# K261081: Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)

- Pathway: 510(k) (Special)
- Applicant: Beijing Konted Medical Technology Co.,Ltd
- Decided: Jul 23, 2026 after 113 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: 21 generations back to K935595 (1995). 176 ancestors in all.
No later device cites it as a predicate yet.
6 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241979: Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro), Beijing Konted Medical Technology Co.,Ltd (2024) Summary page 5.

## Indications for use
The Pocket Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B +M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes: - Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology - Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric The Pocket Ultrasound System is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Source page: https://510kreport.com/device/K261081
Methodology: https://510kreport.com/methodology