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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 K232339
Device Name Augmented Reality Application
Applicant
Sira Medical, Inc.
14 Stanford Heights Avenue
San Francisco,  CA  94127
Applicant Contact Rick Beberman
Correspondent
MEDIcept. INC,
200 Homer Avenue
Ashland,  MA  01721
Correspondent Contact Richelle Helman
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/04/2023
Decision Date 02/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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