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FDA 510(k)

Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)

K-Number: K172750 · 2018-02-28

ApplicantGuangzhou Sonostar Technologies Co., Ltd.
Decision Date2018-02-28
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Sonostar Technologies Co., Ltd.. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K172750. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)?

Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Guangzhou Sonostar Technologies Co., Ltd.. The 510(k) number is K172750.

When did Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) receive FDA 510(k) clearance?

Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) received FDA 510(k) clearance on 2018-02-28, under 510(k) number K172750.

Who is the listed applicant for Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)?

The FDA 510(k) record lists Guangzhou Sonostar Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)?

The FDA product code for Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) is IYO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Guangzhou Sonostar Technologies Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)K171926C5 Diagnostic Ultrasound System

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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