Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K120701 |
Device Name |
M2 WRIST MRI SYSTEM |
Applicant |
ASPECT IMAGING LTD |
20 HATA'AS ST |
(OPB 124) |
KFAR SABA,
IL
44425
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
ASPECT IMAGING LTD |
20 HATA'AS ST |
(OPB 124) |
KFAR SABA,
IL
44425
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 03/07/2012 |
Decision Date | 02/07/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|