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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K992352
Device Name ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
Applicant
Inteleradiology, Inc.
2400 Lorain Rd.
San Marino,  CA  91108
Applicant Contact MICHAEL VINCENT KLEIN
Correspondent
Inteleradiology, Inc.
2400 Lorain Rd.
San Marino,  CA  91108
Correspondent Contact MICHAEL VINCENT KLEIN
Regulation Number892.2020
Classification Product Code
LMD  
Date Received07/14/1999
Decision Date 09/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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