StrokeViewer Perfusion
K231570NICo-Lab B.V. · cleared 2023-12-14 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“StrokeViewer Perfusion is an image processing software package intended to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients. It is to be used by medical imaging professionals who analyze dynamic perfusion studies, including but not limited to physicians such as neurologists, and radiologists. The software is packed as a Docker container allowing installation on a standard “off-the-shelf" computer or a virtual platform.”
source quote (p.6)
“StrokeViewer Perfusion is an image processing application that runs on a standard "off-the-shelf" computer or a virtual platform, and can be used to perform image processing and analysis of CT perfusion images of the brain. The software can receive, identify and extract DICOM information embedded in the imaging data. The output includes parametric maps related to tissue blood flow (perfusion) and tissue blood volume. Results of the analysis are exported as DICOM series and DICOM reports and can be sent to a preconfigured destination and can be reviewed on a compatible DICOM viewer. StrokeViewer Perfusion image analysis includes calculation of the following perfusion related parameters: Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT), Residue function time-to-peak (TMax), Arterial Input Function (AIF), Volume calculations of affected tissue based on Tmax and CBF abnormalities.”
source quote (p.8)
“"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices-Final Guidance", October 2, 2014”
Validation studies (1)
Bench
sample size not stated
standards: ISO 14971:2019, IEC 62366-1:2015+AMD1:2020, IEC 62304:2006/A1:2016, NEMA PS 3.1 - 3.20 2022d, ISO 15223-1 Fourth edition 2021-07, ISO 20417 First edition 2021-04 Corrected version 2021-12, IEC 82304-1 Edition 1.0 2016-10, ISO 13485:2016, ISO/IEC 27001:2022, NEN 7510-1:2017+A1:2020, NEN 7510-2:2017
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
- 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
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97993
- …and 20 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).