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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Image Processing, Radiological
510(k) Number K925465
Device Name TELERADIOLOGY DEVICE & COMPONENT OF PACS COMPONENT
Applicant
Life Care Imaging
235 W. Main St.
Cary,  IL  60013
Applicant Contact ALAN I BECKER
Correspondent
Life Care Imaging
235 W. Main St.
Cary,  IL  60013
Correspondent Contact ALAN I BECKER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/29/1992
Decision Date 01/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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