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 Philips Medical Systems Nederland B.V. and Ventana Medical Systems, Inc..

6
Total
6
Cleared
293d
Avg days
2007
Since

FDA 510(k) Cleared Automated Digital Image Manual Interpretation Microscope Devices (Product Code OEO)

6 devices
1–6 of 6
Cleared Jul 16, 2015
Virtuoso System for IHC PR (1E2) using iScan HT
K142965
Ventana Medical Systems, Inc.
Pathology · 275d
Cleared Sep 19, 2013
PHILIPS HERCEPTEST DIGITAL SCORE
K130021
Philips Medical Systems Nederland B.V.
Pathology · 259d

About Product Code OEO - Regulatory Context