Cleared Traditional

ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)

K250883 · Olympus Medical Systems Corporation · Radiology
Sep 2025
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K250883 is an FDA 510(k) clearance for the ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R), a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Olympus Medical Systems Corporation (Hachioji-Shi, JP). The FDA issued a Cleared decision on September 18, 2025, 178 days after receiving the submission on March 24, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K250883 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2025
Decision Date September 18, 2025
Days to Decision 178 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code ITX — Transducer, Ultrasonic, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1570

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