Cleared Traditional

K023772 - KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
(FDA 510(k) Clearance)

K023772 · Acuson Corp. · Radiology
Nov 2002
Decision
10d
Days
Class 2
Risk

K023772 is an FDA 510(k) clearance for the KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Acuson Corp. (Mountainview, US). The FDA issued a Cleared decision on November 22, 2002, 10 days after receiving the submission on November 12, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K023772 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2002
Decision Date November 22, 2002
Days to Decision 10 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050