TruPlan Computed Tomography (CT) Imaging Software
K222593Circle Cardiovascular Imaging, Inc. · cleared 2023-01-18 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The TruPlan Computed Tomography (CT) Imaging Software application (“TruPlan”) is a software as a medical device that helps qualified users with image-based pre-procedural planning and post-procedural follow-up of the Left Atrial Appendage Closure (LAAC) procedure using CT data.”
source quote (p.5)
“TruPlan implements machine learning techniques to aid device use as follows: 1. Left Heart Segmentation. TruPlan generates a 3D rendering of the left side of the heart (including left ventricle, left atrium, and LAA) using machine learning methodology. [...] 2. Landing Zone Detection. TruPlan uses machine learning techniques to initialize landing zone detection.”
source quote (p.6)
“None of the cases used for model validation were used for training the machine learning models. [...] All data used for validation were not used during the development of the training algorithms.”
source quote (p.10)
“Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance documents “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices”.”
Validation studies (2)
Retrospective clinical
n=533 cases
endpoints: segmentation accuracy defined by probability of bone removal and probability of LAA visualization
standards: ISO 13485:2016, IEC 62304:2015, ISO 14971:2019, NEMA 3.1-3.20 (2016) DICOM standards
Retrospective clinical
n=100 patients
endpoints: detection accuracy defined by plane and contour center distance
standards: ISO 13485:2016, IEC 62304:2015, ISO 14971:2019, NEMA 3.1-3.20 (2016) DICOM standards
Reported performance (2 observations)
source quote (p.11)
“Bone was removed in 532/533 cases (99.81%)”
source quote (p.11)
“the LAA was correctly visualized by the rendering algorithm in 519/533 cases (97.37%).”
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
- 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).