# K262449: AdvaView

- Pathway: 510(k) (Special)
- Applicant: Advahealth Solutions, LLC
- Decided: Aug 14, 2026 after 29 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: 3 generations back to K162011 (2016). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233226: FlexView Diagnostic (v1.1.20), Radical Imaging, LLC (2024) Summary page 6.

## Indications for use
AdvaView is a software application used for reference and diagnostic viewing and analysis of multi-modality medical imaging and non-imaging data (e.g., video information) with associated reports and information. AdvaView enables qualified healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents, and data. AdvaView allows qualified users to perform simple and complex image manipulations (including window/level, markups, 3D visualization) and measurements. Not intended for primary diagnosis of mammographic images. Not intended for diagnostic use on mobile devices.

Source page: https://510kreport.com/device/K262449
Methodology: https://510kreport.com/methodology