HALO

K211788

Nico.Lab B.V. · cleared 2021-07-08 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.”

Algorithmartificial intelligence algorithms

source quote (p.3)

“HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.”

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=427 patients

endpoints: calculation of the performance of the HALO algorithm showed a sensitivity and specificity for LVO detection; median notification time for the detected LVO cases

Reported performance (4 observations)

sensitivity0.913CI 95% CI, 86.6%-94.8%

source quote (p.7)

“showed a sensitivity and specificity for LVO detection of respectively 91.3% (95% CI, 86.6%-94.8%)”

specificity0.859CI 95% CI, 80.6%-90.2%

source quote (p.7)

“and 85.9% (95% CI, 80.6%-90.2%).”

aurocas written: “auc”0.97

source quote (p.7)

“The area under the curve (AUC) is 0.97.”

time_to_resultas written: “median notification time”stated without valueCI minimum of 3:47 and maximal 7:12

source quote (p.7)

“For the secondary endpoints the median notification time for the detected LVO cases was 4 minutes 29 seconds, with a minimum of 3:47 and maximal 7:12.”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).