BRACHYSEED PD-103 MODELS #PD1


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K011119
Device Name BRACHYSEED PD-103 MODELS #PD1
Original Applicant
DRAXIMAGE, INC.
16751 trans canada highway
kirkland, qc, 

CA

h9h 4j4

Original Contact richard j flanagan
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 04/12/2001
Decision Date 06/25/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Abbreviated
Reviewed by Third Party No

Combination Product

No