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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, Tomography, Computed
510(k) Number K203187
Device Name HiRise
Applicant
Curvebeam, LLC
2800 Bronze Dr., Suite 110
Hatfield,  PA  19044
Applicant Contact Ryan Conlon
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/27/2020
Decision Date 11/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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