Class Class II

S90 Exp Series Digital Color Doppler Ultrasound System (K222596)

K222596 2023-02-10 Traditional
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Description

S90 Exp Series Digital Color Doppler Ultrasound System by Sonoscape Medical Corp., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222596
Clearance Date2023-02-10
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550

Categories

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Predicate lineage for K222596

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. S90 Exp Series Digital Color Doppler Ultrasound System (K222596) cites 3 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.2021
K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasoun...Sonoscape Medical Corp.2020
K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.2017

Later devices that cite this one as their predicate

Devices that cite K222596
K numberDeviceApplicantYear
K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.2025

Trace the full predicate network for K222596

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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