SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2


Device Classification Name

system, image processing, radiological

510(k) Number K081469
Device Name SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2
Applicant
SECTRA IMTEC AB
1600 manchester way
corinth, 
TX 
76210

Applicant Contact carl alleto
Correspondent
SECTRA IMTEC AB
1600 manchester way
corinth, 
TX 
76210

Correspodent Contact carl alleto
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/27/2008
Decision Date 06/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No