DeviceClearance

Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)— 510(k) K261081

Substantially Equivalent

Beijing Konted Medical Technology Co.,Ltd

FDA 510(k) clearance K261081 for Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro), Substantially Equivalent on 2026-07-23. Applicant: Beijing Konted Medical Technology Co.,Ltd. Device class: 2.

Summary

Beijing Konted Medical Technology's Pocket Ultrasound System comes in five models (C10MTpro, C10MXpro, C10MSpro, C10MBpro, and C10MRpro), filed under IYN, pulsed Doppler ultrasonic imaging systems. The record doesn't say how they differ.

Class II, 21 CFR 892.1550. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).

Beijing Konted filed from Beijing, China. The decision came 113 calendar days after receipt (April 1 to July 23, 2026).

Clearance details

Applicant
Beijing Konted Medical Technology Co.,Ltd
Product code
Product code IYN
Device class
Class 2
Regulation
21 CFR 892.1550
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Beijing, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IYN

product code IYN
Death
25
Injury
163
Malfunction
1,538
Other
4
Total
1,730

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.