Rapid Neuro3D

K243350

iSchemaView, Inc. · cleared 2025-01-22 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Rapid Neuro 3D (RN3D) is a Software as a Medical Device (SaMD) image processing module and is part of the Rapid Platform.”
Algorithmpre-trained artificial intelligence / machine-learning models
source quote (p.7)
“The RN3D image processing module is based on pre-trained artificial intelligence / machine-learning models and facilitates a 3D visualization of the neurovasculature supplying arterial blood to the brain.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“Rapid has been designed to meet the cybersecurity requirements using design Vulnerability Assessments, SBOM's, and PEN Testing.”

Validation studies (2)

Retrospective clinical

n=115 patients

endpoints: clinical accuracy; labeling

standards: ISO 14971:2019, IEC 62304:2015, IEC 62366-1:2015 +A1:2020, NEMA PS 3.1 - 3.20, ISO 15223-1:2021

Retrospective clinical

n=48 patients

endpoints: segmentation accuracy; reproducibility; centerline accuracy

Reported performance (3 observations)

accuracyas written: “accuracy for the vessels visualized”100
source quote (p.11)
“The secondary endpoint, labeling, passed with 100% of the anatomical labels applied found to be accurate for the vessels visualized.”
diceas written: “average Dice Coefficient (extracranial)”0.89
source quote (p.12)
“For the extracranial region, the primary endpoint, segmentation accuracy, was met with an average Dice Coefficient of 0.89”
diceas written: “average Dice Coefficient (intracranial)”0.97
source quote (p.12)
“For the intracranial region, the primary endpoint, substantial equivalence, was met with an average Dice Coefficient of 0.97”

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/K243350