DeviceClearance

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)— 510(k) K252360

Substantially Equivalent

Anumana, Inc.

FDA 510(k) clearance K252360 for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020), Substantially Equivalent on 2026-03-28. Applicant: Anumana, Inc.. Device class: 2.

Summary

Anumana's ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) is filed under SAT, pulmonary hypertension machine learning-based notification software. The record doesn't describe the algorithm beyond its name and that code name.

Class II, 21 CFR 870.2380. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).

Anumana filed from Cambridge, Massachusetts. The decision came 242 calendar days after receipt (July 29, 2025 to March 28, 2026).

Clearance details

Applicant
Anumana, Inc.
Product code
Product code SAT
Device class
Class 2
Regulation
21 CFR 870.2380
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cambridge, MA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code SAT

view all

More clearances from Anumana, Inc.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.