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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 K220684
Device Name Oryx Cloud Imaging
Applicant
Oryx Dental Software, Inc.
1001 Fairview Ave. N.
Suite 2275
Seattle,  WA  98109
Applicant Contact Rania Saleh
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/08/2022
Decision Date 04/29/2022
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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