Cardiovascular · 510(k) · 2024
Tempus ECG-AF
Tempus AI, Inc.. Cleared by FDA on 21 June 2024 under submission K233549, product code SBQ (atrial fibrillation risk prediction machine learning-based notification software). What FDA's record says, in FDA's words.
Device record · K233549
- Device. Tempus ECG-AFDEVICE
- Company. Tempus AI, Inc.COMPANY
- Decision. 21 June 2024, 510(k), substantially equivalent (traditional review); received 3 November 2023DECISION
- Panel. CardiovascularPANEL
- Product code. SBQ, Atrial Fibrillation Risk Prediction Machine Learning-Based Notification SoftwareCODE
- Regulation. 21 CFR 870.2380, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Tempus ECG-AF is intended for use to analyze recordings of 12-lead ECG devices and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. It is for use on resting 12-lead ECG recordings collected at a healthcare facility from patients: • 65 years of age or older, • without pre-existing or concurrent documentation of atrial fibrillation and/or atrial flutter, • who do not have a pacemaker or implantable cardioverter defibrillator, and • who did not have cardiac surgery within the preceding 30 days.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SBQ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SBQ, in Cardiovascular, from Tempus AI, Inc., or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.