FDA.report

510(k) K253714

Device
IntraSight Plus
Applicant
Philips Image Guided Therapy Corporation
510(k) number
K253714
Product code
IYO
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-24
Date received
2025-11-24
Regulation
892.1560
Classification name
System, Imaging, Pulsed Echo, Ultrasonic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Jeff Rongero
Address
9965 Federal Dr. Colorado Springs CO US 80921 80921

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code IYO

510(k)DeviceApplicantDecision date
K252237EdgeFlow UW20Edgecare, Inc.2026-04-17
K254021Accuro XVRivanna Medical, Inc.2026-04-09
K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.2026-03-04
K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited2026-02-06
K250331Astrasono A3Pro Bladder Scanner (A3Pro)Astrasono Technology Co., Ltd.2025-09-30
K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.2025-08-01
K243227B-ScanAccutome, Inc. Doing Business AS Keeler USA2025-07-11
K251728Velacur One (LI-1100)Sonic Incytes Medical Corp2025-06-26
K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)Wuxi Hisky Medical Technologies Co., Ltd.2025-06-17
K243937Accuro 3SRivanna Medical, Inc.2025-05-23
K243479EchoGuide (Version 1)Sonavex, Inc.2025-04-23
K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited2024-11-19
K241029SpineUs™ SystemVerdure Imaging2024-10-07
K233977VelacurSonic Incytes2024-09-04
K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.2024-06-26