Quantib Prostate

K221106

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

FDA 510(k) summary for Quantib Prostate (K221106)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
1
Performance observations
0
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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 with an algorithm for semi-automatic prostate segmentation and sub-region segmentation.
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. 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

Reader study (MRMC)

sample size not stated

endpoints: 5-point Likert scale for quality

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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
32
drift signals on this device
  • predicate_cohort_contagion

    K221106 shares predicate K202501 with K233196 (Medihub Prostate), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K202501 sibling:K233196

  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-07-22): "Software issue may cause measurements to be displayed inaccurately." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22): "Software issue may cause the ruler measurement to be inaccurate." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99529

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-06-30): "Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99391

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Boston Scientific Corporation, initiated 2026-06-19): "Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99236

  • …and 26 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-09-02.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Related FDA clearances

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K221106