Class Class II

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System (K240704)

K240704 2024-07-22 Traditional
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Description

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

Regulatory Information

Device ClassClass Class II
510(k) NumberK240704
Clearance Date2024-07-22
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550

Categories

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Predicate lineage for K240704

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 Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System (K240704) 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
K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2024
K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia...Siemens Medical Solutions USA, Inc.2023
K233270AcuNav Crystal Ultrasound CatheterSiemens Medical Solutions USA, Inc.2023

Later devices that cite this one as their predicate

Devices that cite K240704
K numberDeviceApplicantYear
K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia...Siemens Medical Solutions USA, Inc.2024

Trace the full predicate network for K240704

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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