Cleared Special

Philips IntelliSite Pathology Solution (K192259) - FDA 510(k) Clearance

Class II Pathology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192259 · Philips Electronics Nederland B.V. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
30d
Days
Class 2
Risk

K192259 is an FDA 510(k) clearance for the Philips IntelliSite Pathology Solution. Classified as Whole Slide Imaging System (product code PSY), Class II - Special Controls.

Submitted by Philips Electronics Nederland B.V. (Best, NL). The FDA issued a Cleared decision on September 20, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - the FDA pathology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Philips Electronics Nederland B.V. devices

Submission Details

510(k) Number K192259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2019
Decision Date September 20, 2019
Days to Decision 30 days
Submission Type Special
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 77d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PSY Whole Slide Imaging System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3700
Definition The Whole Slide Imaging System Is An Automated Digital Slide Creation, Viewing, And Management System Intended As An Aid To The Pathologist To Review And Interpret Digital Images Of Surgical Pathology Slides Prepared From Formalin-fixed, Paraffin-embedded (ffpe) Tissue. The System Generates Digital Images That Would Otherwise Be Appropriate For Manual Visualization By Conventional Brightfield Microscopy. The Whole Slide Imaging System Is Not Intended For Use With Slides Prepared From Frozen Tissue, Cytology, And Non-ffpe Hematopathology Specimens (e.g., Peripheral Blood Smear).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - PSY Whole Slide Imaging System

All 18
Devices cleared under the same product code (PSY) and FDA review panel - the closest regulatory comparables to K192259.
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