Cardiovascular · 510(k) · 2026
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, Inc.. Cleared by FDA on 28 March 2026 under submission K252360, product code SAT (pulmonary hypertension machine learning-based notification software). What FDA's record says, in FDA's words.
Device record · K252360
- Device. ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)DEVICE
- Company. Anumana, Inc.COMPANY
- Decision. 28 March 2026, 510(k), substantially equivalent (traditional review); received 29 July 2025DECISION
- Panel. CardiovascularPANEL
- Product code. SAT, Pulmonary Hypertension Machine Learning-Based Notification SoftwareCODE
- Regulation. 21 CFR 870.2380, Class IIREG
- Source. FDA database entry · decision document (15 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 PH 12-Lead algorithm is software intended to aid in earlier detection of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension, in adults presenting with dyspnea. ECG-AI PH 12-Lead algorithm is not intended to be a stand-alone diagnostic device for pulmonary hypertension or replace current clinical practice guidelines. A positive result may suggest the need for further clinical evaluation. Additionally, if the patient is at high risk for pulmonary hypertension, a negative result should not rule out additional clinical evaluation. ECG-AI PH 12-Lead algorithm should be applied jointly with clinician judgment. ECG-AI PH 12-Lead algorithm should not be used on ECGs from adults with an implanted pacemaker or on ECGs with a paced rhythm.
The product code's definition, from FDA's classification record. Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension 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 SAT. 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 SAT, 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.