Cleared Special

CSV12 SOFTWARE VIEWER

K022896 · Acuson Corp. · Radiology

Oct 2002

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K022896 is an FDA 510(k) clearance for the CSV12 SOFTWARE VIEWER, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on October 3, 2002, 30 days after receiving the submission on September 3, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K022896 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2002
Decision Date	October 03, 2002
Days to Decision	30 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF