OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K073310
Device Name OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
Applicant
HITACHI MEDICAL CORP.
1959 summit commerce park
twinsburg, 
OH 
44087

Applicant Contact doug thistlewaite
Correspondent
HITACHI MEDICAL CORP.
1959 summit commerce park
twinsburg, 
OH 
44087

Correspodent Contact doug thistlewaite
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 11/23/2007
Decision Date 01/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No