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Wireless Probe Type Ultrasound Scanner - Type: Type C, Type L, Type CT, Type CL)

by Guangzhou Sonostar Technologies Co., Ltd.

510(k) K211321

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211321↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK211321 Date13 Oct 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
IYN
Models / Variants
Type: Type C, Type L, Type CT, Type CL)
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Wireless Probe Type Ultrasound Scanner CProbe is a handheld diagnostic imaging device classified as a wireless ultrasound probe system. It integrates ultrasound imaging, power management, and wireless signal transmission to facilitate real-time diagnostic echo imaging, measurements, and analysis of human tissues and organs.

This device is designed for use in clinical settings, connecting wirelessly to a main unit for image processing and display. Available in multiple probe types (C, L, CT, CL), it is intended for single-use or reusable applications, depending on the model variant, and complies with FDA 510(k) clearance (K211321) and MDR requirements. Storage and handling follow manufacturer guidelines to maintain performance and sterility.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of ultrasound probes are included in the CProbe Wireless Probe Type Ultrasound Scanner, and how do they differ in use?

    The CProbe Wireless Probe Type Ultrasound Scanner comes in four probe types: Type C, Type L, Type CT, and Type CL. These variations are designed for different clinical applications—Type C and L are likely optimized for general imaging tasks, while Type CT and CL may offer specialized features like compound imaging or linear arrays for more precise tissue evaluation. The choice depends on the anatomical region and imaging requirements, such as superficial or deeper tissue assessment.

  • Is the CProbe Wireless Probe Type Ultrasound Scanner intended for single-use or reusable applications, and how should it be handled?

    The CProbe can be used either as a single-use or reusable device, depending on the specific model variant. For reusable applications, strict adherence to manufacturer guidelines for cleaning, disinfection, and storage is required to maintain performance and sterility. Single-use variants should be discarded after one use to ensure patient safety and device integrity. Always follow the manufacturer’s instructions for proper handling and reprocessing.

  • How does the CProbe Wireless Probe Type Ultrasound Scanner connect to the main imaging system, and what are its key features for real-time imaging?

    The CProbe connects wirelessly to a main imaging unit, eliminating the need for cables and enabling greater mobility during clinical use. It integrates ultrasound imaging, power management, and wireless signal transmission to provide real-time diagnostic capabilities, including echo imaging, measurements, and tissue/organ analysis. This design allows clinicians to focus on patient assessment without the constraints of wired probes.

  • What regulatory pathways has the CProbe Wireless Probe Type Ultrasound Scanner followed, and which advisory committee was involved in its review?

    The CProbe has undergone FDA 510(k) clearance (K211321) and complies with MDR (Medical Device Regulation) requirements. Its review was conducted under the Radiology advisory committee (RA), specifically the Radiology (RA) panel, which evaluates devices classified under product code IYN. This pathway confirms its substantial equivalence to a predicate device and ensures compliance with safety and performance standards.