NinesAI

K193351

Nines, Inc. · cleared 2020-04-21 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“NinesAI is a software device and does not come into contact with patients.”
AlgorithmArtificial Intelligence (AI) technology, machine learning (ML) algorithms
source quote (p.4)
“The image analysis uses Artificial Intelligence (AI) technology to analyze non contrast CT Head scans for the presence of Intracranial Hemorrhage and/or Mass Effect. More specifically, the device utilizes two machine learning (ML) algorithms to detect each finding respectively.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

sample size not stated · 20 site(s)

endpoints: sensitivity; specificity; Positive Predictive Value; Negative Predictive Value; ROC AUC; time savings relative to standard of care; agreement rate between labelers who determined ground truth

Reported performance (6 observations)

sensitivity0.899CI [0.837, 0.940]
source quote (p.7)
“0.899 [0.837, 0.940]”
specificity0.974CI [0.994, 0.992]
source quote (p.7)
“0.974 [0.994, 0.992]”
time_to_resultas written: “Time-to-open-dictation standard of care (Mean)”159.4CI [67.07, 251.7]
source quote (p.7)
“159.4 [67.07, 251.7]”
time_to_resultas written: “Time-to-open-dictation standard of care (Median)”6
source quote (p.7)
“6.0”
time_to_resultas written: “Time-to-open-dictation standard of care (Mean)”28.5CI [14.1, 42.8]
source quote (p.8)
“28.5 [14.1, 42.8]”
time_to_resultas written: “Time-to-open-dictation standard of care (Median)”7.5
source quote (p.8)
“7.5”

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/K193351