Cleared Traditional

K933663 - MODIFICATION OF ACUSON V510B TRANSDUCER
(FDA 510(k) Clearance)

K933663 · Acuson Corp. · Radiology

Jan 1994

Decision

177d

Days

Class 2

Risk

K933663 is an FDA 510(k) clearance for the MODIFICATION OF ACUSON V510B 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 January 21, 1994, 177 days after receiving the submission on July 28, 1993.

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

Submission Details

510(k) Number	K933663 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 1993
Decision Date	January 21, 1994
Days to Decision	177 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF