# K253735: AV Vascular

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jan 22, 2026 after 59 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: 12 generations back to K971684 (1997). 138 ancestors in all.
No later device cites it as a predicate yet.
3 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153736: 3mensio Workstation, Pie Medical Imaging BV (2016) Summary page 5.
- K203216: The Multimodality Advanced Vessel Analysis, Philips Medical Systems Nederland B.V. (2020) Summary page 5.

## Indications for use
AV Vascular is indicated to assist users in the visualization, assessment and quantification of vascular anatomy on CTA and/or MRA datasets, in order to assess patients with suspected or diagnosed vascular pathology and to assist with pre-procedural planning of endovascular interventions.

Source page: https://510kreport.com/device/K253735
Methodology: https://510kreport.com/methodology