WORKSTATIONONE BREAST IMAGING WORKSTATION


Device Classification Name

system, image processing, radiological

510(k) Number K073272
Device Name WORKSTATIONONE BREAST IMAGING WORKSTATION
Applicant
THREE PALM SOFTWARE, LLC
367 penn way
los gatos, 
CA 
95032

Applicant Contact heidi d zhang
Correspondent
THREE PALM SOFTWARE, LLC
367 penn way
los gatos, 
CA 
95032

Correspodent Contact heidi d zhang
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 11/21/2007
Decision Date 12/11/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No