ERGO++ VERSION 1.7


Device Classification Name

system,planning,radiation therapy treatment

510(k) Number K080601
Device Name ERGO++ VERSION 1.7
Applicant
3D LINE MEDICAL SYSTEMS S.R.L.
4775 peachtree industrial blvd
bldg 300, suite 300
norcross, 
GA 
30092

Applicant Contact thomas valentine
Correspondent
3D LINE MEDICAL SYSTEMS S.R.L.
4775 peachtree industrial blvd
bldg 300, suite 300
norcross, 
GA 
30092

Correspodent Contact thomas valentine
Regulation Number 892.5050
Classification Product Code
MUJ  
Date Received 03/03/2008
Decision Date 06/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls