Devices · Tempus AI, Inc.

Tempus ECG-AF

Tempus AI, Inc. is listed for Tempus ECG-AF (K233549). The FDA list gives June 21, 2024 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SBQ as “Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233549

Official FDA database record

Date of final decision

June 21, 2024

Company on the FDA list

Tempus AI, Inc.

Lead panel

Cardiovascular

Primary product code

SBQ

openFDA device name for the code

Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

Device class

2

Regulation number

870.2380

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary