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Diagnostic imaging

ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System is cataloged as an AI-enabled diagnostic imaging product associated with radiology workflows. Source records identify Siemens Medical Solutions USA, Inc. as the associated developer or manufacturer.

Designed for

Radiologist and clinical team

Care setting

Imaging department and relevant care setting

Specialty

Radiology

Catalog record · evidence not yet assessedCatalog updated 2026-08-31

Catalog status

Evidence not yet characterized

This catalog entry is based on 3 public source records. RIR has not yet characterized the product's clinical evidence.

This is a catalog and scoping record. RIR has not completed a public-evidence assessment of this product. Inclusion is not endorsement, verification, certification, or a recommendation.

What the source record supports

The linked sources support catalog inclusion and identify the product and associated organization. They do not constitute an RIR evidence assessment.

What still needs verification

Current product-family mapping, exact intended use and version, present availability, independent performance, subgroup behavior, workflow effects, safety monitoring, and patient outcomes may remain unresolved.

Product facts

Working intended-use description
Support radiologist and clinical team in imaging department and relevant care setting within the source-described diagnostic imaging workflow.
Intended-use status
Inferred from category/workflow metadata — do not publish as verified
Represented version
Public sources accessed 2026-08-31; represented software version not established
Regulatory context
FDA's AI-Enabled Medical Device List contains 3 records for this candidate (K251481, K242523, K240704); the latest listed decision date is 2025-08-20. Product-family mapping, current marketing status, and the exact authorized scope require decision-record review.

Sources represented

3 source records used to identify or scope this catalog entry.

FDA authorization record K251481RegulatoryFDA authorization record K242523RegulatoryFDA authorization record K240704Regulatory
For clinical and investment reviewEvidence context and questions for deeper review

Current source base

This catalog entry is based on 3 public source records. RIR has not yet characterized the product's clinical evidence.

Important limitation

Current product-family mapping, exact intended use and version, present availability, independent performance, subgroup behavior, workflow effects, safety monitoring, and patient outcomes may remain unresolved.

Questions to ask

  1. 01How does performance vary across sites, scanners, protocols, and patient subgroups?
  2. 02What are the clinically consequential false-positive and false-negative rates?
  3. 03How are performance drift, overrides, and product updates monitored after deployment?
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