ClearanceBrief
510(k) K130638 ยท OWB Interventional Fluoroscopic X-Ray System

ALLURACLARITY XPER FD SERIES X-RAY SYSTEM

ApplicantPhilips Medical Systems Nederland B.V., Best, NL
DecisionSubstantially Equivalent, Jun 28, 2013
ReceivedMar 11, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K130638

DateFirm and productCodeLinked 510(k)
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
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: Imaging Processing PC, Host PC, FlexVision PC Allura X
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
Aug 2, 2023PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 and FD20. X-ray Imaging System.
Open, Classified
OWBNone listed

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