Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K133986 |
Device Name |
1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY |
Applicant |
RESONANCE INNOVATIONS LLC |
9840 S 140th St Ste 8 |
OMAHA,
NE
68138
|
|
Applicant Contact |
RANDALL JONES |
Correspondent |
RESONANCE INNOVATIONS LLC |
9840 S 140th St Ste 8 |
OMAHA,
NE
68138
|
|
Correspondent Contact |
RANDALL JONES |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 12/26/2013 |
Decision Date | 01/27/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|