Atlas FDA

ALLURA XPER FD20

FDA 510(k) clearance K033737 · decided 2003-12-09

Clearance details

K-number
K033737
Device name
ALLURA XPER FD20
Applicant
Philips Medical Systems North America, Inc.
Decision
Substantially Equivalent
Date received
2003-11-28
Decision date
2003-12-09
Days to decision
11 days
Clearance type
Traditional
Product code
OWB
Device class
2
Regulation number
892.1650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Da Best, NL
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, recall (Z-1142-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. recall (Z-1143-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. recall (Z-1144-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013. recall (Z-1145-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035. recall (Z-1147-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Allura Xper FD20/10; Catalog numbers: 722029 recall (Z-1148-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Allura Xper FD20/15; Catalog numbers: 722058 recall (Z-1149-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Allura Xper FD20/20; Catalog numbers: 722038 recall (Z-1150-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Allura CV20; Catalog numbers: 722031 recall (Z-1151-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). recall (Z-1154-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. recall (Z-1158-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). recall (Z-1159-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY); recall (Z-1160-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028 recall (Z-1080-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-04
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay o recall (Z-1144-2024)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-02-16
Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging ap recall (Z-3221-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging ap recall (Z-3222-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular im recall (Z-3223-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular im recall (Z-3224-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applica recall (Z-0922-2017)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
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications. recall (Z-0764-2016)Philips Electronics North America Corporation2016-02-05
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2. recall (Z-0181-2015)Philips Medical Systems, Inc.2014-11-07
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035 recall (Z-0182-2015)Philips Medical Systems, Inc.2014-11-07
Allura X-ray System. The Allura X-ray System is an angiographic X-ray system. recall (Z-1462-2012)Philips Healthcare Inc.2012-04-25
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
MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integr recall (Z-2448-2010)Philips Medical Systems North America Co. Phillips2010-09-22
BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5 recall (Z-2449-2010)Philips Medical Systems North America Co. Phillips2010-09-22
Philips Allura XPER FD 20/10 Angiographic X-ray system. This system with Velara Generator recall (Z-2475-2010)Philips Medical Systems North America Co. Phillips2010-09-22
Philips Allura XPER FD20 Angiographic X-ray system. This system with Velara Generator can recall (Z-2476-2010)Philips Medical Systems North America Co. Phillips2010-09-22
Allura XPER FD20/10 recall (Z-0348-2009)Philips Medical Systems North America Co. Phillips2009-09-24
Allura XPER FD20 recall (Z-0349-2009)Philips Medical Systems North America Co. Phillips2009-09-24
Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021 recall (Z-0329-2008)Philips Medical Systems North America Co. Phillips2007-12-07
Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021 recall (Z-0330-2008)Philips Medical Systems North America Co. Phillips2007-12-07
Allura Xper FD 20/10 x-ray, and fluoroscopy recall (Z-0166-2007)Philips Medical Systems North America Co. Phillips2006-11-14
Allura Xper FD10 x-ray system recall (Z-0582-06)Philips Medical Systems North America Co. Phillips2006-02-28
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