Cleared Traditional

Virtuoso System for IHC PR (1E2) using iScan HT

K142965 · Ventana Medical Systems, Inc. · Pathology
Jul 2015
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K142965 is an FDA 510(k) clearance for the Virtuoso System for IHC PR (1E2) using iScan HT, a Automated Digital Image Manual Interpretation Microscope (Class II — Special Controls, product code OEO), submitted by Ventana Medical Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 16, 2015, 275 days after receiving the submission on October 14, 2014. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K142965 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2014
Decision Date July 16, 2015
Days to Decision 275 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code OEO — Automated Digital Image Manual Interpretation Microscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.1860
Definition The Ihc Her2 Manual Read Of A Digital Slide Application Is Intended For Use As An Aid To The Pathologist In The Detection And Semi-quantitative Measurement Of Her2/neu (c-erbb-2) In Formalin-fixed, Paraffin-embedded Normal And Neoplastic Tissue Immunohistochemically Stained For Her-2 Receptors, Using Microscopy Images Displayed On A Computer Monitor. Her-2 Results Are Indicated For Use As An Aid In The Management, Prognosis And Prediction Of Therapy Outcomes In Breast Cancer.