RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0


codes

Device Classification Name

system,planning,radiation therapy treatment

510(k) Number K002240
Device Name RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
Original Applicant
PRECISION THERAPY INTL., INC.
3155 northwoods pkwy. n.w.
norcross, 
GA 
30071

Original Contact paul sumner
Regulation Number 892.5050
Classification Product Code
MUJ  
Date Received 07/24/2000
Decision Date 08/23/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No