AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0


Device Classification Name

system, image processing, radiological

510(k) Number K022970
Device Name AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0
Original Applicant
AMICAS, INC.
20 guest st.
brighton, 
MA 
02135

Original Contact patrice nedelec
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/06/2002
Decision Date 11/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No