# K172750: Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)

- Pathway: 510(k) (Abbreviated)
- Applicant: Guangzhou Sonostar Technologies Co., Ltd.
- Decided: Feb 28, 2018 after 169 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K935595 (1995). 102 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151339: SONON Ultrasound Imaging System (Model: SONON 300C), Healcerion Co., Ltd. (2015) Summary page 8.
- K100598: Penrith Elettra Ultrasound System, Penrith Corporation (2010) Summary page 8.
- K130229: Palm Bladder Scanner, Mianyang Meike Electronic Equipment Co., Ltd. (2013) Summary page 8.

## Most influential descendants
- K211321: Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) (2022), 1 descendant of its own
- K260111: Palmtop Ultrasound Diagnostic System (MT10P/MT10) (2026), 0 descendants of its own
- K220169: SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) (2022), 0 descendants of its own
- K213488: Bladder Scanner, Model Name:M5 (2022), 0 descendants of its own

## Indications for use
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) (frequency: 3.5Hz, module: convex) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) (frequency: 7.5Hz, module: linear) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging. The Wireless Probe Type Ultrasound Scanner (Model: BProbe) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.

Source page: https://510kreport.com/device/K172750
Methodology: https://510kreport.com/methodology