QUIBIM Precision Prostate (qp-Prostate)

K203582

QUIBIM S.L. · cleared 2021-02-04 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“qp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of qp-Prostate. qp-Prostate does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data.”

AlgorithmModular platform based on a plug-in software architecture, including Apparent Diffusion Coefficient (ADC) post-processing, Perfusion – Pharmacokinetics post-processing (PKM), Spatial Smoothing algorithm, Registration algorithm, Automated Prostate Segmentation algorithm, Motion Correction algorithm and automated AIF selection algorithm.

source quote (p.5)

“qp-Prostate consists of a modular platform based on a plug-in software architecture. Apparent Diffusion Coefficient (ADC) post-processing and Perfusion – Pharmacokinetics post-processing (PKM) are embedded into the platform as plug-ins to allow prostate imaging quantitative analysis.A dataset of prostate clinical cases was used for the validation of the algorithms integrated in qp-Prostate v1.0.0 such as Spatial Smoothing algorithm, Registration algorithm, Automated Prostate Segmentation algorithm, Motion Correction algorithm and auto mated AIF selection algorithm.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.7)

“Both uniquely identify users and maintain audit trails of user actions.Unique user log-in and passwordUser audit trails”

Validation studies (8)

Bench

sample size not stated

Bench

sample size not stated

Retrospective clinical

n=155 patients

Retrospective clinical

sample size not stated

Retrospective clinical

n=51 patients

Retrospective clinical

n=242 patients

Retrospective clinical

n=243 patients

Retrospective clinical

n=157 patients

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

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).