CT Cardiomegaly
K232613Innolitics, LLC · cleared 2024-02-28 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The CT Cardiomegaly application is a software only (SaMD) medical device which includes automated algorithms and non-adaptive machine learning to analyze chest computed tomography (CT) images.”
source quote (p.11)
“Machine learning based algorithm (non-adaptive)”
source quote (p.6)
“CT Cardiomegaly is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR from an axial CT slice containing the heart using a non-adaptive machine learning algorithm.”
Validation studies (1)
Retrospective clinical
n=275 cases
endpoints: calculating the difference between the average measurement of the human readers and the subject device's measurement; precision of selecting the slice where the heart area is the largest (key heart slice detection); accuracy of heart and inner chest segmentations
Reported performance (2 observations)
source quote (p.13)
“0.95 [0.950, 0.956]”
source quote (p.13)
“0.98 [0.982, 0.984]”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).