Rapid (6.0)

K233512

iSchemaView, Inc. · cleared 2024-01-16 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Rapid is a Software as a Medical Device (SaMD) consisting of one or more Rapid Servers (dedicated or virtual) in on-premises or hybrid (on-premises/cloud) configurations.”
AlgorithmImage processing software package that provides for the visualization and study of changes in tissue using digital images captured by diagnostic imaging systems including CT (Computed Tomography) and MRI (Magnetic Image Resonance), as an aid to physician diagnosis. It provides viewing, quantification, analysis and reporting capabilities for functional and dynamic imaging datasets, including CT analysis for hypodense and hyperdense tissue, DWI Module for water diffusion properties, and Dynamic Analysis Module for changes in contrast over time, including calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
source quote (p.3)
“Rapid is a software package that provides for the visualization and study of changes in tissue using digital images captured by diagnostic imaging systems including CT (Computed Tomography) and MRI (Magnetic Image Resonance), as an aid to physician diagnosis. Rapid can be installed on a customer's Server or it can be accessed online as a virtual system. It provides viewing, quantification, analysis and reporting capabilities. Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CTP), CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT). The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.7)
“The iSchemaView Server is a dedicated server that provides a central repository for Rapid data. All iSchemaView Server data is stored on encrypted hard drives within the hospital infrastructure. It also provides a user interface for accessing Rapid data. It connects to a firewalled Data Center Network and has its own firewall for additional cyber/data security. It supports secure VPN (Virtual Private Network) networking or encapsulated Secure Shell (SSH), and seamlessly integrates into an existing radiological data network.”

Validation studies (2)

Bench

sample size not stated

standards: EN ISO 14971:2019, IEC 62304:2016, IEC 62366:2015

Retrospective clinical

sample size not stated

standards: EN ISO 14971:2019, IEC 62304:2016, IEC 62366:2015

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
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
6
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251987 (decision 2025-09-23) from iSchemaView, Inc. for a matching device line ("Rapid Aortic Measurements") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251987

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251533 (decision 2025-09-04) from iSchemaView Inc. for a matching device line ("Rapid Obstructive Hydrocephalus, Rapid OH") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251533

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251151 (decision 2025-07-16) from iSchemaView for a matching device line ("Rapid CTA 360") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251151

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243378 (decision 2025-05-28) from iSchemaview Inc. for a matching device line ("Rapid MLS") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243378

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243350 (decision 2025-01-22) from iSchemaView, Inc. for a matching device line ("Rapid Neuro3D") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243350

  • 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

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/K233512