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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K250911
Device Name MOSkin Radiation Measurement System
Applicant
Electrogenics Labs, Ltd.
Suite 1, Level 10
76 Berry St.
North Sydney,  AU 2060
Applicant Contact David Rundell
Correspondent
Electrogenics Labs, Ltd.
Suite 1, Level 10
76 Berry St.
North Sydney,  AU 2060
Correspondent Contact Grant Palmer
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
NZT  
Date Received03/26/2025
Decision Date 10/17/2025
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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