Roche Digital Pathology Dx— 510(k) K242783

Name: FDA 510(k) clearance K242783
Creator: U.S. Food and Drug Administration
Published: 2024-12-17

Substantially Equivalent

Ventana Medical Systems, Inc.

FDA 510(k) clearance K242783 for Roche Digital Pathology Dx, Substantially Equivalent on 2024-12-17. Applicant: Ventana Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ventana Medical Systems, Inc.
Product code: Code PSY
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2024-09-16
Decision date: 2024-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.