Cleared Traditional

GYNESONICS EC6 TRANSDUCER

K061153 · Gynesonics, Inc. · Radiology
Oct 2006
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K061153 is an FDA 510(k) clearance for the GYNESONICS EC6 TRANSDUCER, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Gynesonics, Inc. (Redwood City, US). The FDA issued a Cleared decision on October 27, 2006, 184 days after receiving the submission on April 26, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K061153 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2006
Decision Date October 27, 2006
Days to Decision 184 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

Similar Devices — ITX Transducer, Ultrasonic, Diagnostic

All 408
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
K250883 · Olympus Medical Systems Corporation · Sep 2025
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
K250762 · Olympus Medical Systems Corporation · Jul 2025
Mendaera Guidance System
K250524 · Mendaera, Inc. · Jul 2025
Accuro? 3S Needle Guide Kit
K250469 · Rivanna Medical, Inc. · Jun 2025
Ultrasound Transducer Cover
K241662 · Vitrolife Sweden AB · Aug 2024
UltraDrape UGPIV Barrier and Securement (34-15)
K233965 · Parker Laboratories, Inc. · Aug 2024