# K211321: Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)

- Pathway: 510(k) (Abbreviated)
- Applicant: Guangzhou Sonostar Technologies Co., Ltd.
- Decided: Oct 13, 2022 after 531 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K935595 (1995). 103 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172750: Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe), Guangzhou Sonostar Technologies Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- K260111: Palmtop Ultrasound Diagnostic System (MT10P/MT10) (2026), 0 descendants of its own

## Indications for use
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) 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 part of this device that is intended to contact with the patient is the probe head. Modes of operation: • Pulsed-echo ultrasound • Mode B (2D) scan • Mode BM scan • Doppler mode (COLOR) • Energy Doppler mode (PDI) • Pulse Doppler (PW) Operator qualifications: The operator should be capable to understand the Instructions for Use; The operator must be an appropriately-trained healthcare professional or used under the supervision of the authority of a physician. Device use settings: hospital or home use.

Source page: https://510kreport.com/device/K211321
Methodology: https://510kreport.com/methodology