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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K250381
Device Name Deepsight NeedleVue LC1 Ultrasound System
Applicant
DeepSight Technology, Inc.
2953 Bunker Hill Ln.
Santa Clara,  CA  95054
Applicant Contact David Surber
Correspondent
DeepSight Technology, Inc.
2953 Bunker Hill Ln.
Santa Clara,  CA  95054
Correspondent Contact David Surber
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received02/11/2025
Decision Date 08/01/2025
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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