Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K982994 |
Device Name |
SKULL BASE INSTATRAK SYSTEM |
Applicant |
VISUALIZATION TECHNOLOGY, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760 -4153
|
|
Applicant Contact |
MARY MCNAMARA-CULLINANE |
Correspondent |
VISUALIZATION TECHNOLOGY, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760 -4153
|
|
Correspondent Contact |
MARY MCNAMARA-CULLINANE |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/27/1998 |
Decision Date | 11/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|