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Wireless Probe Type Ultrasound Scanner - BProbe)

by Guangzhou Sonostar Technologies Co., Ltd.

510(k) K172750

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) K172750↗

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 NumberK172750 Date28 Feb 2018ClearedStatusActive
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  • Withdrawn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
IYO
Models / Variants
BProbe)
Device Class
Class II
Regulation
21 CFR Part 892.1560
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 (Models: UProbe-C, UProbe-L, BProbe) is a wireless handheld ultrasound imaging device designed for diagnostic radiology applications. It operates as a portable, probe-based scanner that transmits ultrasound images wirelessly to a compatible display system, enabling real-time imaging without the need for physical cable connections.

These devices are intended for single-use or reusable settings, depending on the model, and are regulated under FDA 510(k) clearance (K172750) and EU MDR compliance. Supplied in sterile or non-sterile configurations as specified, they are classified under product code IYO and are intended for use in radiology environments. Storage and handling follow manufacturer guidelines to maintain performance and safety.

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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.

  • Are these wireless ultrasound scanners designed for sterile procedures, and if so, which models qualify?

    The Wireless Probe Type Ultrasound Scanner (UProbe-C, UProbe-L, and BProbe) can be supplied in either sterile or non-sterile configurations, depending on the specific use case. Sterility is explicitly mentioned as an option in the device description, so you should confirm with the manufacturer which models are available in sterile packaging for your application. This is particularly relevant for invasive or high-risk radiology procedures.

  • How do I determine whether the device is intended for single-use or reusable applications?

    The device description explicitly states these scanners are designed for *either* single-use *or* reusable settings, depending on the model. Since the data does not specify which model is single-use versus reusable, you must consult the manufacturer’s instructions or technical documentation for your specific model (UProbe-C, UProbe-L, or BProbe) to confirm reprocessing guidelines. Reusable models would require proper cleaning and sterilization per manufacturer protocols.

  • What types of radiology environments are these devices approved for, and how does that affect their use?

    The device is classified under FDA product code IYO and regulated under the Radiology advisory committee (RA), with a clearance type of *Abbreviated*. This indicates it is intended for diagnostic radiology applications, including general imaging tasks where wireless, portable ultrasound is beneficial. The EU MDR compliance also aligns with radiology use cases, but specific clinical indications (e.g., cardiac, musculoskeletal) would require further clarification from the manufacturer.

  • Do these scanners require a wired connection to a display, or are they fully standalone?

    The device is explicitly described as a *wireless* handheld ultrasound scanner that transmits images wirelessly to a compatible display system. This means no physical cable connections are needed between the probe and the display, making it highly portable for real-time imaging in radiology settings. However, the display system itself must be compatible with the wireless transmission protocol used by the scanner.

  • What should I consider when storing these devices to ensure they remain functional and safe?

    The manufacturer guidelines for storage and handling are referenced in the device description, though specific details (e.g., temperature ranges, humidity limits) are not provided. For wireless devices, you should avoid exposure to electromagnetic interference, physical damage, or moisture. If the device is reusable, follow reprocessing protocols to prevent contamination. Always refer to the included user manual or manufacturer’s instructions for precise storage requirements, especially if the device is stored long-term or between uses.