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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 K882754
Device Name REPORT AND IMAGE MANAGEMENT SYSTEM
Applicant
Medical Image Processing Specialists, Inc.
6087 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact PATRICK F LEONARD
Correspondent
Medical Image Processing Specialists, Inc.
6087 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact PATRICK F LEONARD
Regulation Number892.2020
Classification Product Code
LMD  
Date Received07/05/1988
Decision Date 10/21/1988
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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