ScreenDx
K241891Imvaria, Inc · cleared 2025-01-10 · product code QWO · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“ScreenDx is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to assess for interstitial lung findings compatible with interstitial lung disease.”
source quote (p.6)
“The Analysis System is composed of a 3-D deep learning algorithm trained to identify interstitial lung findings compatible with interstitial lung disease.”
source quote (p.6)
“The algorithm takes in the ingested CT scan, runs it through the locked model, and classifies whether interstitial lung findings compatible with interstitial lung disease appear to be present.”
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Validation studies (2)
Retrospective clinical
n=3,018 cases
endpoints: software's performance in CT chest cases containing interstitial lung findings compatible with interstitial lung disease versus those without such patterns; 80% sensitivity; 80% specificity
standards: IEC 62304
Prospective clinical
n=2,482 cases
endpoints: ability to identify positive cases in a low prevalence population
Reported performance (6 observations)
source quote (p.14)
“Specifically, sensitivity was observed to be 91.4% (89.0 - 93.3%)”
source quote (p.14)
“and specificity was observed to be 95.2% (CI: 94.3 - 96.1%).”
source quote (p.14)
“PPV 85.1% [CI: 82.3-87.6%]”
source quote (p.14)
“NPV 97.4% [CI: 96.6-98.0%]”
source quote (p.16)
“Device Sensitivity 87% [CI: 85.8-88.5%]”
source quote (p.16)
“Device Specificity 98% [CI: 97.5-98.5%]”
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).