SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1

Device Classification Name

system, image processing, radiological

510(k) Number K033088
Device Name SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1
Applicant
SECTRA AB
1100 lakeview blvd.
denton, 
TX 
76208

Applicant Contact carl alletto
Correspondent
SECTRA AB
1100 lakeview blvd.
denton, 
TX 
76208

Correspodent Contact carl alletto
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/29/2003
Decision Date 10/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls