SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE

Device Classification Name

system, image processing, radiological

510(k) Number K034059
Device Name SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE
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 12/31/2003
Decision Date 03/09/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No