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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 K253714
Device Name IntraSight Plus
Applicant
Philips Image Guided Therapy Corporation
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact Jeff Rongero
Correspondent
Philips Image Guided Therapy Corporation
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact Jeff Rongero
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
DSA   DSK   OWB  
Date Received11/24/2025
Decision Date 02/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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