510(k) K261081

Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) by Beijing Konted Medical Technology Co.,Ltd — Product Code IYN

K261081 is an FDA 510(k) premarket notification submitted by Beijing Konted Medical Technology Co.,Ltd for the device "Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)". The FDA issued a decision of Substantially Equivalent on July 23, 2026. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Beijing Konted Medical Technology Co.,Ltd has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2026
Date Received
April 1, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type