Cleared Traditional

ACUSON V714OR TRANSDUCER

K921341 · Acuson Corp. · Radiology
Nov 1992
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K921341 is an FDA 510(k) clearance for the ACUSON V714OR 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 November 27, 1992, 252 days after receiving the submission on March 20, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K921341 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1992
Decision Date November 27, 1992
Days to Decision 252 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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