Class Class II

ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System (K230207)

K230207 2023-02-13 Traditional
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Description

ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System by Siemens Medical Solutions USA, Inc., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230207
Clearance Date2023-02-13
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550

Categories

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Predicate lineage for K230207

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. ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System (K230207) 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
K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juni...Siemens Medical Solutions USA, Inc.2022
K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.2022
K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers2019

Later devices that cite this one as their predicate

Devices that cite K230207
K numberDeviceApplicantYear
K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia...Siemens Medical Solutions USA, Inc.2024
K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Sel...Siemens Medical Solutions USA, Inc.2023

Trace the full predicate network for K230207

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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