510(k) K102005 · OWB Interventional Fluoroscopic X-Ray System

ALLURA XPER OR TABLE SERIES

Applicant	Philips Medical Systems North America, Inc., Bothell WA, US
Decision	Substantially Equivalent, Aug 9, 2010
Received	Jul 15, 2010
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K102005

Date	Firm and product	Code	Linked 510(k)
Aug 5, 2026	PHILIPS 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	OWB	None listed
Aug 5, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System. Open, Classified	OWB	None listed
Jun 16, 2026	PHILIPS 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	OWB	None listed
May 28, 2026	PHILIPS 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	OWB	None listed
May 28, 2026	PHILIPS 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	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Product Name: Allura Xper FD10C; Model number: 722001; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10F; Model Number: 722002; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10; Model Number: 722003; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10/10; Model Number: 722005; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20; Model Number: 722006; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20 Biplane; Model Number: 722008; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10; Model Number: 722010; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10/10; Model Number: 722011; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20; Model Number: 722012; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20 Biplane; Model Number: 722013; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20 OR Table; Model Number: 722023; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10; Model Number: 722026; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10/10; Model Number: 722027; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20; Model Number: 722028; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/10; Model Number: 722029; Open, Classified	OWB	None listed
Jan 13, 2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/20; Model Number: 722038; Open, Classified	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 25, 2025	PHILIPS 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	OWB	None listed
Sep 3, 2025	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper Open, Classified	OWB	None listed
Sep 3, 2025	PHILIPS 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	OWB	None listed
Mar 22, 2017	Philips 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	OWB	None listed
Feb 5, 2016	Philips Electronics North America Corporation Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications. Terminated	OWB	None listed
Mar 2, 2015	Philips Medical Systems, Inc. Philips Medical System Allura Xper X-Ray Angiographic Terminated	IZI	None listed

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