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510(k) K251103

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) by Philips Image Guided Therapy Corporation — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2025
Date Received
April 11, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ultrasound, Intravascular
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

Other clearances by Philips Image Guided Therapy Corporation

  • K253714 — IntraSight Plus (February 24, 2026)
  • K200812 — VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Cathet (September 2, 2020)
  • K200410 — Reconnaissance PV .018 OTW Digital IVUS Catheter (May 22, 2020)

Other clearances for product code OBJ

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  • K250955 — XC11 ICE System, USA (October 22, 2025)
  • K250913 — TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (July 19, 2025)
  • K251211 — ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD (May 23, 2025)
  • K251231 — ViewFlex™ X ICE Catheter, Sensor Enabled™ (May 20, 2025)
  • K242893 — VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (March 24, 2025)
  • K241540 — NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (June 28, 2024)
  • K240050 — SOUNDSTAR™ CRYSTAL Ultrasound Catheter (June 12, 2024)
  • K233948 — Provisio™ SLT IVUS™ System (April 23, 2024)
  • K233270 — AcuNav Crystal Ultrasound Catheter (October 28, 2023)