PROTON BEAM THERAPY SYSTEM (PBTS)


Device Classification Name

system, radiation therapy, charged-particle, medical

510(k) Number K992414
Device Name PROTON BEAM THERAPY SYSTEM (PBTS)
Applicant
OPTIVUS TECHNOLOGY, INC.
49 plain st.
north attleboro, 
MA 
02760

Applicant Contact renee j thibeault
Correspondent
OPTIVUS TECHNOLOGY, INC.
49 plain st.
north attleboro, 
MA 
02760

Correspodent Contact renee j thibeault
Regulation Number 892.5050
Classification Product Code
LHN  
Date Received 07/20/1999
Decision Date 07/21/2000
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Radiology

510k Review Panel

Radiology
summary

summary

Type Traditional
Reviewed by Third Party No
Combination Product

No