Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K153547 |
Device Name |
ECHELON Oval V 5.1 MRI System |
Applicant |
Hitachi Medical Systems America, Inc. |
1959 Summit Commerce Park |
Twinsburg,
OH
44087
|
|
Applicant Contact |
Doug Thistlethwaite |
Correspondent |
Hitachi Medical Systems America, Inc. |
1959 Summit Commerce Park |
Twinsburg,
OH
44087
|
|
Correspondent Contact |
Doug Thistlethwaite |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 12/11/2015 |
Decision Date | 03/31/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|