ClearanceBrief
510(k) K041949 ยท IZI System, X-Ray, Angiographic

ALLURA XPER FD10

ApplicantPhilips Medical Systems North America Co., The Netherlands, NL
DecisionSubstantially Equivalent, Jul 30, 2004
ReceivedJul 20, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K041949

DateFirm and productCodeLinked 510(k)
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Oct 1, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Open, Classified
OWBNone listed
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
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
Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone listed
Sep 21, 2018Philips Electronics North America Corporation
AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Terminated
IZINone 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
Jan 20, 2017Philips Electronics North America Corporation
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pace
Terminated
IZINone listed
Dec 9, 2016Philips Electronics North America Corporation
Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura
Terminated
IZINone listed
Dec 9, 2016Philips Electronics North America Corporation
Velara Generator with an old Firmware version used with the Philips Integris BH5000
Terminated
IZINone listed
Feb 16, 2016Philips Electronics North America Corporation
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C
Terminated
IZINone listed
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Usage: The A
Terminated
OWBNone listed
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 BIPLA
Terminated
OWBNone listed
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, i
Terminated
OWBNone listed
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics,
Terminated
OWBNone listed
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics
Terminated
OWBNone listed
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, inte
Terminated
OWBNone listed
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, in
Terminated
OWBNone listed
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics,
Terminated
OWBNone listed
Feb 3, 2015Philips Medical Systems, Inc.
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics
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
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
Mar 22, 2011Philips Medical Systems North America Co. Phillips
Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allura CV20. Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and
Terminated
IZINone listed
Oct 22, 2010Philips Medical Systems North America Co. Phillips
Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement a
Terminated
IZINone listed
Oct 22, 2010Philips Medical Systems North America Co. Phillips
Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement
Terminated
IZINone listed
Sep 1, 2008Philips Medical Systems North America Co. Phillips
AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option.
Terminated
IXINone listed
Nov 8, 2006Philips Medical Systems North America Co. Phillips
Allura Xper FD 10/10 x-ray, angiographic system
Terminated
IZINone listed
Nov 8, 2006Philips Medical Systems North America Co. Phillips
Allura Xper FD 10 x-ray, angiographic system
Terminated
IZINone listed
Nov 29, 2005Philips Medical Systems North America Co. Phillips
AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the cables used for connecting to the XPER systems.
Terminated
IZINone listed
Nov 29, 2005Philips Medical Systems North America Co. Phillips
AD6 table, modified, used with the XPER systems. The modification on the table is the cables used for connecting to the XPER systems.
Terminated
IZINone listed

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