ContaCT

DEN170073

Viz.Al, Inc. · granted 2018-02-13 · product code QAS · Radiology

FDA De Novo summary for ContaCT (DEN170073)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
0
Performance observations
7
Product code
QAS
FDA De Novo source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“ContaCT is a software only device that can be segmented into three components: (1) Image Forwarding Software, (2) Image Processing and Analysis Software, and (3) Image Viewing Software.”
AlgorithmThe ContaCT algorithm identifies applicable CTA series and verifies that contrast is visible in the soft matter of the brain and that no metallic artifacts such as aneurism clips are present in the soft matter of the brain. Skull stripping and registration steps are performed. The large vessels are identified and segmented, and the amount of extension of the contrast filled segments is compared to a pre-defined threshold. If the threshold exceeds the magnitude of the contrast filled segment, a notification is generated.
source quote (p.4)
“The ContaCT algorithm identifies applicable CTA series and verifies that contrast is visible in the soft matter of the brain and that no metallic artifacts such as aneurism clips are present in the soft matter of the brain. Skull stripping and registration steps are performed. The large vessels are identified and segmented, and the amount of extension of the contrast filled segments is compared to a pre-defined threshold. If the threshold exceeds the magnitude of the contrast filled segment, a notification is generated.”
Adaptive (vs locked)No
source quote (p.3)
“ContaCT performs vessel segmentation and quantifies image characteristics consistent with a Large Vessel Occlusion (LVO) in a large cerebral vessel, and sends a notification based on a fixed threshold to a neurovascular specialist, recommending review of these images.”
PCCPNo
Cybersecurity addressedYes
source quote (p.7)
“Cybersecurity: The cybersecurity documentation is consistent with the recommendations for information that should be included in premarket submissions outlined in the FDA guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (issued October 2, 2014). Information related to cybersecurity reviewed included: Hazard analysis related to cybersecurity risks, traceability documentation linking cybersecurity controls to risks considered, summary plan for validating software updates and patches throughout the lifecycle of the medical device, summary describing controls in place to ensure that the medical device will maintain its integrity, and device instructions for use and product specifications related to recommended cybersecurity controls appropriate for the intended use of the device.”

Validation studies (1)

Retrospective clinical

n=300 images · 2 site(s)

endpoints: Sensitivity; Specificity; CTA-to-Notification Time

standards: NEMA PS 3.1 - 3.20 (2016), Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005), Guidance for Industry and Food and Drug Administration Staff: Computer -Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions (issued July 3, 2012)

Reported performance (7 observations)

sensitivity0.878CI 81.2% - 92.5%
source quote (p.10)
“Sensitivity and specificity were 87.8% (95% CI: 81.2% - 92.5%) and 89.6% (95% CI: 83.7%- 93.9%), respectively.”
specificity0.896CI 83.7%- 93.9%
source quote (p.10)
“Sensitivity and specificity were 87.8% (95% CI: 81.2% - 92.5%) and 89.6% (95% CI: 83.7%- 93.9%), respectively.”
aurocas written: “auc”0.91
source quote (p.10)
“Furthermore, the area under the receiver operating characteristic curve (ROC) was 0.91, demonstrating the clinical utility and ability of the device to effectively triage based on the imaging study results.”
time_to_resultas written: “Standard of Care CTA-to-notification time (average)”58.72CI [46.21, 71.23]
source quote (p.10)
“The average and median CTA-to-notification times were 58.72 minutes and 51.50 minutes, respectively, for the Standard of Care (two-sided 95% confidence interval for the mean: [46.21, 71.23].”
time_to_resultas written: “Standard of Care CTA-to-notification time (median)”51.5
source quote (p.10)
“The average and median CTA-to-notification times were 58.72 minutes and 51.50 minutes, respectively, for the Standard of Care (two-sided 95% confidence interval for the mean: [46.21, 71.23].”
time_to_resultas written: “ContaCT CTA-to-notification time (average)”7.32CI [5.51, 9.13]
source quote (p.10)
“The average and median CTA-to-notification times were 7.32 minutes and 5.60 minutes, respectively, for ContaCT (two-sided 95% confidence interval for the mean: [5.51, 9.13]).”
time_to_resultas written: “ContaCT CTA-to-notification time (median)”5.6
source quote (p.10)
“The average and median CTA-to-notification times were 7.32 minutes and 5.60 minutes, respectively, for ContaCT (two-sided 95% confidence interval for the mean: [5.51, 9.13]).”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision 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 2026-08-26.

Reimbursement — how devices like this got paid

ntap2020-10-01

NTAP max add-on $1,040 (expired) ·

First AI/ML software to receive a CMS New Technology Add-on Payment. CMS cited demonstrated time savings, improved clinical outcomes, and increased access to care. Billed under ICD-10-PCS 4A03X5D. Discontinued after FY2022 (NTAP is a time-limited add-on).

Viz.ai NTAP grant (PR Newswire, 2020)NTAP renewal (Business Wire, 2021)FDA De Novo DEN170073 decision summary

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo 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.

Related FDA clearances

More AI/ML devices under product code QAS

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN170073