Cleared Traditional

K111914 - VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K111914 is an FDA 510(k) clearance for the VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM. Classified as Automated Digital Image Manual Interpretation Microscope (product code OEO), Class II - Special Controls.

Submitted by Olympus America Inc. / Scientific Equipment Group (Center Valley, US). The FDA issued a Cleared decision on August 21, 2012 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

View all Olympus America Inc. / Scientific Equipment Group devices

Submission Details

510(k) Number K111914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
335d slower than avg
Panel avg: 77d · This submission: 412d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OEO Automated Digital Image Manual Interpretation Microscope
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.