HealthICH
K190424Zebra Medical Vision Ltd. · cleared 2019-06-13 · product code QAS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“Zebra's HealthICH solution is a software product that automatically identifies suspected finding suggestive of Intracranial Hemorrhage and notifies the PACS/workstation of the presence of this critical finding in the scan.”
Algorithmartificial intelligence algorithm
source quote (p.5)
“Zebra's HealthICH Triage Device uses an artificial intelligence algorithm to analyze CT scans.”
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=427 cases
endpoints: detection accuracy; triage effectiveness; per-case processing time
Reported performance (2 observations)
sensitivity94.47CI 90.32-97.21%
source quote (p.8)
“HealthICH sensitivity and specificity of 94.47% (95% CI: 90.32-97.21%)”
specificity92.54CI 88.33-95.60%
source quote (p.8)
“and 92.54% (95% CI: 88.33-95.60%)”
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).