T3 Platform Software

No FDA recalls on record, checked 6 Oct 2026.

Trade Name

T3 Platform software EUDAMED

T3 Risk Analytics Platform GUDID

Generic Name

Clinical decision management support software

Device Name

Etiometry Platform Software

Model / Reference

DAV 5.4 RAE 10.0 EUDAMED

2 GUDID

Primary DI / UDI-DI

00863061000309

Basic UDI-DI

08630610003D000R0006W

Direct Marketing DI

00863061000309

510(k) Number

K223578 ↗

FDA Product Code

PPW, PLB

EMDN Code

V92 Medical device software - not included in other classes

GMDN Term

Clinical decision management support software

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 870.2200 510(k)GUDID

870.2300 GUDID

Special Device Type

Software

Market of Registration

Denmark

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• T3 Platform Software 2

  Class II

  GUDID on market

• Etiometry Platform 2

  Class II

  GUDID on market

• Etiometry Platform

  Class II

  FDA 510(k) K254066 Active Cleared 3 Apr 2026

• T3 Software

  Class II

  FDA 510(k) K163065 Active Cleared 26 May 2017

• T3 Platform software

  Class II

  FDA 510(k) K190273 Active Cleared 8 Dec 2019

• Etiometry Platform (DAV 5.4 RAE 9.2)

  Class II

  FDA 510(k) K241479 Active Cleared 12 Feb 2025

See all devices from Etiometry Inc. →

• What types of clinical settings is the T3 Platform Software designed for, and how does it integrate with existing systems?

  The T3 Platform Software is specifically designed for clinical settings such as hospitals and cardiovascular care units. It functions as a digital tool that connects to compatible medical devices and systems, providing real-time analysis and visualization of cardiovascular health metrics to support clinical decision-making. Since it operates via authorized connections, it is intended to augment traditional diagnostic methods rather than replace them.

• Is the T3 Platform Software reusable or single-use, and how is it supplied?

  The T3 Platform Software is neither single-use nor reusable, as it is a digital platform rather than a physical device. It is supplied as software that runs on authorized systems and connects to compatible medical devices, requiring no physical packaging or sterility considerations. The software’s functionality relies on its ongoing digital operation and integration with existing healthcare infrastructure.

• What regulatory approvals does the T3 Platform Software hold, and what does this mean for its use in clinical practice?

  The T3 Platform Software holds FDA 510K clearance and MDR authorization, confirming it meets regulatory standards for use as an adjunctive cardiovascular status indicator. This classification under Device Class II indicates it has undergone evaluation for safety and effectiveness, allowing clinicians to rely on its real-time data analysis as a supplementary tool in cardiovascular care. The approvals ensure compliance with both U.S. and European regulatory frameworks.

• How does the T3 Platform Software differ from traditional cardiovascular diagnostic tools, and what specific metrics does it assess?

  Unlike traditional diagnostic tools that rely solely on physical measurements or imaging, the T3 Platform Software provides a digital, real-time assessment of cardiovascular health metrics. While the exact metrics aren’t detailed in the data, its purpose is to offer additional insights beyond conventional methods—such as heart rate variability, hemodynamic trends, or other cardiovascular parameters—by analyzing data from connected devices. This aids clinicians in making more informed decisions about patient status.

• What should clinicians consider when implementing the T3 Platform Software in their facility, particularly regarding compatibility and maintenance?

  Clinicians should verify that their facility’s existing medical devices and systems are compatible with the T3 Platform Software, as it relies on authorized connections for data analysis. Since it is a software-based solution, maintenance typically involves software updates and ensuring secure, HIPAA-compliant network access. The platform’s integration with cardiovascular care units suggests it is intended for use alongside—not instead of—established diagnostic equipment, so compatibility testing with specific devices may be necessary before deployment.