FDA.reportPublic FDA data

Philips IntelliSite Pathology Solution

Primary DI
00884838092105
Brand
Philips IntelliSite Pathology Solution
Company
Philips Medical Systems Nederland B.V.
Model
5.1
Catalog number
760001
Device description
Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system.
Published
2024-07-15
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
PSYWhole Slide Imaging System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSYWhole Slide Imaging SystemPathology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233204000Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.2024-06-24PSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838092105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838092105008848380921058848380921050884838092105

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide digital imaging scanner IVDA mains electricity (AC-powered) device designed to be used in a histopathology laboratory to scan clinical specimens on microscope slides, at a microscopic level, to produce images in a digital format. Also known as a whole slide scanner or digital pathology slide scanning system, it is a bench-top unit with slide tray slots, high-resolution cameras, a user interface, and integrated software for image creation, viewing, and management to aid the pathologist to review and interpret slide images.

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
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
00884838059245Allura 3D-CAAllura 3D-CA - 30010092016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04582389010734NanoZoomer S20MD Slide scanner systemHAMAMATSU PHOTONICS K.K.PSY2026-08-03
04582389011236NanoZoomer S540MD Slide scanner systemHAMAMATSU PHOTONICS K.K.PSY2026-08-03
04582389011267Agilent S540MD Slide Scanner SystemHAMAMATSU PHOTONICS K.K.PSY2026-08-03
07613336206737VENTANA DP 600 slide scannerRoche Diagnostics GmbHPSY2025-12-15
00884838124325Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2025-09-01
00884838124349Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2025-09-01
00860006054595Concentriq AP-DxProscia Inc.PSY2025-05-08
05415334055919BarcoBarco NVPSY2025-04-08
05415334055926BarcoBarco NVPSY2025-04-08
05415334056244BarcoBarco NVPSY2025-04-08
05415334056251BarcoBarco NVPSY2025-04-08
05051663010467EprediaSHANDON DIAGNOSTICS LIMITEDPSY2025-03-10
00884838121263Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2025-02-24
00860006054557Concentriq AP-Dx-US Proscia Inc.PSY2025-01-15
00884838121270Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2024-10-08
00860006054519Concentriq AP-DxProscia Inc.PSY2024-08-26
00815477020525Aperio GT 450 DX (US) ScannerLEICA BIOSYSTEMS IMAGING, INCPSY2024-05-31
05415334044289BARCOBarco NVPSY2023-12-19
05415334044371BARCOBarco NVPSY2023-12-19
00854904006039Synapse PathologyFujifilm Healthcare Americas CorporationPSY2023-06-16
04582389010659NanoZoomer S360MD Slide scanner systemHAMAMATSU PHOTONICS K.K.PSY2022-10-01
00815477020259Aperio AT2 DX ScannerLEICA BIOSYSTEMS IMAGING, INCPSY2020-01-23
00884838085640Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2017-12-15