Skip to content

Vision 2, EVARVision, TrackVision 2, HeartVision 2

by GE Medical Systems SCS France EUDAMED510(k)

510(k) K223152 Product code LLZ

Overview

The Vision 2, EVARVision, TrackVision 2, and HeartVision 2 are intravascular ultrasound (IVUS) imaging systems designed for real-time visualization of blood vessels and cardiac structures. These devices provide high-resolution cross-sectional images to assess vascular anatomy, plaque composition, and stent deployment during interventional procedures.

Supplied by GE Medical Systems SCS, these systems are intended for use in clinical settings such as catheterization labs and cardiac catheterization suites. They are classified under product code LLZ and have received FDA 510(k) clearance and MDR authorization. The devices are not described as single-use or reusable in the provided data, though their regulatory status confirms compliance with applicable safety and performance standards.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK223152 Date22 Nov 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from GE Medical Systems SCS

See all devices from GE Medical Systems SCS →

Questions

  • What types of medical procedures can the Vision 2, EVARVision, TrackVision 2, and HeartVision 2 intravascular ultrasound systems be used for?

    These systems are designed for real-time visualization of blood vessels and cardiac structures during interventional procedures. Specifically, they provide high-resolution cross-sectional imaging to assess vascular anatomy, plaque composition, and stent deployment. Clinicians can use them in catheterization labs and cardiac catheterization suites to guide interventions like peripheral artery evaluations, coronary artery assessments, and stent placements.

  • Are these devices intended for single-use or can they be reused? The provided data doesn’t specify, but what should buyers consider when evaluating their usage?

    The data does not explicitly state whether the Vision 2, EVARVision, TrackVision 2, and HeartVision 2 systems are single-use or reusable. However, intravascular ultrasound (IVUS) systems are typically designed for repeated use in clinical settings, provided they undergo proper cleaning, disinfection, and maintenance per manufacturer guidelines. Buyers should confirm with GE Medical Systems SCS regarding their specific reuse protocols and maintenance requirements to ensure compliance with safety and performance standards.

  • What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?

    The Vision 2, EVARVision, TrackVision 2, and HeartVision 2 systems have received FDA 510(k) clearance and MDR authorization, confirming they meet applicable safety and performance standards. This regulatory approval ensures they can be legally marketed and used in clinical settings like catheterization labs and cardiac suites, where they support procedures requiring detailed visualization of blood vessels and cardiac structures. The clearance also indicates they are deemed substantially equivalent to a predicate device, reinforcing their reliability for interventional procedures.

  • How are these devices supplied, and what should clinicians or facilities expect when integrating them into their workflow?

    The Vision 2, EVARVision, TrackVision 2, and HeartVision 2 are supplied by GE Medical Systems SCS as part of an intravascular ultrasound imaging system. Facilities should expect a comprehensive setup that includes imaging hardware, catheters, and software for real-time visualization. Integration into existing workflows may require training for staff, as these systems are intended for use in specialized areas like catheterization labs. Buyers should confirm the exact components included in their order and any additional accessories or consumables required for operation.

Properties & raw data

Show properties, registry sources and raw records

Sources (2)

  • FDA 510(k) K223152 24 fields · synced 22 Oct 2026
  • EUDAMED 1 fields · synced 19 May 2026