Atlas FDA

Allura Xper FD series and Allura Xper OR Table series

FDA 510(k) clearance K161563 · decided 2016-07-29

Clearance details

K-number
K161563
Device name
Allura Xper FD series and Allura Xper OR Table series
Applicant
Philips Medical Systems Nederland B.V.
Decision
Substantially Equivalent
Date received
2016-06-06
Decision date
2016-07-29
Days to decision
53 days
Clearance type
Traditional
Product code
OWB
Device class
2
Regulation number
892.1650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Best Noord-Brabant, NL
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722 recall (Z-2928-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-08-10
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluor recall (Z-2893-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-08-05
Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C recall (Z-2412-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-06-16
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), A recall (Z-2258-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-05-28
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, recall (Z-2259-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-05-28
Product Name: Allura Xper FD10C; Model number: 722001; recall (Z-1062-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD10F; Model Number: 722002; recall (Z-1063-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD10; Model Number: 722003; recall (Z-1064-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD10/10; Model Number: 722005; recall (Z-1065-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD20; Model Number: 722006; recall (Z-1066-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD20 Biplane; Model Number: 722008; recall (Z-1067-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD10; Model Number: 722010; recall (Z-1068-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD10/10; Model Number: 722011; recall (Z-1069-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD20; Model Number: 722012; recall (Z-1070-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD20 Biplane; Model Number: 722013; recall (Z-1071-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD20 OR Table; Model Number: 722023; recall (Z-1072-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD10; Model Number: 722026; recall (Z-1073-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD10/10; Model Number: 722027; recall (Z-1074-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD20; Model Number: 722028; recall (Z-1075-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD20/10; Model Number: 722029; recall (Z-1076-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD20/20; Model Number: 722038; recall (Z-1077-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-13
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbe recall (Z-2623-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) nu recall (Z-2624-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: recall (Z-2625-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbe recall (Z-2626-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: recall (Z-2627-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510 recall (Z-2628-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) recall (Z-2629-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K1 recall (Z-2630-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K1 recall (Z-2631-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K1 recall (Z-2632-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K1 recall (Z-2633-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K1 recall (Z-2634-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K recall (Z-2635-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-25
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: recall (Z-2189-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-07-29
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Mo recall (Z-0676-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-12-12
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray Sys recall (Z-2716-2024)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-08-22
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay o recall (Z-1151-2024)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-02-16
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dua recall (Z-1156-2024)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-02-16
Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 72200 recall (Z-0558-2024)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2023-12-15
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluor recall (Z-2485-2023)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2023-08-30
Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional recall (Z-0476-2022)Philips North America Llc2022-01-10