Quantib Prostate

K221106

Quantib BV · cleared 2022-05-13 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images.”

AlgorithmAI Node software platform for analysis of prostate MRI scans, including a semi-automatic prostate segmentation algorithm extended to divide into sub-regions (central gland, peripheral zone, and urethra).

source quote (p.4)

“Quantib Prostate is an extension to the Quantib AI Node software platform and enables analysis of prostate MRI scans. Quantib Prostate makes use of Quantib AI Node functionality, and includes the following specific Quantib Prostate modules: An automatic processing module that performs prostate and prostate sub-region segmentation and multi-parametric MRI image registration and computation of a biparametric combination image. A user-interaction module in which the user can edit and approve the computed prostate segmentation and determine PSA density. A user-interaction module in which the user can view multi-parametric MRI images, segment and analyze potential lesions and set and view PI-RADS properties. This module also shows the prostatic sub-region segmentation and biparametric combination image overlay. An automatic processing module that collects all results, and creates the report and DICOM output so that they can be exported back to the user. The semi-automatic prostate segmentation is extended with an algorithm to divide the prostate segmentation into sub-regions (central gland, peripheral zone, and urethra), without impacting the original prostate segmentation.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.6)

“Cybersecurity and vulnerability analysis”

Validation studies (2)

Bench

sample size not stated

endpoints: Dice overlap; Mean Surface Distance; agreement between automatic method and manual segmentation; inter-observer measurements

standards: ISO 14971, IEC 62304, IEC 62366-1

Reader study (MRMC)

sample size not stated

endpoints: 5-point Likert scale score for sub-region segmentations and ROI initial localizations; high quality judgment of sub-regions and ROI localizations

standards: ISO 14971, IEC 62304, IEC 62366-1

Reported performance (1 observation)

diceas written: “Dice overlap”stated without value

source quote (p.7)

“calculating the Dice overlap and Mean Surface Distance.”

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
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
…and 21 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).