Cleared Traditional

K982610 - OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ...

K982610 is an FDA 510(k) clearance for OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ..., manufactured by Olympus Optical, Co.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K982610 · Olympus Optical, Co. · Radiology device
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Nov 1998
Decision
112d
Days
Class 2
Risk

K982610 is an FDA 510(k) clearance for the OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINAR.... Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Olympus Optical, Co. (Melville, US). The FDA issued a Cleared decision on November 16, 1998 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Optical, Co. devices

FDA 510(k) Submission Details - K982610

510(k) Number K982610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date November 16, 1998
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 107d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Peers - ITX Transducer, Ultrasonic, Diagnostic

All 206
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