Rapid ICH

K193087

iSchemaView Incorporated · cleared 2020-03-31 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“RAPID is a software-only device consisting of one or more RAPID Servers (dedicated or virtual and an iSchemaView Server).”
Algorithmdeep learning algorithm trained on medical images
source quote (p.8)
“Specifically, the subject and predicate software utilize a deep learning algorithm trained on medical images.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.5)
“The iSchemaView Server connects to a firewalled Data Center Network and has its own firewall for additional cyber/data security.”

Validation studies (1)

Retrospective clinical

n=336 cases · 6 site(s)

endpoints: evaluate the software's performance in identifying noncontrast CT head images containing intracranial hemorrhage (ICH) findings; RAPID ICH's time to notification of suspicion non-suspicion

standards: EN ISO 14971:2012, IEC 62304:2015, NEMA PS 3.1 - 3.20

Reported performance (3 observations)

sensitivity0.899CI 0.847 – 0.935
source quote (p.10)
“Specifically, sensitivity was observed to be Se: 0.899 (95% CI: 0.847 – 0.935) and Sp: 0.943 (95% CI: 0.895 – 0.970).”
specificity0.943CI 0.895 – 0.970
source quote (p.10)
“Specifically, sensitivity was observed to be Se: 0.899 (95% CI: 0.847 – 0.935) and Sp: 0.943 (95% CI: 0.895 – 0.970).”
time_to_resultas written: “time to notification of suspicion non-suspicion”2.28CI 2.24 - 2.33
source quote (p.10)
“In addition, a secondary endpoint measure was RAPID ICH's time to notification of suspicion non-suspicion as 2.28 min (95% CI: 2.24 - 2.33) was achieved.”

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
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233582 (decision 2024-04-22) from iSchema View Inc. for a matching device line ("Rapid") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233582

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K223396 (decision 2023-02-01) from iSchema View Inc. for a matching device line ("Rapid RV/LV") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K223396

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K213165 (decision 2022-02-08) from iSchema View Inc. for a matching device line ("Rapid") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K213165

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/K193087