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

Pulmonary Hypertension Machine Learning-Based Notification Software

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

SAT is the FDA product code for Pulmonary Hypertension Machine Learning-Based Notification Software, a class II device type, regulated under 21 CFR 870.2380. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SAT
Device name
Pulmonary Hypertension Machine Learning-Based Notification Software
FDA definition
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.
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
3
Ingested recalls
0

Clearances, product code SAT

By decision year
3 clearances under product code SAT with a decision year between 2024 and 2026, 2026 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SAT by decision year
YearClearances
20241
20262

Applicants with the most clearances

Product code SAT
Applicants holding the most 510(k) clearances under product code SAT
ApplicantClearances
Analytics for Life Inc.1
Anumana Inc.1
Tempus AI, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code