SCIMAGE PICOMENTERPRISE


Device Classification Name

system, image processing, radiological

510(k) Number K073169
Device Name SCIMAGE PICOMENTERPRISE
Applicant
SCIMAGE, INC.
16303 panoramic way
san leandro, 
CA 
94578 -1116

Applicant Contact gary j allsebrook
Correspondent
SCIMAGE, INC.
16303 panoramic way
san leandro, 
CA 
94578 -1116

Correspodent Contact gary j allsebrook
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 11/09/2007
Decision Date 01/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No