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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 a medical device manufactured by Guangzhou Sonostar Technologies Co., Ltd.. It received FDA 510(k) clearance on 2018-02-28 under approval 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. It is manufactured by Guangzhou Sonostar Technologies Co., Ltd.. The 510(k) number is K172750.

When was Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) approved by the FDA?

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

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

Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) is manufactured by Guangzhou Sonostar Technologies Co., Ltd..

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

NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07602933 Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES NOT_YET_RECRUITING NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED NCT04047784 Pilot Study to Evaluate the Role of EBUS in the Diagnosis of Acute PE in Critically Ill Patients ENROLLING_BY_INVITATION

Other Devices by Guangzhou Sonostar Technologies Co., Ltd.

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

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

Official Source

View on FDA Database →

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

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