ACCULEAF


Device Classification Name

accelerator, linear, medical

510(k) Number K021338
Device Name ACCULEAF
Original Applicant
DIREX SYSTEMS CORP.
11 mercer rd.
natick, 
MA 
01760

Original Contact larisa gershtein
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 04/26/2002
Decision Date 01/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No