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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K002240
Device Name RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
Applicant
Precision Therapy Intl., Inc.
3155 Northwoods Pkwy. NW
Norcross,  GA  30071
Applicant Contact PAUL SUMNER
Correspondent
Precision Therapy Intl., Inc.
3155 Northwoods Pkwy. NW
Norcross,  GA  30071
Correspondent Contact PAUL SUMNER
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/24/2000
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
Predetermined Change
Control Plan Authorized		 No
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