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SBQClass II

Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

21 CFR 870.2380 / Cardiovascular
FDA source (opens on fda.gov)

SBQ is the FDA product code for Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software, a class II device type, regulated under 21 CFR 870.2380. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SBQ
Device name
Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
FDA 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.
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SBQ

By decision year
2 clearances under product code SBQ with a decision year between 2024 and 2026, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SBQ by decision year
YearClearances
20241
20261

Applicants with the most clearances

Product code SBQ
Applicants holding the most 510(k) clearances under product code SBQ
ApplicantClearances
Tempus AI, Inc.1
TEMPUS AI, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code