Class Class II

NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) (K242681)

K242681 2025-02-20 Traditional
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Description

NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) by Nurodata, Inc., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242681
Clearance Date2025-02-20
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550

Categories

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Predicate lineage for K242681

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) (K242681) cites 4 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.2022
K191235Leltek Ultrasound Imaging SystemLeltek, Inc.2020
K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.2019
K121983DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-...Benq Medical Technology Corpation2012

Trace the full predicate network for K242681

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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