Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K121997 |
Device Name |
IMRIS ONCOLOGY PACKAGE |
Applicant |
IMRIS, INC. |
100-1370 SONY PLACE |
WINNIPEG, MB,
CA
R3T 1N5
|
|
Applicant Contact |
Sanjay Shah |
Correspondent |
IMRIS, INC. |
100-1370 SONY PLACE |
WINNIPEG, MB,
CA
R3T 1N5
|
|
Correspondent Contact |
Sanjay Shah |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/09/2012 |
Decision Date | 08/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|