Class Class II

MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System (K241432)

K241432 2024-09-12 Traditional
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Description

MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241432
Clearance Date2024-09-12
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550

Categories

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Predicate lineage for K241432

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. MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System (K241432) cites 3 predicate devices and is itself cited by 2 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8...Shenzhen Mindray Bio-Medical Electr...2024
K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M1...Shenzhen Mindray Bio-Medical Electr...2023
K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vau...Shenzhen Mindray Bio-Medical Electr...2021

Later devices that cite this one as their predicate

Devices that cite K241432
K numberDeviceApplicantYear
K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound S...Shenzhen Mindray Bio-Medical Electr...2025
K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound S...Shenzhen Mindray Bio-Medical Electr...2025

Trace the full predicate network for K241432

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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