Cleared Traditional

SURGICAL MICROSCOPE SYSTEM ORBEYE with IR (K190772) - FDA 510(k) Clearance

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

K190772 · Olympus Medical Systems Corp. · Neurology device
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Oct 2019
Decision
198d
Days
Class 2
Risk

K190772 is an FDA 510(k) clearance for the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 10, 2019 after a review of 198 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 892.1600 - the FDA neurology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K190772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2019
Decision Date October 10, 2019
Days to Decision 198 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 148d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 Neurology devices follow this clearance model.

Regulatory Consultant

Olympus Corporation of the Americas
Sheri L. Musgnung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZI System, X-ray, Angiographic

All 198
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