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

Q: What is the product code of K172750?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.

FDA 510(k) K172750 · Guangzhou Sonostar Technologies Co., Ltd.

Substantially Equivalent

510(k) numberK172750

Submission

Device name: Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)
Applicant: Guangzhou Sonostar Technologies Co., Ltd.
Guangzhou, CN
Received: September 12, 2017
Decision date: February 28, 2018
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: IYO – System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1560
Specialty: Radiology

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K243227	B-ScanIYO · Traditional	Accutome, Inc. Doing Business AS Keeler USA	07/11/2025SE

More from Accutome, Inc. Doing Business AS Keeler USA

510(k)	Device	Decision
K211321	Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…IYN · Abbreviated	10/13/2022SE
K171926	C5 Diagnostic Ultrasound SystemIYN · Traditional	10/27/2017SE

Questions and answers

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

Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) (K172750) received a 510(k) decision of Substantially Equivalent on February 28, 2018, 169 days after the submission was received.

What is the product code of K172750?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.