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SONON 500L Ultrasound Imaging System

by Healcerion Co., Ltd. EUDAMED510(k)

Active European Union and United States

510(k) K212400

Overview

The SONON 500L is a portable handheld ultrasound imaging system designed for diagnostic imaging using a 6 to 12 MHz linear probe. It provides real-time imaging with color Doppler, pulsed-wave (PW), and M-mode capabilities, enabling detailed visualization of soft tissues and vascular structures.

This system is supplied as a reusable device with integrated workflow support, including PACS and server connectivity. It operates wirelessly with two included Li-ion batteries and a charger, ensuring continuous use without interruptions. The SONON 500L is authorized under FDA 510K clearance (K212400) and complies with the Medical Device Directive (MDD), intended for use in clinical radiology settings.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK212400 Date22 Apr 2022ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United 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 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 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 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 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States FDA 510(k) Active

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

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k)

Full name
SONON Ultrasound Imaging System, Model: SONON 500L
510(k) Number
FDA Product Code
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Healcerion Co., Ltd.

Questions

  • Is the SONON 500L designed for single-use or can it be reused in a clinical setting?

    The SONON 500L is explicitly described as a reusable device, meaning it is built for repeated use in clinical radiology settings. Since it includes features like PACS and server connectivity, as well as integrated workflow support, it is intended to be part of a long-term imaging infrastructure rather than a disposable solution.

  • What types of imaging capabilities does the SONON 500L support, and what frequency range does its linear probe cover?

    The SONON 500L provides real-time imaging with three key Doppler modes: color Doppler, pulsed-wave (PW), and M-mode. Its included linear probe operates within a 6 to 12 MHz frequency range, making it suitable for detailed visualization of soft tissues and vascular structures.

  • How is the SONON 500L powered, and what accessories are included for continuous use?

    The system operates wirelessly and includes two Li-ion batteries for extended use, along with a dedicated charger. This setup ensures uninterrupted imaging sessions without requiring wired connections or frequent battery swaps.

  • What regulatory pathways has the SONON 500L followed, and where is it authorized for use?

    The SONON 500L has undergone FDA 510(k) clearance (K212400) under the Traditional pathway, with a Substantially Equivalent determination by the Radiology (RA) Advisory Committee. It also complies with the Medical Device Directive (MDD), confirming its authorization for clinical radiology use in regions adhering to these standards.