# K242893: VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Luma Vision Limited
- Decided: Mar 24, 2025 after 182 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 30 generations back to K935595 (1995). 264 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212959: ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter, Siemens Medical Solutions USA, Inc. (2021) Summary page 5.
- K211726: Acuson SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2021) Summary page 6.

## Most influential descendants
- K261849: VERAFEYE Imaging Catheter (VF-VIC-002) (2026), 0 descendants of its own
- K260885: VERAFEYE Imaging and Guidance System (VF-VIS-002) (2026), 0 descendants of its own

## Indications for use
VERAFEYE Imaging Catheter The VERAFEYE Imaging Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. VERAFEYE Imaging System The VERAFEYE Imaging System is intended for cardiac applications. The system transmits ultrasound energy into adult patients creating 2D (B-mode), & 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system also provides the ability to indicate scale with respect to anatomical structures, which provides information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The system utilizes catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

Source page: https://510kreport.com/device/K242893
Methodology: https://510kreport.com/methodology