Cleared Traditional

VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM

K111914 · Olympus America Inc. / Scientific Equipment Group · Pathology
Aug 2012
Decision
412d
Days
Class 2
Risk

About This 510(k) Submission

K111914 is an FDA 510(k) clearance for the VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM, a Automated Digital Image Manual Interpretation Microscope (Class II — Special Controls, product code OEO), submitted by Olympus America Inc. / Scientific Equipment Group (Center Valley, US). The FDA issued a Cleared decision on August 21, 2012, 412 days after receiving the submission on July 6, 2011. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K111914 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2011
Decision Date August 21, 2012
Days to Decision 412 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.