LungQ 4

K250766

Thirona BV · cleared 2025-10-02 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“The LungQ software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. LungQ is a docker image with a stand-alone command-line software which must be run from a command-line interpreter and does not have a graphical user interface.”

Algorithmsoftware that performs Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, estimated chronic perfusion defect analysis, fissure evaluation and reporting tools

source quote (p.4)

“The Thirona LungQ software provides reproducible CT values for pulmonary tissue and specified endobronchial implants which is essential for providing quantitative support for diagnosis, treatment planning and follow up examination. The LungQ software can be used to support physician in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, estimated chronic perfusion defect analysis, fissure evaluation and reporting tools are provided.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (3)

Standalone

sample size not stated

endpoints: measurement of lung structure parameters, such as (sub)segment volume and density analysis, density scores (LAA-950HU and LAA-910HU) and airway segmentation analysis

Retrospective clinical

sample size not stated

endpoints: Detection performance was evaluated by calculating the sensitivity and precision of the valve analysis component.

Retrospective clinical

sample size not stated

endpoints: Agreement between LungQ 4 and both planar perfusion scintigraphy and SPECT-CT was assessed through intra-class correlation coefficients (ICC) and Bland-Altman analysis.; experienced pulmonologists reviewed whether the use of LungQ 4 CT derived chronic perfusion defect analysis would provide similar quantitative support for treatment planning as SPECT-CT.

Reported performance (2 observations)

sensitivity0.95

source quote (p.10)

“A valve detection sensitivity "ge" 95% and a valve detection precision of ">= 90%" was achieved and therefore the performance of the valve analysis component met the acceptance criteria.”

ppvas written: “Precision”0.9

source quote (p.10)

“A valve detection sensitivity ">= 95%" and a valve detection precision of ">= 90%" was achieved and therefore the performance of the valve analysis component met the acceptance criteria.”

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

recalls in product code, 24mo

192

MAUDE reports in code, 12mo

-22%

vs code's own 3-yr baseline

drift signals on this device

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).