Rapid ASPECTS (v3)

K232156

iSchemaView, Inc. · cleared 2024-01-19 · product code POK · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The Rapid platform is Software as a Medical Device (SaMD)”

AlgorithmAI/Random Forest

source quote (p.13)

“AI/Random Forest”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.8)

“Rapid has been designed to meet cybersecurity requirements using design Vulnerability Assessments, SBOM's, and PEN Testing.”

Validation studies (3)

Reader study (MRMC)

n=88 cases

endpoints: percent agreement

Reader study (MRMC)

n=102 scans

endpoints: reader improvement in percent agreement

Retrospective clinical

n=115 cases

endpoints: minimal effect of confounders/mimics on ASPECTS performance

Reported performance (1 observation)

agreement_kappaas written: “percent agreement (standalone)”82.8

source quote (p.9)

“The percent agreement of Rapid ASPECTS to the reference at the ASPECTS region level and at the scan level is 82.8%.”

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

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).