Rapid Aneurysm Triage and Notification

K230074

iSchemaView Inc. · cleared 2023-07-27 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Rapid ANRTN software device is a radiological computer-assisted image processing software device. The Rapid ANRTN device is a CTA processing module which operates within the integrated Rapid Platform to determine the suspicion of head saccular aneurysm(s). The ANRTN software analyzes input CTA images that are provided in DICOM format and provides notification of suspected saccular aneurysm(s) and a non-diagnostic, compressed image for preview. Rapid ANRTN is an AI/ML image processing module which integrates within the Rapid Platform.”
Algorithmartificial intelligence algorithm
source quote (p.3)
“Rapid ANRTN uses an artificial intelligence algorithm to analyze images and highlight studies with suspected saccular aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“Rapid ANRTN has been developed using the cybersecurity framework defined within the FDA Draft Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

Validation studies (1)

Standalone

n=266 cases

endpoints: AUC 0.95 for high performance per the QFM product code definition

standards: EN ISO 14971:2019 (R2021), IEC 62304:2006 (R2015), IEC 62366:2015 (R2020), NEMA PS 3.1 - 3.20

Reported performance (19 observations)

sensitivity0.933
source quote (p.9)
“Additionally, Sensitivity (0.933) and Specificity(0.868) supported the finding.”
specificity0.868
source quote (p.9)
“Additionally, Sensitivity (0.933) and Specificity(0.868) supported the finding.”
aurocas written: “auc”0.95
source quote (p.9)
“The primary endpoint passed with AUC 0.95 for high performance per the QFM product code definition.”
sensitivityas written: “GE Sensitivity”0.973CI 0.862-0.995
source quote (p.10)
“GE Sensitivity 37 0.973 0.862 0.995”
specificityas written: “GE Specificity”0.875CI 0.719-0.950
source quote (p.10)
“GE Specificity 32 0.875 0.719 0.950”
sensitivityas written: “PHILIPS Sensitivity”0.842CI 0.624-0.945
source quote (p.10)
“PHILIPS Sensitivity 19 0.842 0.624 0.945”
specificityas written: “PHILIPS Specificity”0.857CI 0.654-0.950
source quote (p.10)
“PHILIPS Specificity 21 0.857 0.654 0.950”
sensitivityas written: “SIEMENS Sensitivity”0.889CI 0.747-0.956
source quote (p.10)
“SIEMENS Sensitivity 36 0.889 0.747 0.956”
specificityas written: “SIEMENS Specificity”0.818CI 0.656-0.914
source quote (p.10)
“SIEMENS Specificity 33 0.818 0.656 0.914”
sensitivityas written: “TOSHIBA Sensitivity”0.976CI 0.877-0.996
source quote (p.10)
“TOSHIBA Sensitivity 42 0.976 0.877 0.996”
specificityas written: “TOSHIBA Specificity”0.929CI 0.774-0.980
source quote (p.10)
“TOSHIBA Specificity 28 0.929 0.774 0.980”
sensitivityas written: “Female Sensitivity”0.958CI 0.898-0.984
source quote (p.10)
“Female Sensitivity 96 0.958 0.898 0.984”
specificityas written: “Female Specificity”0.868CI 0.752-0.935
source quote (p.10)
“Female Specificity 53 0.868 0.752 0.935”
sensitivityas written: “Male Sensitivity”0.861CI 0.713-0.939
source quote (p.10)
“Male Sensitivity 36 0.861 0.713 0.939”
specificityas written: “Male Specificity”0.902CI 0.790-0.957
source quote (p.10)
“Male Specificity 51 0.902 0.790 0.957”
sensitivityas written: “ANR Size [4, 5) Sensitivity”0.927CI 0.806-0.975
source quote (p.10)
“ANR Size [4, 5) Sensitivity 41 0.927 0.806 0.975”
sensitivityas written: “ANR Size [5, 7) Sensitivity”0.944CI 0.849-0.981
source quote (p.10)
“ANR Size [5, 7) Sensitivity 54 0.944 0.849 0.981”
sensitivityas written: “ANR Size [7, 10) Sensitivity”0.893CI 0.728-0.963
source quote (p.10)
“ANR Size [7, 10) Sensitivity 28 0.893 0.728 0.963”
sensitivityas written: “ANR Size [10, 25) Sensitivity”1CI 0.741-1.000
source quote (p.10)
“ANR Size [10, 25) Sensitivity 11 1.000 0.741 1.000”

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
1
drift signals on this device
  • 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/K230074