iSchemaView RAPID
K182130iSchemaView, Inc. · cleared 2018-12-27 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“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 is a software-only device consisting of one or more RAPID Servers (dedicated or virtual and an iSchemaView Server).”
source quote (p.5)
“RAPID is a toolbox of modules which support various analysis methods used in clinical practice today: RAPID CTA: used to visualize large cerebral vessels and analyze hemispheric difference via contralateral comparison. RAPID MR DWI Module: used to visualize local water diffusion properties of tissue from the analysis of diffusion-weighted MRI data. RAPID Dynamic Analysis Module: 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. CT-Perfusion, MR-Perfusion and MR-Diffusion datasets, with the possibility to compute semi-quantitative (relative blood flow, volume, mean transit time, arterio-tissue delay time Tmax) and quantitative (apparent diffusion coefficient) parameters and compute volumes of tissue with parameters within certain ranges; CT-Angiography datasets, where, after skull stripping, the system provides transverse, coronal and sagittal views of the intra-cranial vasculature, as well as hemispheric comparison of the blood vessel density in these datasets.”
source quote (p.6)
“The iSchemaView Server 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
endpoints: accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software; met all design requirements and specifications
standards: EN ISO 14971:2012, IEC 62304:2015, IEC 62366:2015, NEMA PS 3.1 - 3.20, 21 CFR, Part 820.30
Retrospective clinical
sample size not stated
endpoints: selection of acute stroke patients for endovascular thrombectomy
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) 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
- adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98137
- …and 21 more.
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).