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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Computed Tomography, Cone-Beam
510(k) Number K260510
Device Name VenusCT
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 Number892.1750
Classification Product Code
SFV  
Date Received02/17/2026
Decision Date 10/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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