T3 Platform Software
by Etiometry, Inc. EUDAMED510(k) 4 variants
Active
510(k) K213230
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK213230 | Date22 Jun 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- PPW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2200
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The T3 Platform Software is classified as an Adjunctive Cardiovascular Status Indicator (OpenFDA: 870.2200) and functions as a digital tool designed to provide real-time monitoring and analysis of cardiovascular parameters. It supports clinical decision-making by generating insights from physiological data, aiding in the assessment of patient status within cardiovascular care settings.
This software is supplied as a digital platform, intended for use in clinical environments where cardiovascular monitoring is required. It operates as a reusable, non-sterile device, with no specific MRI safety restrictions noted. Authorized under FDA 510K (K213230) and MDR, the T3 Platform Software is regulated under the Cardiovascular advisory committee classification and falls under Device Class II (OpenFDA). No single-use or sterility requirements are specified.
Other devices from Etiometry Inc.
Questions
AI-generated answers, 18 Sep 2026
What clinical setting is the T3 Platform Software designed for and how does it assist clinicians?
The T3 Platform Software is designed for use in clinical environments where cardiovascular monitoring is essential, such as intensive care units, emergency departments, or cardiac care units. It functions as a digital tool that provides real-time monitoring and analysis of cardiovascular parameters, generating insights to support clinical decision-making and help assess patient status during cardiovascular care.
Is the T3 Platform Software intended for single-use or reusable applications, and does it require sterilization?
The T3 Platform Software is explicitly described as a reusable, non-sterile digital platform. Since it operates as software rather than a physical device requiring direct patient contact, there are no sterility requirements or single-use constraints specified for its use.
What regulatory pathways has the T3 Platform Software undergone, and what classification does it fall under?
The T3 Platform Software has been authorized through the FDA 510K pathway (K213230) and the EU’s Medical Device Regulation (MDR). It is classified as an Adjunctive Cardiovascular Status Indicator under OpenFDA’s category 870.2200 and falls within Device Class II, regulated under the Cardiovascular advisory committee.
Are there any restrictions on using the T3 Platform Software in environments with MRI equipment?
The T3 Platform Software does not have any specified MRI safety restrictions mentioned in its documentation. Since it is a digital platform and not a physical device, it is unlikely to be affected by MRI environments, but users should confirm compatibility with their specific MRI systems if direct integration is planned.
How is the T3 Platform Software supplied, and what form does it take?
The T3 Platform Software is supplied as a digital platform, meaning it is not a physical product but rather a software solution intended for installation on clinical computing systems. It is not packaged in a sterile or disposable format, as it is reusable and non-sterile by design.