Hyper Insight - ICH
K240353SK Inc. · cleared 2024-07-01 · product code QAS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“Hyper Insight - ICH is software as a medical device (SaMD) that detects intracranial hemorrhage (ICH) condition by analyzing non-contrast CT images.”
Algorithmdeep learning-based AI algorithms
source quote (p.3)
“Hyper Insight - ICH uses deep learning-based AI algorithms to analyze images to find suspected intracranial hemorrhage and notifies and shares the findings to medical specialists.”
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=394 images · 13 site(s)
endpoints: sensitivity; specificity
Reported performance (4 observations)
sensitivity95.45CI [91.55, 97.90]
source quote (p.7)
“Sensitivity and specificity were 95.45% (95% CI) and 98.47% (95% CI), respectively.”
specificity98.47CI [95.59, 99.68]
source quote (p.7)
“Sensitivity and specificity were 95.45% (95% CI) and 98.47% (95% CI), respectively.”
aurocas written: “auc”0.9864CI [0.9738, 0.9989]
source quote (p.7)
“In addition, the area under the receiver operating characteristic curve (AUC) was 0.9864 demonstrating the clinical utility and potential benefits of the Hyper Insight - ICH based on the imaging study results.”
time_to_resultas written: “Average time to alerting a specialist”16.39CI ±5.46 seconds
source quote (p.8)
“In the study, the average time to analyzing the brain CT image and notify the result of the intracranial hemorrhage identification to the mobile (DICOM VIEWER) was analyzed was 16.39 ± 5.46 seconds (0.27 ± 0.091 minutes), which is lower than the average time to notification seen in the predicate device of 0.49 ±0.15 minutes.”
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). 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).