Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“ClariPulmo is a standalone software application analyzing lung CT images that can be used to support the physician in the quantification of lung CT image when examining pulmonary tissues.”

Algorithmpre-trained deep learning model, U-Net architecture

source quote (p.6)

“Lungs are automatically segmented using a pre-trained deep learning model. The Kernel Normalization algorithm was constructed based on the U-Net architecture. The Denoising algorithm was constructed based on the U-Net architecture.”

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)

Bench

sample size not stated

endpoints: excellent agreement (PCC: 0.980 – 0.983)

standards: ISO 14971 Medical devices – Application of risk management to medical devices., NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005., Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.

Bench

sample size not stated

endpoints: excellent agreement (PCC: 0.99)

standards: ISO 14971 Medical devices – Application of risk management to medical devices., NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005., Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.

Bench

sample size not stated

endpoints: PCC of 0.977~0.992; DICE coefficients of 0.98~0.99 with statistical significance across normal/LAA/HAA patients, CT scanner, reconstructed kernel and low-dose subgroups

standards: ISO 14971 Medical devices – Application of risk management to medical devices., NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005., Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.

Reported performance (1 observation)

diceas written: “DICE coefficients (AI-based lung segmentation)”stated without valueCI 0.98~0.99

source quote (p.8)

“and DICE coefficients of 0.98~0.99 with statistical significance across normal/LAA/HAA patients, CT scanner, reconstructed kernel and low-dose subgroups.”

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

48

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

26

drift signals on this device

adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98137
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97993
…and 20 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).