IDS4 V3.2 IMAGE DISPLAY SYSTEM


Device Classification Name

system, image processing, radiological

510(k) Number K991643
Device Name IDS4 V3.2 IMAGE DISPLAY SYSTEM
Applicant
OTECH, INC.
2001 east oakshores dr.
crossroads, 
TX 
76227

Applicant Contact herman oosterwijk
Correspondent
OTECH, INC.
2001 east oakshores dr.
crossroads, 
TX 
76227

Correspodent Contact herman oosterwijk
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/13/1999
Decision Date 06/08/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No