510(k) · Cleared
Recalled · Class II · 2023Functional MR V1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olea Medical S.A.S. · LLZ System, Image Processing, Radiological
Cleared on Jul 6, 2022 as substantially equivalent to K163324 (Nordicneurolab AS, 2017) after a 51-day review. Its family tree reaches back 9 generations to 1990. It has been recalled once.
- Decided
- Jul 6, 2022
- Review
- 51 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K896095 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations between
- 3 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 2 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 1 generation backK163324 nordicBrainExNordicneurolab AS · 2017
- This deviceK221426 Functional MR V1.0Olea Medical S.A.S. · 2022
Show all 9 generations
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 7 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 6 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 5 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 4 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 3 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 2 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 1 generation backK163324 nordicBrainExNordicneurolab AS · 2017
- This deviceK221426 Functional MR V1.0Olea Medical S.A.S. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −8 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −7 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −6 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −5 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −4 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −3 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −2 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −1 | K163324 | nordicBrainEx | Nordicneurolab AS | 2017 | — |
| 0 (this device) | K221426 | Functional MR V1.0 | Olea Medical S.A.S. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K163324 | nordicBrainExSummary page 4…ge Management and Processing System Regulatory Class: 21 CFR 892.2050 Product Code: LLZ Predicate Device nordicBrainEx v2.3.7, Manufacturer: NordicNeurolab AS® (K163324) Device Name: nordicBrainEx v2.3.7 Regulation Number: 21 CFR 892.2050 Product Code: LLZ… | 2017 |
| † | K152602 | Olea Sphere V3.0 | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2023 | Class II | Z-0122-2024 | Software design | When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 3 other devices also cite its predicate K163324.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers. Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used…
Read the full statement (140 words)
Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package.
It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers.
Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps.
Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis.
Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images.
When interpreted by a skilled physician, Functional MR V1.0 provides information that may be used in a clinically useful context. Patient management decisions should not be based solely on the results of Functional MR V1.0.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221426: Functional MR V1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221426
Report an extraction error
Are you the manufacturer?
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