510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253801Substantially Equivalent

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

Anumana Inc., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253801 is the FDA 510(k) clearance record for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040), a class II device, cleared for Anumana, Inc. on under FDA product code SHP (Cardiac Amyloidosis Machine Learning-Based Notification Software). FDA's definition for product code SHP reads: "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". FDA records list 6 510(k) clearances for Anumana, Inc., from to . As of , FDA records show no recalls naming K253801.

Clearance record

Decision date
Received
(130 days to decision)
Product code
SHP Cardiac Amyloidosis Machine Learning-Based Notification Software
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Applicant
Anumana, Inc. One Main St., Suite 400, Cambridge MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SHP

Trailing 12 months
1 clearance under product code SHP in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260