Cleared Traditional

Tempus ECG-AF

K233549 · Tempus AI, Inc. · Cardiovascular
Jun 2024
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K233549 is an FDA 510(k) clearance for the Tempus ECG-AF, a Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software (Class II — Special Controls, product code SBQ), submitted by Tempus AI, Inc. (Chicago, US). The FDA issued a Cleared decision on June 21, 2024, 231 days after receiving the submission on November 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2380.

Submission Details

510(k) Number K233549 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2023
Decision Date June 21, 2024
Days to Decision 231 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code SBQ — Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2380
Definition Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Future Occurrence Of Atrial Fibrillation For Further Referral Or Diagnostic Follow-up.