# K233226: FlexView Diagnostic (v1.1.20)

- Pathway: 510(k) (Traditional)
- Applicant: Radical Imaging, LLC
- Decided: Jan 17, 2024 after 111 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: 2 generations back to K162011 (2016). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200546: ZeeroMED View, O3 Enterprise Srl (2020) Summary page 4.

## Most influential descendants
- K262449: AdvaView (2026), 0 descendants of its own
- K253784: 3DICOM MD Cloud (2026), 0 descendants of its own

## Indications for use
FlexView Diagnostic 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. FlexView Diagnostic enables qualified healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data. FlexView Diagnostic 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/K233226
Methodology: https://510kreport.com/methodology