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T3 Platform Software

by Etiometry, Inc. 4 variants

510(k) K202306

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202306 Date25 Nov 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The T3 Platform Software is a clinical intelligence software system designed for intensive care units (ICUs), serving as an end-to-end solution for data management. It aggregates, analyzes, visualizes, and archives critical patient data to support real-time clinical decision-making and care escalation or de-escalation.

This software is intended for use in high-acuity care settings and is supplied as a regulated medical device with FDA 510(k) clearance under the Traditional pathway (K202306, Product Code MWI). It operates as a reusable digital platform, requiring no physical sterilization, and is intended for integration within existing ICU workflows without MRI compatibility constraints.

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