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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 K232489
Device Name VenusX
Applicant
Linatech, LLC
1294 Kifer Rd. #705
Sunnyvale,  CA  94086
Applicant Contact Jonathan Yao
Correspondent
Linatech, LLC
1294 Kifer Rd. #705
Sunnyvale,  CA  94086
Correspondent Contact Jonathan Yao
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/17/2023
Decision Date 04/12/2024
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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