VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

FDA 510(k) K242893 · Luma Vision Limited

Substantially Equivalent

510(k) numberK242893

Submission

Device name
VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
Applicant
Luma Vision Limited
Dublin, IE
Received
September 23, 2024
Decision date
March 24, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OBJ – Catheter, Ultrasound, Intravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

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More from Philips Image Guided Therapy Corporation

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K261849VERAFEYE Imaging Catheter (VF-VIC-002)OBJ · Special 07/24/2026SE
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Questions and answers

When was VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System cleared by the FDA?

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (K242893) received a 510(k) decision of Substantially Equivalent on March 24, 2025, 182 days after the submission was received.

What is the product code of K242893?

The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.