Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K141945 |
Device Name |
ECHOSTAR COMFORT 1.5T MRI |
Applicant |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
28900 FOUNTAIN PARKWAY |
SOLON,
OH
44139
|
|
Applicant Contact |
MICHAELEEN DOM |
Correspondent |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
28900 FOUNTAIN PARKWAY |
SOLON,
OH
44139
|
|
Correspondent Contact |
MICHAELEEN DOM |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 07/17/2014 |
Decision Date | 02/03/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|