Rapid MLS
K243378iSchemaview Inc. · cleared 2025-05-28 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The Rapid MLS software device is designed to measure the midline shift of the brain from a NCCT acquisition and report the measurements. Rapid MLS analyzes adult cases using machine learning algorithms to identify locations and measurements of the expected brain midline and any shift which may have occurred. The Rapid MLS software device is a radiological computer-assisted image processing software device using AI/ML.”
source quote (p.4)
“Rapid MLS analyzes adult cases using machine learning algorithms to identify locations and measurements of the expected brain midline and any shift which may have occurred. Rapid MLS software device is a radiological computer-assisted image processing software device using AI/ML.”
source quote (p.7)
“UL 2900-1 (2017) Standard for Safety for Cybersecurity Network-Connected Products”
Validation studies (1)
Retrospective clinical
n=153 cases · 13 site(s)
endpoints: mean absolute error (MAE); Passing-Bablok fit intercept; Passing-Bablok fit slope; paired t-test p-value
standards: EN ISO 14971:2019 (R2021), IEC 62304:2006 (R2015), IEC 62366:2015 (R2020), NEMA PS 3.1 - 3.20, UL 2900-1 (2017)
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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
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).