AI-Rad Companion (Cardiovascular)
K222360Siemens Medical Solutions U.S.A. · cleared 2023-04-06 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“AI-Rad Companion (Cardiovascular) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases.”
source quote (p.6)
“AI-Rad Companion (Cardiovascular) SW version VA20 is an enhancement to the previously cleared device AI-Rad Companion (Cardiovascular) K183268 that utilizes machine and deep learning algorithms to provide quantitative and qualitative analysis to computed tomography DICOM images to support qualified clinicians in the evaluation and assessment of cardiovascular diseases.”
source quote (p.6)
“Although the structure of the underlying neural network has not changed in the subject device of this submission, the performance was enhanced over the previously cleared device by adding training data (re-use of existing annotations + 267 additional annotations).”
source quote (p.10)
“Siemens Healthineers adheres to the cybersecurity requirements as defined the FDA Guidance “Content of Premarket Submission for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff” (October 2, 2014) by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.”
Validation studies (3)
Retrospective clinical
n=315 cases
endpoints: Performance of aorta segmentation
standards: 62366-1:2015-02, 14971:2019, 62304:2006/A1:2016, PS 3.1-3.20 (2016)
Retrospective clinical
n=193 cases
endpoints: Accuracy of aortic diameter measurements at nine predefined locations; Accuracy of aortic diameter measurements at maximum ascending and maximum descending aorta
standards: 62366-1:2015-02, 14971:2019, 62304:2006/A1:2016, PS 3.1-3.20 (2016)
Bench
sample size not stated
endpoints: assess the performance claims as well as the claim of substantial equivalence to the predicate device
standards: 62366-1:2015-02, 14971:2019, 62304:2006/A1:2016, PS 3.1-3.20 (2016)
Reported performance (1 observation)
source quote (p.11)
“For the subject device, average DICE (± std. dev) coefficient was 0.924 (± 0.046)”
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).