Class Class II

SonoMax Series Digital Color Doppler Ultrasound System (K233697)

K233697 2024-08-09 Traditional
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Description

SonoMax Series Digital Color Doppler Ultrasound System by CHISON Medical Technologies Co., Ltd., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK233697
Clearance Date2024-08-09
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550

Categories

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Predicate lineage for K233697

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. SonoMax Series Digital Color Doppler Ultrasound System (K233697) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.2020

Trace the full predicate network for K233697

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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