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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, Mobile
510(k) Number K181874
Device Name MX40 Mobile Digital X-ray System
Applicant
Huestis Machine Corporation
68 Buttonwood St.
Bristol,  RI  02809
Applicant Contact Frederick M. Correira
Correspondent
Huestis Machine Corporation
68 Buttonwood St.
Bristol,  RI  02809
Correspondent Contact Frederick M. Correira
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received07/13/2018
Decision Date 09/14/2018
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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