# K020055: Philips Integris Allura 9 with FD Option

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Mar 15, 2002 after 66 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890348 (1989). 5 ancestors in all.
124 later devices descend from it; 2 cite it directly.
10 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984545: Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems, Philips Medical Systems North America, Inc. (1999) Summary page 1.
- K993037: LCV+ Version 2, Ge Medical Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K022899: Philips Integris Allura Flat Detector Release 1.0 (2002), 114 descendants of its own
- K031333: Philips Integris Allura Flat Detector Release 1.2 (2003), 113 descendants of its own
- K041949: Allura Xper FD10 (2004), 64 descendants of its own
- K031836: Philips Fresco Release 1 (2003), 51 descendants of its own
- K062650: EP Navigator Software (2006), 49 descendants of its own

## Recalls of this device
- Oct 12, 2005 · Not classified · Z-0206-06: Potential for high voltage exposure involving the injector interface connector of patient support tables.
- Oct 12, 2005 · Not classified · Z-0207-06: Potential for high voltage exposure involving the injector interface connector of patient support tables.

## Indications for use
The Philips Integris Allura 9 system with FD Option is intended for use in cardiac imaging applications including diagnostic, interventional procedures (such as PTCA, stent placing, atherctomies,) pacemaker implantations, and electrophysiology (EP.)

Source page: https://510kreport.com/device/K020055
Methodology: https://510kreport.com/methodology