Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K061916 |
Device Name |
NEURO II-SE, MODELS OR-MB-DR AND OR-DR |
Applicant |
IMRIS, INC. |
16809 BRIARDALE ROAD |
ROCKVILLE,
MD
20855
|
|
Applicant Contact |
THOMAS M TSAKERIS |
Correspondent |
IMRIS, INC. |
16809 BRIARDALE ROAD |
ROCKVILLE,
MD
20855
|
|
Correspondent Contact |
THOMAS M TSAKERIS |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 07/06/2006 |
Decision Date | 08/11/2006 |
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
|
|
|