TLC PEDIATRIC FRAME, MODEL TLC-SYS


Device Classification Name

accelerator, linear, medical

510(k) Number K991523
Device Name TLC PEDIATRIC FRAME, MODEL TLC-SYS
Applicant
RADIONICS, INC.
22 terry ave.
burlington, 
MA 
01803 -2516

Applicant Contact nancy c macdonald
Correspondent
RADIONICS, INC.
22 terry ave.
burlington, 
MA 
01803 -2516

Correspodent Contact nancy c macdonald
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 05/03/1999
Decision Date 07/30/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No