | Value |
|---|---|
| Device Name | Avara Viewer |
| Software Version | 1.0.0 |
| Product Code | LLZ |
| Regulation | 21 CFR 892.2050 |
| Device Class | II |
| Type of Use | Prescription Use (21 CFR 801 Subpart D) |
| 510(k) Number | K262120 |
| UDI | G874AVARAVIEWER0010 |
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.
Caution
Federal law restricts this device to sale by or on the order of a licensed healthcare provider.
Full Instructions for Use are provided in AVA-5-IFU-001, accessible at avarasoftware.com/viewer-ifu and available from Avara Software LLC upon request at support@avarasoftware.com.
WebGL2-capable browser (Chromium, Firefox, or WebKit), HTTPS network connectivity, Web Workers support, 8GB RAM absolute minimum. See AVA-5-IFU-001 Section 6 for complete specifications.
The Avara Viewer is a software-only device delivered electronically. No physical installation media is required. The device is accessed via web browser through the Avara platform or via the Avara SDK integration. The current software version is displayed within the application interface at all times.