.DECIMAL ELECTRON APERTURE


Device Classification Name

block, beam-shaping, radiation therapy

510(k) Number K111759
Device Name .DECIMAL ELECTRON APERTURE
Applicant
.DECIMAL, INC.
121 central park place
sanford, 
FL 
32771

Applicant Contact daniel l bennett
Correspondent
.DECIMAL, INC.
121 central park place
sanford, 
FL 
32771

Correspodent Contact daniel l bennett
Regulation Number 892.5710
Classification Product Code
IXI  
Date Received 06/22/2011
Decision Date 09/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No