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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 K203743
Device Name EXA
Applicant
Konica Minolta Healthcare Americas, Inc.
2217 Us Highway 70 E Garner
Garner,  NC  27529
Applicant Contact Carolyn Russell
Correspondent
MEDicept, Inc
200 Homer Ave
Ashland,  MA  01721
Correspondent Contact Scott Blood
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/22/2020
Decision Date 12/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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