# K022899: Philips Integris Allura Flat Detector Release 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Nov 22, 2002 after 80 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K890348 (1989). 6 ancestors in all.
114 later devices descend from it; 1 cites it directly.
10 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020055: Philips Integris Allura 9 with FD Option, Philips Medical Systems (2002) Summary page 1.

## Most influential descendants
- 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
- K101311: EP Navigator R3 (2010), 41 descendants of its own

## Recalls of this device
- Oct 7, 2010 · Not classified · Z-1654-2011: A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown.
- Feb 4, 2010 · Not classified · Z-2448-2010: A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem could only resolved by a warm or cold system restart. In exceptional cases the power convert
- Dec 10, 2008 · Not classified · Z-0347-2009: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Dec 10, 2008 · Not classified · Z-0350-2009: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Oct 23, 2008 · Not classified · Z-2474-2010: A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and henc
- Oct 23, 2008 · Not classified · Z-2477-2010: A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and henc
- Dec 14, 2006 · Not classified · Z-0369-2007: Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
- Dec 14, 2006 · Not classified · Z-0368-2007: Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.

## Indications for use
The Philips Integris Allura Flat Detector release 1.0 system is intended for use in cardiovascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.

Source page: https://510kreport.com/device/K022899
Methodology: https://510kreport.com/methodology