# K242681: NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)

- Pathway: 510(k) (Traditional)
- Applicant: Nurodata, Inc.
- Decided: Feb 20, 2025 after 167 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: 23 generations back to K935595 (1995). 216 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222365: Leltek Ultrasound Imaging System (Model: LU700 Series), Leltek, Inc. (2022) Summary page 6.

## Most influential descendants
- K252709: Wireless Probe Type Ultrasound Scanner (2026), 0 descendants of its own

## Indications for use
The NUSONO Handheld Ultrasound Scanner is a portable and software-based ultrasound imaging system, indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: NUSONO-C35 Fetal, Abdominal, Pediatric, Urology, Gynecology, Lung NUSONO-L75 Pediatric, Small Organ (Thyroid, Prostate, Scrotum, Breast), Musculoskeletal (Superficial and Conventional), Peripheral Vessel, Others (Carotid), Lung NUSONO-P25 Fetal, Abdominal, Pediatric, Urology, Gynecology, Cardiac (adult and pediatric), Lung The system provides diagnostic ultrasound imaging in B mode, M mode, Color Doppler mode, Power Doppler mode and combine mode (B+M, B+CD, B+PD), intended for use in environments where healthcare is provided by trained healthcare professionals. The environments where the system can be used include physician offices, clinics, hospitals, and clinical point of care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.

Source page: https://510kreport.com/device/K242681
Methodology: https://510kreport.com/methodology