FDA.reportPublic FDA data

Philips IntelliSite Pathology Solution

Primary DI
00884838124349
Brand
Philips IntelliSite Pathology Solution
Company
Philips Medical Systems Nederland B.V.
Model
6.x upgrade
Catalog number
760053
Device description
Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system
Published
2025-09-01
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838124349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838124349008848381243498848381243490884838124349

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
00884838123786Multimodality Simulation Workspace (MM Sim)1.0Multimodality Simulation Workspace (MM Sim)1.07283492026-06-07
00884838123793Multimodality Simulation Workspace (MM Sim)1.0 UpgradeMultimodality Simulation Workspace (MM Sim)1.0 Upg7283512026-06-07
00884838123748Spectral CT VeridaSpectral CT Verida7283452026-05-26
00884838126398Spectral CT Verida RTSpectral CT Verida RT7283572026-05-26
00884838127555Upgrade Spectral CT VeridaUpgrade Spectral CT Verida7283562026-05-26
00884838127562Upgrade Spectral CT Verida RTUpgrade Spectral CT Verida RT7283722026-05-26
00884838127876Upgrade Spectral CT 7500 SW5.4Upgrade Spectral CT 7500 SW5.47283752026-05-26
00884838127883Upgrades Spectral CT 7500 RT SW5.4Upgrades Spectral CT 7500 RT SW5.47283552026-05-26
00884838128187IngeniaBlueSeal SE7822132026-04-07
00884838128194IngeniaBlueSeal XE7822142026-04-07
00884838128200IngeniaIngenia Elition S7822162026-04-07
00884838128217IngeniaIngenia Elition X7822172026-04-07
00884838128224MR 7700MR 77007822182026-04-07
00884838128231IngeniaUpgrades dStream to R137822192026-04-07
00884838128248IngeniaEvolution Upgrade 1.5T7822202026-04-07
00884838128255IngeniaEvolution Upgrade 3.0T7822212026-04-07
00884838128262IngeniaSmartPath to Ingenia Elition X7822222026-04-07
00884838128293MR 7700Upgrade to MR 77007822252026-04-07
00884838128309MR 7700SmartPath to MR 77007822262026-04-07
00884838128316IngeniaBlueSeal QE7822152026-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336206737VENTANA DP 600 slide scannerRoche Diagnostics GmbHPSY2025-12-15
00884838124325Philips 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
00884838092105Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2024-07-15
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