Cleared Traditional

K043275 - OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULT...

K043275 is the FDA 510(k) clearance for OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULT... by Olympus Medical Systems Corporation. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K043275 · Olympus Medical Systems Corporation · Radiology device
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Dec 2004
Decision
13d
Days
Class 2
Risk

K043275 is an FDA 510(k) clearance for the OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Melville, US). The FDA issued a Cleared decision on December 9, 2004 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K043275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2004
Decision Date December 09, 2004
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Radiology devices follow this clearance model.

Regulatory Consultant

Entela, Inc.
NED DEVINE

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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

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