HealthVCF

K192901

Zebra Medical Vision Ltd. · cleared 2020-05-12 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“HealthVCF is a passive notification for prioritization-only, parallel-workflow software tool used by clinicians to prioritize specific patients within the standard-of-care bone health setting for suspected vertebral compression fractures.”
AlgorithmArtificial intelligence algorithm
source quote (p.3)
“HealthVCF uses an artificial intelligence algorithm to analyze chest and abdominal CT scans and flags those that are suggestive of the presence of at least one vertebral compression at the exam level.”
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=611 cases

endpoints: AUC; sensitivity; specificity

Reported performance (3 observations)

sensitivity0.902CI [86.35%;93.05%]
source quote (p.9)
“The reported results for this operating point was a sensitivity of 90.20% (95% CI: [86.35%;93.05%])”
specificity0.8689CI [82.63%;90.22%]
source quote (p.9)
“and specificity was 86.89% (95% CI: [82.63%;90.22%]).”
aurocas written: “auc”0.9504CI [0.9348, 0.9660)
source quote (p.8)
“Overall, the HealthVCF was able to demonstrate an area under the curve (AUC) of 0.9504 (95% CI: [0.9348, 0.9660)”

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/K192901