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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 K231396
Device Name CEPHX- Cephalometric Analysis Software
Applicant
Orca Dental AI LTD
10 Hamanofim Street
Herzliya,  IL PO 4672561
Applicant Contact Daniel Abraham
Correspondent
Orca Dental AI LTD
10 Hamanofim Street
Herzliya,  IL PO 4672561
Correspondent Contact Daniel Abraham
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/15/2023
Decision Date 01/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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