510(k) · Cleared
ClearedQbrain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medis Medical Imaging Systems BV · LLZ System, Image Processing, Radiological
Cleared on Apr 21, 2005 as substantially equivalent to K011196 (Insightful Corporation, 2001) after a 34-day review. Its family tree reaches back 1 generation to 2001. 8 later devices descend from it.
- Decided
- Apr 21, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011196 (2001). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK011196 Iquantify, Version 1.0Insightful Corporation · 2001
- This deviceK050703 QbrainMedis Medical Imaging Systems BV · 2005
- Descendant · cites it directly · 5 of its ownK153351 Quantib Brain 1Quantib B.V. · 2016
- Descendant · 2 generations on · 4 of its ownK163013 Quantib Brain 1.2Quantib B.V. · 2017
- Descendant · 3 generations on · 3 of its ownK173939 Quantib BrainQuantib B.V. · 2018
- Descendant · 4 generations on · 2 of its ownK182564 Quantib NDQuantib B.V. · 2018
- Descendant · 5 generations on · 1 of its ownK213737 Quantib NDQuantib B.V. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153351Quantib Brain 1Quantib B.V. · 2016 · cites it directly5descendants
- K163013Quantib Brain 1.2Quantib B.V. · 2017 · 2 generations on4descendants
- K173939Quantib BrainQuantib B.V. · 2018 · 3 generations on3descendants
- K182564Quantib NDQuantib B.V. · 2018 · 4 generations on2descendants
- K213737Quantib NDQuantib B.V. · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011196 | Iquantify, Version 1.0 | Insightful Corporation | 2001 | — |
| 0 (this device) | K050703 | Qbrain | Medis Medical Imaging Systems BV | 2005 | — |
| +1 | K153351 | Quantib Brain 1 | Quantib B.V. | 2016 | — |
| +2 | K163013 | Quantib Brain 1.2 | Quantib B.V. | 2017 | — |
| +3 | K173939 | Quantib Brain | Quantib B.V. | 2018 | — |
| +4 | K182564 | Quantib ND | Quantib B.V. | 2018 | — |
| +5 | K213737 | Quantib ND | Quantib B.V. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K011196 | Iquantify, Version 1.0Summary page 1…ass. Name : Class II; PACS software Regulation Number : 21 CFR 892.2050 (90 LLZ) * Predicate Device(s) : IQuantify workstation software, K011196 · Device Description and indications for Use vendors. Mask data, QBrain is able to read DICOM MR images f… | 2001 |
What descends from it? (8)
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?
- Its one ancestor has no recall.
- Of its descendants, K153351 (Quantib B.V., 2016) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The QBrain software has been developed for the objective and
reproducible analysis of MR images of the brain. It performs quantitative analysis of MR
brain images based on automatic segmentation. More specifically, it quantifies the
volumes of intracranial cavities, areas that contain cerebrospinal fluid (CSF), and white
matter hyperintensities (lesions).
These parameters should only be used by trained medical professionals. They may be
used to support diagnosis in clinical practice and to reach conclusions in clinical trials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050703: Qbrain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050703
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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