Allura Xper FD series and Allura Xper OR Table series— 510(k) K161563
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K161563 for Allura Xper FD series and Allura Xper OR Table series, Substantially Equivalent on 2016-07-29. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nederland B.V.
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Best Noord-Brabant, NL
Recent devices under product code OWB
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- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)
- K253614 — EchoNavigator R5.0
- K260169 — AV Cardiac CT
Adverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . 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 K161563
K-number listed on FDA's recall record- Z-2928-2026 — Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
- Z-2893-2026 — Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
- Z-2412-2026 — 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 FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD20; Model # 722013 for Allura Xper FD20 Biplane; Model # 722015 for Allura Xper FD20 OR Table; Model # 722019 for Allura Xper FD10/10 OR Table; Model # 722020 for Allura Xper FD20 Biplane OR Table; Model # 722022 for Allura Xper FD10 OR Table; Model # 722023 for Allura Xper FD20 OR Table; Model # 722025 for Allura Xper FD20 Biplane OR Table; Model # 722026 for Allura Xper FD10; Model # 722027 for Allura Xper FD10/10; Model # 722028 for Allura Xper FD20; Model # 722029 for Allura Xper FD20/10; Model #722033 for Allura Xper FD10 OR Table; Model #722035 for Allura Xper FD20 OR Table; Model #722038 for Allura Xper FD20/20; Model #722039 for Allura Xper FD20/20 OR Table; Model #722058 for Allura Xper FD20/15; Model #722059 for Allura Xper FD20/15 OR Table.
- Z-2258-2026 — 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), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).
- Z-2259-2026 — 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 FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);
- Z-1062-2026 — Product Name: Allura Xper FD10C; Model number: 722001;
- Z-1063-2026 — Allura Xper FD10F; Model Number: 722002;
- Z-1064-2026 — Allura Xper FD10; Model Number: 722003;
- Z-1065-2026 — Allura Xper FD10/10; Model Number: 722005;
- Z-1066-2026 — Allura Xper FD20; Model Number: 722006;
- Z-1067-2026 — Allura Xper FD20 Biplane; Model Number: 722008;
- Z-1068-2026 — Allura Xper FD10; Model Number: 722010;
- Z-1069-2026 — Allura Xper FD10/10; Model Number: 722011;
- Z-1070-2026 — Allura Xper FD20; Model Number: 722012;
- Z-1071-2026 — Allura Xper FD20 Biplane; Model Number: 722013;
- Z-1072-2026 — Allura Xper FD20 OR Table; Model Number: 722023;
- Z-1073-2026 — Allura Xper FD10; Model Number: 722026;
- Z-1074-2026 — Allura Xper FD10/10; Model Number: 722027;
- Z-1075-2026 — Allura Xper FD20; Model Number: 722028;
- Z-1076-2026 — Allura Xper FD20/10; Model Number: 722029;
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161563.
Data sourced from openFDA. This site is unofficial and independent of the FDA.