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Philips IntelliSite Pathology Solution

DEN160056 Class II Direct
Decision Date
2017-04-12
Sponsor / Applicant
Philips Medical Systems Nederland B.V.

Technical Specification

510(k) Submission ID DEN160056
Product Code PSY
Medical Specialty / Panel Pathology
Regulation Citation 21 CFR 864.3700
Decision Date 2017-04-12
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Philips IntelliSite Pathology Solution received FDA 510(k) clearance under submission number DEN160056, sponsored by Philips Medical Systems Nederland B.V.. The device was reviewed via the Direct premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2017-04-12.

Classification & Regulation

This clearance is catalogued under FDA product code PSY and 21 CFR 864.3700, within the Pathology review panel as a Class II device.