ORTHOGON


Device Classification Name

system, image processing, radiological

510(k) Number K073271
Device Name ORTHOGON
Applicant
AGFA HEALTHCARE CORPORATION
10 south academy st.
greenville, 
SC 
29601

Applicant Contact tom holbrook
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 11/21/2007
Decision Date 12/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No