Cleared Special

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

K242783 · Ventana Medical Systems, Inc. · Pathology device

Dec 2024

Decision

92d

Days

Class 2

Risk

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

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on December 17, 2024, 92 days after receiving the submission on September 16, 2024.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3700. 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)..

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

Device Classification

Product Code	PSY — Whole Slide Imaging System
Device Class	Class II - 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).