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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 K241713
Device Name HiRise (1040-230)
Applicant
Curvebeam, LLC
2800 Bronze Dr. Suite #110
Suite 110
Hatfield,  PA  19440
Applicant Contact Ryan Conlon
Correspondent
Curvebeam, LLC
2800 Bronze Dr. Suite #110
Suite 110
Hatfield,  PA  19440
Correspondent Contact Ryan Conlon
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/14/2024
Decision Date 07/12/2024
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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