PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM


Device Classification Name

system, radiation therapy, charged-particle, medical

510(k) Number K073059
Device Name PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
Applicant
HITACHI, LTD., POWER SYSTEMS GROUP
555 thirteenth street, nw
columbia square
washington, 
DC 
20004

Applicant Contact jonathan s kahan
Correspondent
HITACHI, LTD., POWER SYSTEMS GROUP
555 thirteenth street, nw
columbia square
washington, 
DC 
20004

Correspodent Contact jonathan s kahan
Regulation Number 892.5050
Classification Product Code
LHN  
Date Received 10/30/2007
Decision Date 12/10/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No