Rapid ASPECTS

K200760

iSchemaView Inc. · cleared 2020-06-26 · product code POK · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.”
Algorithmartificial intelligence algorithm; random forest machine learning technique
source quote (p.3)
“The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. Rapid ASPECTS is a machine learning implementation using the processing pipeline below. Rapid ASPECTS provides an automatic ASPECT score based on the case input file for the physician. The score includes which ASPECT regions are identified based on regional imaging features derived from non-contrast computed tomography (NCCT) brain image data based on the random forest machine learning technique.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Reader study (MRMC)

n=50 cases

endpoints: agreement with an expert consensus read; level of agreement

Bench

sample size not stated

Retrospective clinical

sample size not stated

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
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K232156 (decision 2024-01-19) from iSchemaView, Inc. for a matching device line ("Rapid ASPECTS (v3)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K232156

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233512 (decision 2024-01-16) from iSchemaView, Inc. for a matching device line ("Rapid (6.0)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233512

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/K200760