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 (K251481)

K251481 2025-08-20 Traditional
Home/ Devices/ ACUSON Sequoia Diagnostic Ultrasound…

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) NumberK251481
Clearance Date2025-08-20
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550

Categories

Need More Information?

Contact the manufacturer or request a quote for this device.

Request Quote

Predicate lineage for K251481

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 (K251481) 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
K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia...Siemens Medical Solutions USA, Inc.2024

Trace the full predicate network for K251481

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.

Scroll to Top