Cleared Traditional

ACUSON V714 TRANSDUCER

K920882 · Acuson Corp. · Radiology
Mar 1993
Decision
394d
Days
Class 2
Risk

About This 510(k) Submission

K920882 is an FDA 510(k) clearance for the ACUSON V714 TRANSDUCER, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on March 26, 1993, 394 days after receiving the submission on February 26, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K920882 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1992
Decision Date March 26, 1993
Days to Decision 394 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

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

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