OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120


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

Correspodent Contact doug thistlewaite
Regulation Number 892.1000
Classification Product Code
MOS  
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