FDA.reportPublic FDA data

IntelliSpace Portal

Primary DI
00884838073876
Brand
IntelliSpace Portal
Company
Philips Medical Systems Nederland B.V.
Model
8.x
Device description
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAKSystem, x-ray, tomography, computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060937000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060937000BRILLIANCE VOLUMEPhilips Medical Systems (Cleveland), Inc.2006-06-05JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838073876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838073876008848380738768848380738760884838073876

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)722-9377healthcare@philips.com

Regulatory Flags#

DUNS number
413819707
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884838059238MR-CT RoadmapMR-CT Roadmap - 10010042016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-09-21
00860015781925Bunkerhill Contrast AVCBunkerhill Health Inc.JAK2026-09-16
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00860015781901CAC (Gated) AlgorithmBunkerhill Health Inc.JAK2026-05-13
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00198953085950PhotonovaGE Medical Systems, L.L.C.JAK2026-05-11
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
00195278940292RevolutionGE Hangwei Medical Systems Company Ltd.JAK2025-02-28
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
00850025268301Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-20
00850025268257Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-05
00850025268295Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-08-13
10884521837102ILLUMISITECovidien LPJAK2024-08-09
10884521837126ILLUMISITECovidien LPJAK2024-08-09
10884521837133ILLUMISITECovidien LPJAK2024-08-09
10884521837140ILLUMISITECovidien LPJAK2024-08-09
10884521837157ILLUMISITECovidien LPJAK2024-08-09