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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 K203651
Device Name Cuptimize
Applicant
Cuptimize, Inc.
2840 W. Bay Dr., Unit #163
Belleair Bluffs,  FL  33770
Applicant Contact Noah Wollowick
Correspondent
MCRA, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Michelle McDonough
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
HAW  
Date Received12/14/2020
Decision Date 02/26/2021
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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