Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K203372 |
Device Name |
SyMRI |
Applicant |
SyntheticMR AB |
Storgatan 11 |
Linkoping,
SE
582 23
|
|
Applicant Contact |
Lisa Warnroth |
Correspondent |
Licensale Inc |
3422 Leonardo Lane |
New Smyrna Lane,
FL
32168
|
|
Correspondent Contact |
Raymond Kelly |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/16/2020 |
Decision Date | 11/03/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|