Atlas FDA

ALLURA XPER FD10

FDA 510(k) clearance K041949 · decided 2004-07-30

Clearance details

K-number
K041949
Device name
ALLURA XPER FD10
Applicant
Philips Medical Systems North America Co.
Decision
Substantially Equivalent
Date received
2004-07-20
Decision date
2004-07-30
Days to decision
10 days
Clearance type
Traditional
Product code
IZI
Device class
2
Regulation number
892.1600
Medical specialty
Radiology
Advisory committee
Radiology
Location
The Netherlands, NL
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
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 Catalog (1) 722003 (2) 722010 (3)722026 recall (Z-1077-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-04
Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging recall (Z-3225-2018)Philips Electronics North America Corporation2018-09-21
AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging recall (Z-3226-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging ap recall (Z-3227-2018)Philips Electronics North America Corporation2018-09-21
AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging a recall (Z-3228-2018)Philips Electronics North America Corporation2018-09-21
AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging appl recall (Z-3229-2018)Philips Electronics North America Corporation2018-09-21
AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging a recall (Z-3230-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applica recall (Z-0923-2017)Philips Electronics North America Corporation2017-01-20
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: TH recall (Z-0810-2016)Philips Electronics North America Corporation2016-02-16
Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl recall (Z-2976-2011)Philips Healthcare Inc.2011-08-10
Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 recall (Z-1368-2011)Philips Medical Systems North America Co. Phillips2011-03-22
Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x recall (Z-0124-2011)Philips Medical Systems North America Co. Phillips2010-10-22
Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular recall (Z-0125-2011)Philips Medical Systems North America Co. Phillips2010-10-22
AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non- recall (Z-1642-2008)Philips Medical Systems North America Co. Phillips2008-09-01
Allura Xper FD 10/10 x-ray, angiographic system recall (Z-0161-2007)Philips Medical Systems North America Co. Phillips2006-11-08
Allura Xper FD 10 x-ray, angiographic system recall (Z-0162-2007)Philips Medical Systems North America Co. Phillips2006-11-08
AD5 table, modified, used with the XPER x-ray systems. The modification on the table is th recall (Z-0208-06)Philips Medical Systems North America Co. Phillips2005-11-29
AD6 table, modified, used with the XPER systems. The modification on the table is the cabl recall (Z-0209-06)Philips Medical Systems North America Co. Phillips2005-11-29