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FDA 510(k)

Tempus ECG-MR

K-Number: K254297 · 2026-09-25

ApplicantTempus AI, Inc.
Decision Date2026-09-25
Product CodeSBQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tempus ECG-MR is the device name listed in this FDA 510(k) record. The listed applicant is Tempus AI, Inc.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K254297. The device is classified under product code SBQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tempus ECG-MR?

Tempus ECG-MR is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Tempus AI, Inc.. The 510(k) number is K254297.

When did Tempus ECG-MR receive FDA 510(k) clearance?

Tempus ECG-MR received FDA 510(k) clearance on 2026-09-25, under 510(k) number K254297.

Who is the listed applicant for Tempus ECG-MR?

The FDA 510(k) record lists Tempus AI, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tempus ECG-MR?

The FDA product code for Tempus ECG-MR is SBQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06511505NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) TrialRECRUITINGNCT06911632Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary HypertensionRECRUITING

Other records listing Tempus AI, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P210011Next generation sequencing oncology panel, somatic or germline variant detection systemK253699Tempus ECG-PHK241868xR IVDK250119Tempus ECG-Low EFK233549Tempus ECG-AF

Related Devices (Code: SBQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233549Tempus ECG-AFTempus AI, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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