HealthCXR
K192320Zebra Medical Vision, Ltd. · cleared 2019-11-26 · product code QFM · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“The Zebra HealthCXR device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pleural effusion in the medical care environment.”
Algorithmartificial intelligence algorithm
source quote (p.3)
“HealthCXR 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 (1)
Retrospective clinical
n=554 cases
endpoints: AUC; sensitivity; specificity
Reported performance (3 observations)
sensitivity0.9674CI [92.79; 96.48]
source quote (p.8)
“The first operating point showed a sensitivity of 96.74% (95% CI: [92.79; 96.48])”
specificity0.9317CI [89.57; 95.58]
source quote (p.8)
“and a specificity of 93.17% (95% CI: [89.57; 95.58]).”
aurocas written: “auc”0.9885CI [0.9815, 0.9956]
source quote (p.8)
“Overall, the HealthCXR was able to demonstrate an area under the curve (AUC) of 0.9885 (95% CI: [0.9815, 0.9956])”
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). 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).