FDA 510(k)

Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)

K-번호: K261081 · 2026-07-23

신청자Beijing Konted Medical Technology Co.,Ltd

결정일2026-07-23

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Konted Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K261081. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)?

Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Beijing Konted Medical Technology Co.,Ltd. The 510(k) number is K261081.

When did Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) receive FDA 510(k) clearance?

Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) received FDA 510(k) clearance on 2026-07-23, under 510(k) number K261081.

Who is the listed applicant for Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)?

The FDA 510(k) record lists Beijing Konted Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)?

The FDA product code for Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) is IYN.

Beijing Konted Medical Technology Co.,Ltd를 신청인으로 등재한 기타 기록

K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)K231354Pocket Ultrasound System (C10)

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