Al-Rad Companion (Pulmonary)

K213096

Siemens Medical Solutions USA, Inc. · cleared 2021-12-06 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Al-Rad Companion is a software only medical system that investigates data from imaging systems. Al-Rad Companion receives these data and checks which post-processing algorithms may be applicable. Data that does not meet the Al-Rad Companion requirements are ignored while data that meets the requirements are sent for further processing. Applicable data are processed, and the results are provided to the user via their clinical workplace. The user has the option to accept, review or withdraw single results of Al-Rad Companion. The scope of this submission is the extension Al-Rad Companion (Pulmonary). It is an image post-processing software that uses CT DICOM data to support clinicians in the evaluation and assessment of lung diseases.”
AlgorithmArtificial Intelligence (AI)-algorithms, machine-learning and deep-learning algorithms
source quote (p.5)
“Al-Rad Companion uses Artificial Intelligence (AI)-algorithms. It 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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedNo

Validation studies (3)

Bench

sample size not stated

standards: Digital Imaging and Communications in Medicine (DICOM) Set; PS 3.1 – 3.20, Medical Device Software -Software Life Cycle Processes; 62304:2006 (1st Edition), Medical devices - Application of risk management to medical devices; 14971 Third Edition 2019-12, Medical devices - Part 1: Application of usability engineering to medical devices IEC 62366-1:2015

Retrospective clinical

n=250 cases

endpoints: Average DICE coefficients

Retrospective clinical

n=150 cases

endpoints: Interreader-variability of the percentage of opaque (PO); 95%-Limits of Agreement (LOA)

Reported performance (1 observation)

diceas written: “Average DICE coefficients”stated without valueCI 0.94 to 0.96
source quote (p.10)
“Average DICE coefficients ranged from 0.94 to 0.96.”

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

75
recalls in product code, 24mo
192
MAUDE reports in code, 12mo
-22%
vs code's own 3-yr baseline
9
drift signals on this device
  • 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 matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:98206

  • 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 (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.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K213096