ClearanceBrief
510(k) K133292 ยท OWB Interventional Fluoroscopic X-Ray System

ALLURA XPER FD; OR TABLE

ApplicantPhilips Medical Systems Nederland B.V., Best Noord-Brabant, NL
DecisionSubstantially Equivalent, Mar 5, 2014
ReceivedOct 25, 2013
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K133292

DateFirm and productCodeLinked 510(k)
Aug 10, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Open, Classified
OWBNone listed
Aug 5, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 7220
Open, Classified
OWBNone listed
Aug 5, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Open, Classified
OWBNone listed
Jun 16, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD
Open, Classified
OWBNone listed
May 28, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225),
Open, Classified
OWBNone listed
May 28, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product Name: Allura Xper FD10C; Model number: 722001;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10F; Model Number: 722002;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10; Model Number: 722003;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Model Number: 722005;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Number: 722006;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane; Model Number: 722008;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10; Model Number: 722010;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Model Number: 722011;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Number: 722012;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane; Model Number: 722013;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table; Model Number: 722023;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10; Model Number: 722026;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Model Number: 722027;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Number: 722028;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; Model Number: 722029;
Open, Classified
OWBNone listed
Jan 13, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Model Number: 722038;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 25, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Open, Classified
OWBNone listed
Sep 3, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, M
Open, Classified
OWBNone listed
Jul 29, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allu
Open, Classified
OWBNone listed
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
Open, Classified
OWBNone listed
Feb 16, 2024PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD1
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: FlexVision PC Allura Xper Model Name - Model Number:
Open, Classified
OWBNone listed
Mar 14, 2018Philips Electronics North America Corporation
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human pa
Terminated
OWBNone listed
Feb 24, 2018Philips Electronics North America Corporation
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular
Terminated
OWBNone 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
Jan 20, 2017Philips Electronics North America Corporation
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies),
Terminated
OWBNone listed
Jan 20, 2017Philips Electronics North America Corporation
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomie
Terminated
OWBNone listed

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