Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K193116 |
Device Name |
MRopen EVO |
Applicant |
ASG Superconductors S.p.A. |
Corso Ferdinando Maria Perrone 73/R |
Genova,
IT
16152
|
|
Applicant Contact |
DeBenedetti Luisella |
Correspondent |
ASG Superconductors S.p.A. |
Corso Ferdinando Maria Perrone 73/R |
Genova,
IT
16152
|
|
Correspondent Contact |
Luisella De Benedetti |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/12/2019 |
Decision Date | 12/20/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|