VeriSight Intracardiac Echocardiography Catheter (VSICE2D) +1 more model

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251103

by Philips Image Guided Therapy Corporation

Identifiers

510(k) Number: K251103 FDA 510(k)
FDA Product Code: OBJ FDA 510(k)
Models / Variants: VeriSight Intracardiac Echocardiography Catheter (VSICE2D) FDA 510(k)
VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.1200 FDA 510(k)
Regulation Number: 870.1200 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

VeriSight Intracardiac Echocardiography Catheter (VSICE2D) +1 more model by Philips Image Guided Therapy Corporation — Class II — FDA_510K — listed in FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K251103	Class II	Active

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Manufacturer

Manufacturer: Philips Image Guided Therapy Corporation

Sources (1)

FDA 510(k) K251103 24 fields · synced Jun 18, 2026