FDA.reportPublic FDA data

Allura Xper FD

Primary DI
00884838059092
Brand
Allura Xper FD
Company
Philips Medical Systems Nederland B.V.
Model
Allura Xper FD10/10 OR Table
Catalog number
722024
Device description
Biplane Interventional X-Ray System with floor-mounted frontal stand (10-inch flat detector), ceiling-mounted lateral stand ( 10-inch flat detector) and interface for an OR table.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IZISystem, X-Ray, Angiographic
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130638000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130638000ALLURACLARITY XPER FD SERIES X-RAY SYSTEMPhilips Medical Systems Nederland B.V.2013-06-28OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838059092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838059092008848380590928848380590920884838059092

GMDN Terms#

Term, Definition table
TermDefinition
Stationary angiographic x-ray system, digitalA stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413819707
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838120433SmartCTSmartCT - 30010182026-09-28
00884838127746Radiology Operations Command Center Console18080072025-03-14
00884838122154EchoNavigatorEchoNavigator R5.00010112026-03-25
00884838107557Image Management15.X8390602024-11-15
00884838107571Desktop Diagnostic Viewer15.X8390622024-11-15
00884838107588Web Diagnostic Viewer15.X8390632024-11-15
00884838107595Enterprise Viewer15.X8390642024-11-15
00884838101883Dynamic Coronary RoadmapDynamic Coronary Roadmap - 30010162020-11-10
00884838101890StentBoost LiveStentBoost Live - 20010172020-11-10
00884838106437EchoNavigatorEchoNavigator - 42023-02-10
00884838103504Vue PACS (Web Diagnostic)Vue PACS (Web Diagnostic) - 1289860102021-06-03
00884838085732SmartCTSmartCT - 10010182021-02-25
00884838090668Onvision systemOnvision system4535619434922020-08-07
00884838100336Vue PACSVue PACS - 1289864242020-05-18
00884838100350Vue PACS (Diagnostic)Vue PACS (Diagnostic) - 1211494182020-05-18
00884838100367Vue MotionVue Motion - 1210179792020-05-18
00884838059184EP navigatorEP navigator - 50000712016-09-24
00884838059191Interventional WorkspotInterventional Workspot - 10010002016-09-24
00884838059207HeartNavigatorHeartNavigator - 20010012016-09-24
008848380592213D Roadmap3D Roadmap - 10010032016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838120433SmartCTPhilips Medical Systems Nederland B.V.OWB2026-09-28
00190376649474CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652313CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652320CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652337CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376668307CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
BN981BN002020Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
BN981BN00202BX101Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-09-21
00850079606098EmitterOXOS Medical, Inc.OWB2026-09-21
00850079606104CassetteOXOS Medical, Inc.OWB2026-09-21
04547410582901FDR CROSS SlimFUJIFILM CORPORATIONOWB2026-08-14
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.OWB2026-07-08
05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
04056481145613Vascular Navigation PADBrainlab SEOWB2025-09-11
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHOWB2025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHOWB2025-07-30
00850073646007TrackXTrackX Technology, LLCOWB2025-07-24
00850073646014TrackXTrackX Technology, LLCOWB2025-07-24
08600105136202RE3Digital Surgery Systems, Inc.IZI2025-07-15
08800018422601EXTRON 3DRTECH CorporationOWB2025-06-17