Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)

K-Number: K253801 · 2026-04-07

ApplicantAnumana, Inc.
Decision Date2026-04-07
Product CodeSHP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is the device name listed in this FDA 510(k) record. The listed applicant is Anumana, Inc.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K253801. The device is classified under product code SHP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)?

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Anumana, Inc.. The 510(k) number is K253801.

When did ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) receive FDA 510(k) clearance?

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) received FDA 510(k) clearance on 2026-04-07, under 510(k) number K253801.

Who is the listed applicant for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)?

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

What is the FDA product code for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)?

The FDA product code for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is SHP.

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.

NCT05298553Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac ArrhythmiasCOMPLETEDNCT05873387Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic StethoscopeRECRUITINGNCT06271577Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction IIRECRUITINGNCT06589700B2AD-Risk AFDAS Evolution of Burden of AFRECRUITINGNCT06878768Translational Research GRICS-CineCardiacCOMPLETEDNCT07087613Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECGRECRUITING

Other records listing Anumana, 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.

K260300WatchMate SoftwareK252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)K233160NeuTrace EP Mapping System v.2.1K232699Low Ejection Fraction AI-ECG Algorithm

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.

↑