OEO · Class II · 21 CFR 864.1860

FDA Product Code OEO: Automated Digital Image Manual Interpretation Microscope

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.

Leading manufacturers include Ventana Medical Systems, Inc..

1
Total
1
Cleared
275d
Avg days
2015
Since

List of Automated Digital Image Manual Interpretation Microscope devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Jul 16, 2015
Virtuoso System for IHC PR (1E2) using iScan HT
K142965
Ventana Medical Systems, Inc.
Pathology · 275d

How to use this database

This page lists all FDA 510(k) submissions for Automated Digital Image Manual Interpretation Microscope devices (product code OEO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Pathology FDA review panel. Browse all Pathology devices →