# K973482: Philips Integris V5000 and BV5000

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Nov 10, 1997 after 56 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910370 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910370: Philips Integris V3000 and V4000, Philips Medical Systems, Inc. (1991) Summary page 1.

## Most influential descendants
- K092713: Spectre Wireless Encrypted Footswitch and Hand Switch System (2010), 0 descendants of its own

## Recalls of this device
- Nov 3, 2015 · Class II · Z-0722-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Nov 3, 2015 · Class II · Z-0723-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Nov 3, 2015 · Class II · Z-0724-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Nov 3, 2015 · Class II · Z-0725-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

## Indications for use
The Philips INTEGRIS V5000 and BV5000 system family is intended for use in dedicated vascular and neurovascular applications, including diagnostic and interventional procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography as well as PTA’s stent placements, embolisations, and thrombolysis. The systems are also intended for use in mixed cardiac/vascular/neuro applications and also non vascular interventions.

Source page: https://510kreport.com/device/K973482
Methodology: https://510kreport.com/methodology