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Portable ultrasound imaging system · ST-027

A battery-powered handheld ultrasound imaging system for acquiring, displaying and analysing ultrasound information. Refer to the certificate for configurations and scope.

Project record

Case reference
ST-027
Target market
Australia
Product class
MD Class IIa
Our team's work
Submitted on behalf of clients
Evidence basis
Retained certificate, 1 page

What similar projects should consider

Probes, display configuration, supporting software and intended use must match application documentation. Portability alone does not determine classification.

Individual products still require assessment of intended use, model scope and technical documentation. This case does not replace product-specific classification.

Certificate preview

Grey areas conceal manufacturer and client information. The document below contains all pages with text and images redacted.

Open the complete redacted certificate (PDF · 1 page)Portable ultrasound imaging system · ST-027: redacted certificate first page

Discuss your product registration project

Provide intended use, existing authorizations and launch plans so we can assess preparation and support needs.