Cleared Traditional

ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP

K902515 · Acuson Corp. · Radiology
Sep 1992
Decision
822d
Days
Class 2
Risk

About This 510(k) Submission

K902515 is an FDA 510(k) clearance for the ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP, 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 September 4, 1992, 822 days after receiving the submission on June 5, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K902515 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1990
Decision Date September 04, 1992
Days to Decision 822 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

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

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