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
SIKClass II

Cardiac Hypertrophy Machine Learning-Based Notification Software

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

SIK is the FDA product code for Cardiac Hypertrophy Machine Learning-Based Notification Software, a class II device type, regulated under 21 CFR 870.2380. FDA's definition for this code reads: "Cardiac hypertrophy machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac hypertrophy for further referral or diagnostic follow-up". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SIK
Device name
Cardiac Hypertrophy Machine Learning-Based Notification Software
FDA definition
Cardiac hypertrophy machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac hypertrophy 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
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code