Rapid (6.0)
K233512iSchemaView, Inc. · cleared 2024-01-16 · product code QIH · Radiology
Premarket evidence — what FDA accepted
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.”
source quote (p.3)
“Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs ona standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices. 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 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.”
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. The iSchemaView Server connects to one or more Rapid Servers via WAN. Available types of connection include VPN (Virtual Private Network - RFC2401 and RFC4301 Standards) Tunnel and SSH (Secure Shell).”
Validation studies (2)
Bench
sample size not stated
standards: EN ISO 14971:2019, IEC 62304:2016, IEC 62366:2015, NEMA PS 3.1 - 3.20
Retrospective clinical
sample size not stated
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
- 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). 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).