Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K963186 |
Device Name |
ORTHO 8000 |
Applicant |
INNER VISION MRI LTD. |
719 CATALPA AVE. |
TEANECK,
NJ
07666
|
|
Applicant Contact |
DIANA UPTON |
Correspondent |
INNER VISION MRI LTD. |
719 CATALPA AVE. |
TEANECK,
NJ
07666
|
|
Correspondent Contact |
DIANA UPTON |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 08/14/1996 |
Decision Date | 11/12/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|