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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K041580
Device Name IMAGERAYI
Applicant
Henry Schein, Inc.
11661 San Vicente Blvd.
Los Angeles,  CA  90049
Applicant Contact W. EDWARD JOHANSEN
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact W. EDWARD JOHANSEN
Regulation Number872.1800
Classification Product Code
MUH  
Date Received06/14/2004
Decision Date 06/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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