Rapid MLS

K243378

iSchemaview Inc. · cleared 2025-05-28 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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 device provides the user with annotated images showing measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of NCCT cases.”
Algorithmmachine learning algorithms
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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
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; difference plot shows no bias (paired t-test p-value = 0.1800)

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

0
recalls in product code, 24mo
3
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/K243378