HealthPNX

K190362

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

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The Zebra Pneumothorax device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment.”
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)

Standalone

n=588 cases

endpoints: stand-alone detection accuracy

Reader study (MRMC)

n=588 cases

endpoints: triage effectiveness; reduction of triage time

Reported performance (3 observations)

sensitivity0.9315CI 95% CI: [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.”
specificity0.9299CI 95% CI: [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”0.983CI 95% CI: [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%]), which is substantially equivalent to the predicate device, and meets the required performance goal for QFM product code.”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K190362