ClearRead CT CAC
K242188Riverain Technologies, Inc. · cleared 2024-12-03 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“ClearRead CT CAC is image processing software designed to aid physicians in assessing coronary artery calcification on non-gated, non-contrast, standard, or low-dose chest CT scans of adult patients 30 years of age or older.”
source quote (p.11)
“This software, as a medical device product, was developed using machine learning to measure the amount of arterial calcification in non-contrast chest CT cases.”
source quote (p.9)
“Guidance for Industry and Food and Drug Administration Staff - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Issues September 27, 2023”
Validation studies (2)
Retrospective clinical
n=400 cases
endpoints: To assess the measurement of the Agatston score, we used weighted kappa scores (weighted, owing to the ordinal nature of the categories) and Bland-Altman analysis.
standards: IEC 62304:2006/AMD1:2016, Medical devices – Software life cycle processes, IEC62366-1:2015, Medical device – Part1: Application of usability engineering to medical devices, ISO14971:2019, Medical devices – Application of Risk Assessment to Medical Devices, NEMA PS 3.1-3-20, Digital Imaging and Communications in Medicine (DICOM) Set 2016, Guidance for Industry and Food and Drug Administration Staff - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Issues September 27, 2023
Retrospective clinical
n=491 cases · 5 site(s)
endpoints: Primary endpoint: the accuracy of ClearRead CT CAC in calculating the Agatston score category (0, 1-99, 100-399, ≥400) as defined by the quadratic weighted Kappa coefficient when compared with ground truth radiologist Agatston score category.; Secondary endpoint: the accuracy of ClearRead CT CAC in calculating the overall continuous Agatston score as assessed by Bland-Altman analysis.; Secondary endpoint: the accuracy of ClearRead CT CAC in segmenting the overall coronary artery calcification as assessed by Dice score comparison.
standards: IEC 62304:2006/AMD1:2016, Medical devices – Software life cycle processes, IEC62366-1:2015, Medical device – Part1: Application of usability engineering to medical devices, ISO14971:2019, Medical devices – Application of Risk Assessment to Medical Devices, NEMA PS 3.1-3-20, Digital Imaging and Communications in Medicine (DICOM) Set 2016, Guidance for Industry and Food and Drug Administration Staff - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Issues September 27, 2023
Reported performance (3 observations)
source quote (p.10)
“A weighted kappa score of 0.958 was achieved, demonstrating good agreement between the automatic method and manual processing.”
source quote (p.11)
“Primary endpoint: kappa of 0.959 (95% CI: 0.943-0.975).”
source quote (p.12)
“Secondary endpoint: Dice score comparison (see Table 2) between the annotator ground truth and automatic outputs, giving average scores of 0.910 (0.893,0.927) and 0.892 (0.871,0.911), respectively.”
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
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98738
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98588
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98206
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97699
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Philips North America Llc, initiated 2025-05-29): "Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97010
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (, initiated 2025-05-23): "Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96967
- …and 3 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).