P3IMRT TM


Device Classification Name

system,planning,radiation therapy treatment

510(k) Number K002237
Device Name P3IMRT TM
Original Applicant
ADAC LABORATORIES
540 alder dr.
milpitas, 
CA 
95035

Original Contact janice e brown
Regulation Number 892.5050
Classification Product Code
MUJ  
Date Received 07/24/2000
Decision Date 02/02/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No