HealthPNX

K190362

Zebra Medical Vision Ltd. · cleared 2019-05-06 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Zebra's HealthPNX is a radiological computer-assisted triage and notification software system.”

Algorithmartificial intelligence algorithm

source quote (p.3)

“HealthPNX analyzes cases using an artificial intelligence algorithm to identify suspected findings.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=588 cases

endpoints: stand-alone detection accuracy

Reader study (MRMC)

n=588 cases

endpoints: triage effectiveness; triage time reduction

Reported performance (3 observations)

sensitivity93.15CI [87.76%, 96.67%]

source quote (p.8)

“The sensitivity and specificity of the HealthPNX was 93.15% (95% CI: [87.76%, 96.67%]) and 92.99% (95% CI: [90.19%, 95.19%])(n=588), respectively.”

specificity92.99CI [90.19%, 95.19%]

source quote (p.8)

“The sensitivity and specificity of the HealthPNX was 93.15% (95% CI: [87.76%, 96.67%]) and 92.99% (95% CI: [90.19%, 95.19%])(n=588), respectively.”

aurocas written: “auc”98.3CI [97.40%, 99.02%]

source quote (p.8)

“Overall, the HealthPNX was able to demonstrate an area under the curve (AUC) of 98.3% (95% CI: [97.40%, 99.02%])”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).