Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K211406 |
Device Name |
OASIS MRI System |
Applicant |
Hitachi Healthcare Americas |
1959 Summit Commerce Park |
Twinsburg,
OH
44087
|
|
Applicant Contact |
Aaron Pierce |
Correspondent |
FUJIFILM Healthcare Americas Corporation |
1959 Summit Commerce Park |
Twinsburg,
OH
44087
|
|
Correspondent Contact |
Aaron Pierce |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 05/06/2021 |
Decision Date | 10/07/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|