Quantib Prostate

K202501

Quantib BV · cleared 2020-10-11 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Quantib Prostate is an extension to the Quantib Al Node software platform and enables analysis of prostate MRI scans. Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images.”

Algorithmautomatic processing module that performs prostate segmentation and multi-parametric MRI image registration; semi-automatic algorithm

source quote (p.4)

“An automatic processing module that performs prostate segmentation and multi-parametric MRI image registration. Prostate segmentation algorithm was tested in a clinical use context, i.e. as a semi-automatic algorithm after correction by trained clinicians.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.9)

“Quantib Prostate was designed in compliance with the following US recognized consensus standards: ANSI AAMI ISO 14971:2007/(R)2010 – Medical devices - Application of risk management to medical devices”

Validation studies (2)

Bench

sample size not stated

endpoints: functionality of the system; stand-alone performance of the prostate segmentation algorithm

standards: ANSI AAMI ISO 14971:2007/(R)2010, ANSI AAMI IEC 62304:2006/A1:2016, ANSI AAMI IEC 62366-1:2015

Reader study (MRMC)

sample size not stated

endpoints: comparing the performance of a clinician using Quantib Prostate to segment a prostate with a clinician not using Quantib Prostate; safety and effectiveness of the semi-automatic segmentation algorithm; performs better or equal in prostate segmentation than without use of Quantib Prostate

standards: ANSI AAMI ISO 14971:2007/(R)2010, ANSI AAMI IEC 62304:2006/A1:2016, ANSI AAMI IEC 62366-1:2015

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

re_clearance
The FDA AI/ML device list shows a newer 510(k) K230772 (decision 2023-04-17) from Quantib BV for a matching device line ("Quantib Prostate") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K230772
re_clearance
The FDA AI/ML device list shows a newer 510(k) K221106 (decision 2022-05-13) from Quantib BV for a matching device line ("Quantib Prostate") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K221106
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
…and 22 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).