Canvas Dx

K243558

Cognoa, Inc. · cleared 2025-04-11 · product code QPF · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Canvas Dx consists of Software as a Medical Device (SaMD) together with several medical device data system (MDDS) components.”
Algorithmmachine learning (ML) algorithm
source quote (p.6)
“A machine learning (ML) algorithm (‘Algorithm') modeled after standard medical evaluation methodologies and drives the device outputs.”
Adaptive (vs locked)Yes
source quote (p.9)
“Retraining the model based on new data enables the Device to adapt, improving generalizability and maintaining performance across evolving clinical populations.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedYes
source quote (p.6)
“Several supporting software and backend services and infrastructure, including privacy and security encryption and infrastructure in compliance with HIPAA and other best practices.”

Validation studies (2)

Bench

sample size not stated

standards: IEC 62304:2006

Prospective clinical

sample size not stated · 14 site(s)

Reported performance (4 observations)

sensitivity0.9844CI 91.6%-99.96%
source quote (p.8)
“Sensitivity: 98.44% (CI: 91.6%-99.96%)”
specificity0.7887CI 67.56%-87.67%
source quote (p.8)
“Specificity: 78.87% (CI: 67.56%-87.67%)”
ppvas written: “PPV”0.8077CI 70.27-88.82%
source quote (p.8)
“PPV: 80.77% (CI: 70.27-88.82%)”
npvas written: “NPV”0.9825CI 90.61-99.96%
source quote (p.8)
“NPV: 98.25% (CI: 90.61-99.96%)”

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 Neurology 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/K243558