Cleared Traditional

K921670 - ACUSON IMAGE MANAGEMENT SYSTEM
(FDA 510(k) Clearance)

K921670 · Acuson Corp. · Radiology

Jun 1992

Decision

78d

Days

Class 2

Risk

K921670 is an FDA 510(k) clearance for the ACUSON IMAGE MANAGEMENT SYSTEM. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO).

Submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on June 25, 1992, 78 days after receiving the submission on April 8, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K921670 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 1992
Decision Date	June 25, 1992
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement