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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 K232189
Device Name OrionXR
Applicant
Hoth Intelligence Inc.
1700 Market Street Unit 1005
Philadelphia,  PA  19103
Applicant Contact Jonathan Cohen
Correspondent
Hogan Lovells US LLP
1735 Martket Street, Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Kelliann H. Payne
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/24/2023
Decision Date 09/14/2023
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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