Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K170978 |
Device Name |
Embrace Neonatal MRI System |
Applicant |
Aspect Imaging Ltd. |
27 Shaked St. |
Industrial Area Hevel Modi’in.,
IL
6085001
|
|
Applicant Contact |
Israel Citron |
Correspondent |
Aspect Imaging Ltd. |
27 Shaked Street |
Industrial Area, Hevel Modi'in, P.O. Box 926 |
Shoham,
IL
6085001
|
|
Correspondent Contact |
Israel Citron |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/03/2017 |
Decision Date | 07/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|