KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM


Device Classification Name

system, image processing, radiological

510(k) Number K023772
Device Name KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Original Applicant
ACUSON CORP.
1230 shorebird way
mountain view, 
CA 
94043

Original Contact bob leiker
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 11/12/2002
Decision Date 11/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls