ALLURA XPER FD10— 510(k) K041949

Name: FDA 510(k) clearance K041949
Creator: U.S. Food and Drug Administration
Published: 2004-07-30

Substantially Equivalent

Philips Medical Systems North America Co.

FDA 510(k) clearance K041949 for ALLURA XPER FD10, Substantially Equivalent on 2004-07-30. Applicant: Philips Medical Systems North America Co.. Device class: 2.

Clearance details

Applicant: Philips Medical Systems North America Co.
Product code: Code IZI
Device class: Class 2
Regulation: 21 CFR 892.1600
Advisory panel: Radiology
Date received: 2004-07-20
Decision date: 2004-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Netherlands, NL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K041949

K-number listed on FDA's recall record

Z-0001-2026 — Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0002-2026 — Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0003-2026 — Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0004-2026 — Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0005-2026 — Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0006-2026 — Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0007-2026 — Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0008-2026 — Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0009-2026 — Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0010-2026 — Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0011-2026 — Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0012-2026 — Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0013-2026 — Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0014-2026 — Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-0015-2026 — Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250903
Z-1077-2025 — Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026Class II·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·20250113
Z-1140-2019 — 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, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.Class II·Terminated·Philips Medical Systems Nederlands·20190219
Z-1141-2019 — 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 FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012 Allura Xper FD20 722013 Allura XPER FD20 BIPLANE 722014 Allura Xper FD10 OR Table 722015 Allura Xper FD20 OR Table 722019 Allura Xper FD10/10 OR Table 722020 Allura Xper FD20 Biplane OR Table 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722024 Allura Xper FD10/10 OR Table 722025 Allura Xper FD20 Biplane OR Table 722026 Allura Xper FD10 722027 Allura Xper FD10/10 722028 Allura Xper FD20 722029 Allura Xper FD20/10 722031 Allura CV20 722033 Allura Xper FD10 OR Table 722034 Allura Xper FD10/10 OR Table 722035 Allura Xper FD20 OR Table 722036 Allura Xper FD20/10 OR Table 722038 Allura Xper FD20/20 722039 Allura Xper FD20/20 OR Table 722058 Allura Xper FD20/15 722059 Allura Xper FD20/15 OR Table 722123 Field extensions Xper cardio 722124 Field extensions Xper vascular 722126 SmartPath to upgrade Allura to AlluraClarity cardio 722127 SmartPath to upgrade Allura to AlluraClarity vascular 722133 Field ext. Xper cardio systems R7.6 722134 Field ext. Xper vascular systems 722400 Cardio Vascular-Allura Centron 722030 INTEGRIS CV 722043 INTEGRIS Allura 15-12 (mono) Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.Class II·Terminated·Philips Medical Systems Nederlands·20190219
Z-3225-2018 — Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventionsClass II·Terminated·Philips Electronics North America Corporation·20180716
Z-3226-2018 — AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventionsClass II·Terminated·Philips Electronics North America Corporation·20180716

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041949.

Data sourced from openFDA. This site is unofficial and independent of the FDA.