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
|
|
Correspondent Contact |
CARL ALLETO |
Regulation Number | 892.2050
|
Classification Product Code |
|
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
|
|
|