HITACHI ALTAIRE


information about

Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K002420
Device Name HITACHI ALTAIRE
Original Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 summit commerce park
twinsburg, 
OH 
44087

Original Contact douglas thistlethwaite
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 08/08/2000
Decision Date 10/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls