IDS5 IMAGE DISPLAY SYSTEM


Device Classification Name

system, image processing, radiological

510(k) Number K001140
Device Name IDS5 IMAGE DISPLAY SYSTEM
Original Applicant
SECTRA AB
2001 east oakshores dr.
crossroads, 
TX 
76227

Original Contact herman oosterwijk
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/10/2000
Decision Date 05/03/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No