Atlas FDA

ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES

FDA 510(k) clearance K130842 · decided 2013-05-21

Clearance details

K-number
K130842
Device name
ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
Applicant
Philips Medical Systems Nederland B.V.
Decision
Substantially Equivalent
Date received
2013-03-27
Decision date
2013-05-21
Days to decision
55 days
Clearance type
Traditional
Product code
IZI
Device class
2
Regulation number
892.1600
Medical specialty
Radiology
Advisory committee
Radiology
Location
Best Noord-Brabant, NL
Third-party review
Yes
Expedited review
No

+ Add to Predicate Builder ◉ Watch Philips Medical Systems Nederland B.V.

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
780 nm SPY Portable Handheld Imaging (SPY-PHI) System (K261037)Stryker Endoscopy2026-05-28
SURGIMAGE SIM 1000H Fluorescence Imaging Platform (K253181)Surgimage Corporation2026-05-13
IC-Flow™ Imaging System 2.0 (K243645)Diagnostic Green GmbH2025-09-22
Affirm 800 (K243077)Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)2025-06-27
Modus IR (K231986)Synaptive Medical, Inc.2024-03-25
EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (K234090)Surgvision GmbH2024-03-20
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (K231075)Carl Zeiss Meditec, Inc.2023-06-20
SPY Portable Handheld Imaging (SPY-PHI) System (K230727)Novadaq Technologies Ulc (A Part of Stryker)2023-06-05
EXPLORER AIR® II (K222240)Surgvision GmbH2023-02-28
Explorer Air II (K214097)Surgvision GmbH2022-02-25
DIR 800 (K202391)Aesculap, Inc.2021-01-21
Asimov-MKS Imaging System (K192761)Onlume, Inc.2020-01-17

Recalls involving this device

RecordFirmDate
Philips Allura under the following System Descriptions and corresponding model numbers: 1. recall (Z-2891-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-08-05
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 FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K1 recall (Z-0001-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K recall (Z-0002-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s recall (Z-0003-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K1 recall (Z-0004-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K recall (Z-0005-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K1020 recall (Z-0006-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k recall (Z-0007-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 5 recall (Z-0008-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, recall (Z-0009-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, recall (Z-0010-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, recall (Z-0011-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, recall (Z-0012-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, recall (Z-0013-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K1 recall (Z-0014-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K13063 recall (Z-0015-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-10-01
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 System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled a recall (Z-2503-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-03