Cleared Traditional

K911916 - ACUSON C366 TRANSDUCER
(FDA 510(k) Clearance)

K911916 · Acuson Corp. · Radiology

Jun 1992

Decision

415d

Days

Class 2

Risk

K911916 is an FDA 510(k) clearance for the ACUSON C366 TRANSDUCER. This device is classified as 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 June 18, 1992, 415 days after receiving the submission on April 30, 1991.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number	K911916 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 1991
Decision Date	June 18, 1992
Days to Decision	415 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement