510(k) · Cleared
ClearedMedihub Prostate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
JLK, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Jun 21, 2024 as substantially equivalent to K202501 (Quantib B.V., 2020) after a 267-day review. Its family tree reaches back 3 generations to 2012.
- Decided
- Jun 21, 2024
- Review
- 267 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K121517 (2012). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K202501 | Quantib ProstateSummary page 4…ulatory Class: II Product Code: QIH Classification regulation: 21 CFR 892.2050 III. PREDICATE DEVICE Device: Quantib Prostate Manufacturer: Quantib B.V. 510(k) No: K202501 Product Code: LLZ Regulatory Class: II IV. DEVICE DESCRIPTION MEDIHUB PROSTATE is an image processing software package for… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K202501.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
MEDIHUB PROSTATE is an image processing software package that performs outlining, processing, viewing, and editing of prostate MR images. The software can support study review and analysis of prostate MR data with computed modules. The analysis result can be presented in various formats, including images overlaid onto source MR images and a structured report. MEDIHUB PROSTATE semi-automatically outlines the prostate based on MR images by contour, and it…
Read the full statement (204 words)
MEDIHUB PROSTATE is an image processing software package that performs outlining, processing, viewing, and editing of prostate MR images. The software can support study review and analysis of prostate MR data with computed modules. The analysis result can be presented in various formats, including images overlaid onto source MR images and a structured report.
MEDIHUB PROSTATE semi-automatically outlines the prostate based on MR images by contour, and it requires the user to edit with image manipulating tools and confirm the final result. The package provides additional functionalities including registered multiparametric-MRI viewing and combining MR sequences into a single image to support visualization. Edited PI-RADS report and semi annotated prostate region can be viewed in each single image in the final report.
MEDIHUB PROSTATE is intended to be used by trained radiologists and urologists. Patient management decisions should not be made solely based on the analysis performed by MEDIHUB PROSTATE.
Limitations:
* MEDIHUB PROSTATE has been validated for use with Siemens 3T Vida and Skyra MRI machines.
* MEDIHUB PROSTATE is also designed for use with the Siemens 3T T2 MRI series, supporting slice thicknesses ranging from 3.5 mm to 5 mm.
* MEDIHUB PROSTATE has been tested on patients aged 55 years and above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233196: Medihub Prostate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233196
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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