Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K080062 |
Device Name |
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 |
Applicant |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Applicant Contact |
DOUG THISTLEWAITE |
Correspondent |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
1959 SUMMIT COMMERCE PARK |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DOUG THISTLEWAITE |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 01/09/2008 |
Decision Date | 02/11/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|