Rapid ASPECTS

K200760

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

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.13)

“Both devices are SaMD's with similar algorithm development approaches using variants of artificial intelligence implementations.”

Algorithmartificial intelligence algorithm, machine learning implementation, 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 (2)

Bench

sample size not stated

standards: ISO 14971:2019, IEC 62304:2015, IEC 62366:2015, NEMA PS 3.1 - 3.20

Reader study (MRMC)

n=50 cases

endpoints: statistically significant improvement in the accuracy of the 8 readers' scores; increased their agreement with an expert consensus read; agreed, on average, with almost ½ a region 0.425 (95% CI 0.11 – 0.74) more per scan; improve their level of agreement from 73.6% to 79.8%

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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). 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).