K261081
- 510(k) number
- K261081
- Device name
- Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
- Applicant
- Beijing Konted Medical Technology Co.,Ltd CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-07-23
- Date received
- 2026-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261081.pdf
Official FDA record: K261081
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.