Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K090080 |
Device Name |
CIRRUS OPEN |
Applicant |
MRI-TECH SP. ZO.O. |
206 - 3820 CAMBIE STREET |
vancouver, bc,
CA
v5z 2x7
|
|
Applicant Contact |
anita chan |
Correspondent |
MRI-TECH SP. ZO.O. |
206 - 3820 CAMBIE STREET |
vancouver, bc,
CA
v5z 2x7
|
|
Correspondent Contact |
anita chan |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 01/12/2009 |
Decision Date | 03/23/2009 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|