Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K051315 |
Device Name |
MODIFICATION TO: SECTRA IDS5 WORKSTATION |
Applicant |
SECTRA IMTEC AB |
1600 MANCHESTER WAY |
CORINTH,
TX
76210
|
|
Applicant Contact |
CARL ALLETTO |
Correspondent |
SECTRA IMTEC AB |
1600 MANCHESTER WAY |
CORINTH,
TX
76210
|
|
Correspondent Contact |
CARL ALLETTO |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/20/2005 |
Decision Date | 06/15/2005 |
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
|
|
|