LungQ v3.0.0
K232412Thirona BV · cleared 2024-01-08 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“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 stand-alone command-line software which must be run from a command-line interpreter and does not have a graphical user interface.”
source quote (p.7)
“AAMI TIR57 Principles for medical device security—Risk management”
Validation studies (1)
Retrospective clinical
sample size not stated
endpoints: Lung and lobar volume: Difference ≤ 10%; LAA-950HU: Agreements limits -1% to 1%; LAA-910HU: Agreement limits -10% and 10%; 15th Percentile: Agreement limits -10 HU to 10 HU; Fissure completeness classification: Az value ≥ 0.95; The tolerable variability for absolute and relative values are 150mL and 5%, respectively.
standards: AAMI TIR57, ANSI AAMI IEC TIR 80002-1, ANSI NEMA HN 1, IEC 62304, IEC 62366-1, IEC 82304-1, ISO 14971, ISO 15223-1, ISO 20417, ISO/IEC 21778, ISO/IEC 27001, NEMA PS 3.1 - 3.20
Reported performance (1 observation)
source quote (p.10)
“The area under the AUC curve (Az value) for the comparison of fissure completeness measurements between LungQ v3.0.0 (subject device) and the primary predicate was found to be 0.97, above the minimal threshold value.”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250766 (decision 2025-10-02) from Thirona BV for a matching device line ("LungQ 4") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250766
- 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
- …and 4 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).