510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QYEClass II

Reduced Ejection Fraction Machine Learning-Based Notification Software

21 CFR 870.2380 / Cardiovascular
FDA source (opens on fda.gov)

QYE is the FDA product code for Reduced Ejection Fraction Machine Learning-Based Notification Software, a class II device type, regulated under 21 CFR 870.2380. FDA's definition for this code reads: "Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QYE
Device name
Reduced Ejection Fraction Machine Learning-Based Notification Software
FDA definition
Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up.
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code QYE

By decision year
5 clearances under product code QYE with a decision year between 2023 and 2025, 2025 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code QYE by decision year
YearClearances
20231
20241
20253

Applicants with the most clearances

Product code QYE
Applicants holding the most 510(k) clearances under product code QYE
ApplicantClearances
Anumana Inc.2
Bunkerhill Health1
Eko Health, Inc.1
TEMPUS AI, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code