Allura Xper FD series and Allura Xper OR Table series— 510(k) K162859
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K162859 for Allura Xper FD series and Allura Xper OR Table series, Substantially Equivalent on 2016-12-02. 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 K162859
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-2503-2025 — 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 FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.
- Z-2189-2025 — Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.
- Z-1076-2025 — Allura CV20 System Code: 722031
- Z-1077-2025 — Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
- Z-1078-2025 — AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
- Z-1079-2025 — Allura Xper FD10C System Code: (1) 722001
- Z-1080-2025 — AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
- Z-1081-2025 — AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
- Z-1082-2025 — AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
- Z-1083-2025 — AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
- Z-1084-2025 — AlluraXperFD20/10 System Code: (1) 722029
- Z-1085-2025 — Allura Xper FD20/20 System Code: (1) 722038
- Z-1086-2025 — AlluraXperFD20/15 System Code: (1) 722058
- Z-1142-2025 — Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
- Z-1143-2025 — Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
- Z-1144-2025 — Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
- Z-1145-2025 — Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
- Z-1146-2025 — Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
- Z-1147-2025 — Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162859.
Data sourced from openFDA. This site is unofficial and independent of the FDA.