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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact DAN LAOR
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/27/2007
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
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