Cleared Special

K242783 - Roche Digital Pathology Dx (FDA 510(k) Clearance)

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

K242783 · Ventana Medical Systems, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
92d
Days
Class 2
Risk

K242783 is an FDA 510(k) clearance for the Roche Digital Pathology Dx. Classified as Whole Slide Imaging System (product code PSY), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on December 17, 2024 after a review of 92 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ventana Medical Systems, Inc. devices

Submission Details

510(k) Number K242783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2024
Decision Date December 17, 2024
Days to Decision 92 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
15d slower than avg
Panel avg: 77d · This submission: 92d
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 K242783.
Philips IntelliSite Pathology Solution 5.1
K243871 · Philips Medical Systems Nederland B.V. · Mar 2025
E1000 Dx Digital Pathology Solution
K241717 · Shandon Diagnostics Limited · Feb 2025
Philips IntelliSite Pathology Solution 5.1
K242848 · Philips Medical Systems Nederland B.V. · Dec 2024
Philips IntelliSite Pathology Solution
K241871 · Philips Medical Systems Nederland B.V. · Dec 2024
Philips IntelliSite Pathology Solution 5.1
K233204 · Philips Medical Systems Nederland B.V. · Jun 2024
Roche Digital Pathology Dx (VENTANA DP 200)
K232879 · Ventana Medical Systems, Inc. · Jun 2024