510(k) K130638 ยท OWB Interventional Fluoroscopic X-Ray System
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
| Applicant | Philips Medical Systems Nederland B.V., Best, NL |
| Decision | Substantially Equivalent, Jun 28, 2013 |
| Received | Mar 11, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130638
| 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. 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 |
| Feb 16, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems.
Allura Xper Model Name - Model Number:
Allura Xper FD1 Open, Classified |
OWB | None listed |
| Feb 16, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems.
Affected PCs: Imaging Processing PC, Host PC, FlexVision PC
Allura X Open, Classified |
OWB | None listed |
| Feb 16, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems.
Affected PCs: FlexVision PC
Allura Xper Model Name - Model Number:
Open, Classified |
OWB | None listed |
| Aug 2, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10 and FD20. X-ray Imaging System. Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.