510(k) K241871

Device
Philips IntelliSite Pathology Solution
Applicant
Philips Medical Systems Nederland B.V.
510(k) number
K241871
Product code
PSY
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-02
Date received
2024-06-27
Regulation
864.3700
Classification name
Whole Slide Imaging System
Medical specialty
Pathology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Donna Peled
Address
Veenpluis 6 Best NL 5684PC 5684PC

FDA Registration Numbers

Source Documents

510(k) summary PDF

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