Broncholab
K191550Fluidda Inc. · cleared 2020-03-04 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Broncholab is a SaMD (Software as Medical Device) which provides quantitative CT values that are intended to support the physician in the diagnosis and documentation of pulmonary tissues images (abnormalities) from CT scans.”
source quote (p.5)
“Inspiratory CT scan images uploaded by the users are converted into quantitative CT values using a combination of software tools. Quality checks (both manual and automated) are implemented to assure the quality of the final data. The outputs are provided as absolute values and as a percentage of the total airway volume/ lung volume/ lobar volume depending on the parameter. The device can be used on a computer with a web browser installed and consists of two accessories: An online portal to upload the CT scans An accessory that enables the creation of the Report”
Validation studies (1)
Bench
sample size not stated
endpoints: lobe volume; emphysema; blood vessel density; 15th percentile lung density (PD15); fissure integrity; airway volume
Reported performance (1 observation)
source quote (p.10)
“The ICC estimate (95% CI) for comparison of the fissure integrity measurements between Broncholab and the primary predicate was found to be 0.75 (0.54, 0.87).”
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).