Cleared Traditional

ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

K250762 · Olympus Medical Systems Corporation · Radiology
Jul 2025
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K250762 is an FDA 510(k) clearance for the ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R), 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 July 11, 2025, 120 days after receiving the submission on March 13, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K250762 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2025
Decision Date July 11, 2025
Days to Decision 120 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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