Cardiovascular · 510(k) · 2026
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
Anumana, Inc.. Cleared by FDA on 7 April 2026 under submission K253801, product code SHP (cardiac amyloidosis machine learning-based notification software). What FDA's record says, in FDA's words.
Device record · K253801
- Device. ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)DEVICE
- Company. Anumana, Inc.COMPANY
- Decision. 7 April 2026, 510(k), substantially equivalent (traditional review); received 28 November 2025DECISION
- Panel. CardiovascularPANEL
- Product code. SHP, Cardiac Amyloidosis Machine Learning-Based Notification SoftwareCODE
- Regulation. 21 CFR 870.2380, Class IIREG
- Source. FDA database entry · decision document (12 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.
The ECG-AI Cardiac Amyloidosis 12-Lead Algorithm is software as a medical device intended to aid in earlier detection of Cardiac Amyloidosis in adults being evaluated for signs or symptoms consistent with cardiac amyloidosis. This population includes patients that have at least one condition commonly associated with cardiac amyloidosis, such as: unexplained heart failure, nephrotic syndrome, peripheral neuropathy, arrhythmias, or aortic stenosis. The ECG-AI Cardiac Amyloidosis 12-Lead Algorithm is not intended to be a stand-alone diagnostic device for cardiac amyloidosis nor to replace current clinical practice guidelines. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of Cardiac Amyloidosis. Additionally, if the patient is at high risk for the cardiac condition, a negative result should not rule out additional clinical evaluation. The ECG-AI Cardiac Amyloidosis 12-Lead algorithm should be applied jointly with clinician judgment.
The product code's definition, from FDA's classification record. Cardiac Amyloidosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac amyloidosis 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
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SHP. 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 SHP, in Cardiovascular, from Anumana, Inc., or cleared in 2026. 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.