KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K073670
Device Name KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
Applicant
OREX COMPUTED RADIOGRAPHY LTD
star yokneam bldg
p.o. box 505
yokneam, 

IL

20692

Applicant Contact dan laor
Correspondent
OREX COMPUTED RADIOGRAPHY LTD
star yokneam bldg
p.o. box 505
yokneam, 

IL

20692

Correspodent Contact dan laor
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 12/27/2007
Decision Date 01/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No