HealthMammo

K200905

Zebra Medical Vision Ltd. · cleared 2020-07-16 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The Zebra HealthMammo is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA-qualified interpreting physicians to prioritize patients with suspicious findings in the medical care environment.”
Algorithmartificial intelligence algorithm
source quote (p.3)
“HealthMammo utilizes an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding 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=835 images

endpoints: AUC; sensitivity; specificity

standards: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Reported performance (7 observations)

sensitivity89.89CI [86.69%;92.38%]
source quote (p.9)
“The first operating point, “standard mode,” reported a sensitivity of 89.89% (95% CI: [86.69%;92.38%]) and a specificity of 90.75% (95% CI: [87.51%;93.21%]).”
specificity90.75CI [87.51%;93.21%]
source quote (p.9)
“The first operating point, “standard mode,” reported a sensitivity of 89.89% (95% CI: [86.69%;92.38%]) and a specificity of 90.75% (95% CI: [87.51%;93.21%]).”
aurocas written: “auc”0.9661CI [0.9552, 0.9769]
source quote (p.9)
“Overall, the HealthMammo was able to demonstrate an area under the ROC curve (AUC) of 0.9661 (95% CI: [0.9552, 0.9769]), which is comparable with the predicate device, and exceeds the required technical method under the QFM product code for effective triage with an AUC >95%.”
sensitivityas written: “Sensitivity (high sensitivity mode)”94.02CI [91.39%;95.89%]
source quote (p.9)
“The second operating point, “high sensitivity” reported a sensitivity of 94.02% (95% CI: [91.39%;95.89%]) and a specificity of 83.50% (95% CI: [79.55%;86.82%]).”
specificityas written: “Specificity (high sensitivity mode)”83.5CI [79.55%;86.82%]
source quote (p.9)
“The second operating point, “high sensitivity” reported a sensitivity of 94.02% (95% CI: [91.39%;95.89%]) and a specificity of 83.50% (95% CI: [79.55%;86.82%]).”
sensitivityas written: “Sensitivity (high specificity mode)”84.14CI [80.41%;87.27%]
source quote (p.9)
“The “high specificity" operating point, reported a sensitivity of 84.14% (95% CI: [80.41%;87.27%]) and a specificity of 94.00% (95% CI: [91.23%;95.94%]).”
specificityas written: “Specificity (high specificity mode)”94CI [91.23%;95.94%]
source quote (p.9)
“The “high specificity" operating point, reported a sensitivity of 84.14% (95% CI: [80.41%;87.27%]) and a specificity of 94.00% (95% CI: [91.23%;95.94%]).”

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/K200905