Philips IntelliSite Pathology Solution 760042

GUDID 00884838121263

Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system.

Philips Medical Systems Nederland B.V.

Microscope slide digital imaging scanner IVD
Primary Device ID00884838121263
NIH Device Record Key2e559c27-38d4-4c32-9664-2c972fddbbb4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhilips IntelliSite Pathology Solution
Version Model Number5.x IVDR
Catalog Number760042
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838121263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PSYWhole Slide Imaging System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-04
Device Publish Date2025-02-24

On-Brand Devices [Philips IntelliSite Pathology Solution]

008848380921055.1
00884838121270Whole Slide Imaging System. The device is an automated digital slide creation, viewing and manag
00884838121263Whole Slide Imaging System. The device is an automated digital slide creation, viewing and manag

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