510(k) · Cleared
ClearedQuantib Prostate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantib B.V. · LLZ System, Image Processing, Radiological
Cleared on Oct 11, 2020 as substantially equivalent to K192200 (Invivo Corporation, 2019) after a 41-day review. Its family tree reaches back 2 generations to 2012. 3 later devices descend from it.
- Decided
- Oct 11, 2020
- Review
- 41 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K121517 (2012). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK121517 Versavue Enterprise SuiteIcad, Inc. · 2012 · Recalled
- 1 generation backK192200 DynaCADInvivo Corporation · 2019
- This deviceK202501 Quantib ProstateQuantib B.V. · 2020
- Descendant · cites it directly · 1 of its ownK221106 Quantib ProstateQuantib B.V. · 2022
- Descendant · cites it directly · 0 of its ownK233196 Medihub ProstateJLK, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK230772 Quantib ProstateQuantib B.V. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K121517 | Versavue Enterprise Suite | Icad, Inc. | 2012 | 1 |
| −1 | K192200 | DynaCAD | Invivo Corporation | 2019 | — |
| 0 (this device) | K202501 | Quantib Prostate | Quantib B.V. | 2020 | — |
| +1 | K221106 | Quantib Prostate | Quantib B.V. | 2022 | — |
| +1 | K233196 | Medihub Prostate | JLK, Inc. | 2024 | — |
| +2 | K230772 | Quantib Prostate | Quantib B.V. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192200 | DynaCADSummary page 4…ication system Product Code: LLZ Regulation number: 892.2050 Device Class: II 3 PREDICATE DEVICE Device: DynaCAD Manufacturer: Invivo Corporation 510(k) Reg. No: K192200 This predicate has not been subject to a design-related recall. Product Code: LLZ Device Class: II 4 DEVICE DESCRIPTION Q… | 2019 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K221106 (Quantib B.V., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K192200.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including images overlaid onto source MRI images. Quantib Prostate functionality includes registered…
Read the full statement (148 words)
Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including images overlaid onto source MRI images.
Quantib Prostate functionality includes registered multiparametric-MRI viewing, with the option to view images combined into a single image to support visualization. The software can be used for semi-automatic segmentation of anatomical structures and provides volume computations, together with tools for manual editing. PI-RADS scoring is possible using a structured workflow.
Quantib Prostate is intended to be used by trained medical professionals and provides information that, in a clinical setting, may assist in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using Quantib Prostate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202501: Quantib Prostate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202501
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026