AI-Rad Companion (Pulmonary)
K233753Siemens Healthcare GmbH · cleared 2024-03-21 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The subject device AI-Rad Companion (Pulmonary) is an image processing software that utilizes machine learning and deep learning algorithms to provide quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support qualified clinicians in the evaluation and assessment of disease of the thorax.”
source quote (p.6)
“The subject device AI-Rad Companion (Pulmonary) is an image processing software that utilizes machine learning and deep learning algorithms to provide quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support qualified clinicians in the evaluation and assessment of disease of the thorax.”
source quote (p.9)
“Siemens Healthineers adheres to the cybersecurity requirements as defined the FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (September 27, 2023) 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 (2)
Bench
sample size not stated
standards: 62366-1:2020-06, 14971 Third Edition 2019-12, 62304 Edition 1.1 2015-06 Consolidated, PS 3.1-3.20 2022d, 15223-1 Fourth Edition 2021-07
Retrospective clinical
n=527 patients
Reported performance (1 observation)
source quote (p.11)
“For the existing solid and calcified nodule types and sizes, the average DICE coefficient was greater than that of the predicate. For sub-solid nodules, the average DICE coefficient of the subject device was superior to the average DICE coefficient of the predicate device for solid nodules.”
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).