ClearanceBrief
510(k) K031333 ยท IZI System, X-Ray, Angiographic

PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2

ApplicantPhilips Medical Systems North America, Inc., Da Best, NL
DecisionSubstantially Equivalent, May 13, 2003
ReceivedApr 28, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K031333

DateFirm and productCodeLinked 510(k)
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
Open, Classified
OWBNone listed
Feb 16, 2024PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura X
Open, Classified
OWBNone listed
Feb 19, 2019Philips Medical Systems Nederlands
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular,
Terminated
IZINone listed
Feb 19, 2019Philips Medical Systems Nederlands
Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD2
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Mar 22, 2017Philips Electronics North America Corporation
Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10
Terminated
OWBNone listed
Mar 22, 2017Philips Electronics North America Corporation
The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20
Terminated
OWBNone listed
Sep 24, 2014Philips Medical Systems, Inc.
Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper
Terminated
IZINone listed
Apr 25, 2012Philips Healthcare Inc.
Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.
Terminated
IZINone listed
Aug 10, 2011Philips Healthcare Inc.
Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR table) Allura Xper FD20- High resolution fixed-x ray Allura Xper FD20/10 Allura Xper FD20/20 Allura CV20
Terminated
IZINone listed
Sep 22, 2010Philips Medical Systems North America Co. Phillips
Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet). Intended use for Ang
Terminated
IZINone listed
Sep 22, 2010Philips Medical Systems North America Co. Phillips
BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane. The BIPLANE system has two C-arms and it allows the operator to im
Terminated
IZINone listed
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Allura XPER 10/10
Terminated
IZINone listed
Jan 25, 2007Philips Medical Systems North America Co. Phillips
FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector
Terminated
IZINone listed
Nov 14, 2006Philips Medical Systems North America Co. Phillips
Allura X-per FD 10/10 x-ray, and fluoroscopy
Terminated
IZINone listed
Feb 28, 2006Philips Medical Systems North America Co. Phillips
Allura Xper FD10/10 x-ray system
Terminated
IZINone listed
Nov 29, 2005Philips Medical Systems North America Co. Phillips
AD5 table for use with Integris and Integris Allura x-ray systems
Terminated
IZINone listed
Nov 29, 2005Philips Medical Systems North America Co. Phillips
AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.
Terminated
IZINone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.