510(k) · Cleared
Recalled · Class II · 2022Nordicbrainex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nordicneurolab · LLZ System, Image Processing, Radiological
Cleared on Apr 4, 2014 as substantially equivalent to K090546 (Nordicimaginglab AS, 2009) after a 102-day review. Its family tree reaches back 8 generations to 1990. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 4, 2014
- Review
- 102 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 9 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 2 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 1 generation backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- This deviceK133910 NordicbrainexNordicneurolab · 2014
- Descendant · cites it directly · 4 of its ownK171754 NovaPACSNovarad Corporation · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK231662 Aid-UIaid · 2024
- Descendant · 2 generations on · 1 of its ownK221796 Cyware 4H and Cysart 4HAbys Medical · 2022
- Descendant · 3 generations on · 0 of its ownK250039 HPACSHealthhub · 2025
- Descendant · 3 generations on · 0 of its ownK243069 Lumys (V1)Intradys · 2025
Most influential descendants
Showing 5 of 5 · See all- K171754NovaPACSNovarad Corporation · 2017 · cites it directly4descendants
- K231662Aid-UIaid · 2024 · 2 generations on1descendant
- K221796Cyware 4H and Cysart 4HAbys Medical · 2022 · 2 generations on1descendant
- K250039HPACSHealthhub · 2025 · 3 generations on0descendants
- K243069Lumys (V1)Intradys · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −2 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −1 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| 0 (this device) | K133910 | Nordicbrainex | Nordicneurolab | 2014 | — |
| +1 | K171754 | NovaPACS | Novarad Corporation | 2017 | 1 |
| +2 | K231662 | Aid-U | Iaid | 2024 | — |
| +2 | K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022 | — |
| +3 | K250039 | HPACS | Healthhub | 2025 | — |
| +3 | K243069 | Lumys (V1) | Intradys | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K090546 | Modification to Nordicice SoftwareSummary page 1…1 Panel: Radiology Product Code: LLZ Predicate device name: Nordic Image Control and Evaluation (nordicCE) Software K090546 Device Description The nordidBrainEx Software is a post-processing application for dynamic MRI data developed with focus on eas… | 2009 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171754 | NovaPACS | 2017 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 16, 2022 | Class II | Z-1462-2022 | Software design | When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped. |
| Sep 17, 2014 | Class II | Z-2050-2018 | Software design | An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K171754 (Novarad Corporation, 2017) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K090546.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
nordicBrainEx provides analysis and visualization capabilities of dynamic MRI data of the brain,
presenting the derived properties and parameters in a clinically useful context.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133910: Nordicbrainex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133910
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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