S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE


Device Classification Name

system, x-ray, mammographic

510(k) Number K023229
Device Name S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
Original Applicant
AMERICAN MAMMOGRAPHICS, INC.
1302 shawhan terrace
chattanooga, 
TN 
37411

Original Contact adrian palmer
Regulation Number 892.1710
Classification Product Code
IZH  
Date Received 09/27/2002
Decision Date 12/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No