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FDA 510(k)

Philips IntelliSite Pathology Solution 5.1

K-Number: K243871 · 2025-03-06

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2025-03-06
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Philips IntelliSite Pathology Solution 5.1 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2025-03-06 under 510(k) number K243871. 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 5.1?

Philips IntelliSite Pathology Solution 5.1 is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K243871.

When did Philips IntelliSite Pathology Solution 5.1 receive FDA 510(k) clearance?

Philips IntelliSite Pathology Solution 5.1 received FDA 510(k) clearance on 2025-03-06, under 510(k) number K243871.

Who is the listed applicant for Philips IntelliSite Pathology Solution 5.1?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips IntelliSite Pathology Solution 5.1?

The FDA product code for Philips IntelliSite Pathology Solution 5.1 is PSY.

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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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