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FDA 510(k)

Philips IntelliSite Pathology Solution

K-Number: K203845 · 2021-09-17

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2021-09-17
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Philips IntelliSite Pathology Solution is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2021-09-17 under approval number K203845. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Philips IntelliSite Pathology Solution?

Philips IntelliSite Pathology Solution is a medical device that received FDA 510(k) clearance on 2021-09-17. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K203845.

When was Philips IntelliSite Pathology Solution approved by the FDA?

Philips IntelliSite Pathology Solution received FDA 510(k) clearance on 2021-09-17, under approval number K203845.

What company makes Philips IntelliSite Pathology Solution?

Philips IntelliSite Pathology Solution is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Philips IntelliSite Pathology Solution?

The FDA product code for Philips IntelliSite Pathology Solution is PSY.

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Related Devices (Code: PSY)

K172174Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. DEN160056Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. K192259Philips IntelliSite Pathology SolutionPhilips Electronics Nederland B.V. K190332Aperio AT2 DX SystemLeica Biosystems Imaging, Inc. K203364MDPC-8127Barco N.V. K213883NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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