Philips IntelliSite Pathology Solution

Whole Slide Imaging System

Philips Medical Systems Nederland B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Philips Intellisite Pathology Solution.

Pre-market Notification Details

Device IDK203845
510k NumberK203845
Device Name:Philips IntelliSite Pathology Solution
ClassificationWhole Slide Imaging System
Applicant Philips Medical Systems Nederland B.V. Veenpluis 6 Best,  NL 5684pc
ContactLiselotte Kornmann
CorrespondentLiselotte Kornmann
Philips Medical Systems Nederland B.V. Veenpluis 6 Best,  NL 5684pc
Product CodePSY  
CFR Regulation Number864.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-31
Decision Date2021-09-17

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