510(k) · Cleared
ClearednordicMEDiVA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nordicneurolab AS · LLZ System, Image Processing, Radiological
Cleared on Oct 22, 2024 as substantially equivalent to K163324 (Nordicneurolab AS, 2017) and 2 other predicates after a 21-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Oct 22, 2024
- Review
- 21 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K896095 (1990). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations between
- 3 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 2 generations backK163324 nordicBrainExNordicneurolab AS · 2017
- 1 generation backK241608 nordicMEDiVANordicneurolab AS · 2024
- This deviceK243209 nordicMEDiVANordicneurolab AS · 2024
Show all 10 generations
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 8 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 7 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 6 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 5 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 4 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 3 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 2 generations backK163324 nordicBrainExNordicneurolab AS · 2017
- 1 generation backK241608 nordicMEDiVANordicneurolab AS · 2024
- This deviceK243209 nordicMEDiVANordicneurolab AS · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −9 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −8 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −7 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −6 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −5 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −4 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −3 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −2 | K163324 | nordicBrainEx | Nordicneurolab AS | 2017 | — |
| −1 | K241608 | nordicMEDiVA | Nordicneurolab AS | 2024 | — |
| 0 (this device) | K243209 | nordicMEDiVA | Nordicneurolab AS | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2008 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (3)
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 7…21 CFR 807.92(a)(6) nordicMEDiVA has the same technological characteristics as the predicate device nordicBrainEx (K163324). Both the subject device and the predicate device: - Allow for the import and export of MR DICOM images from other DICOM-compli… | 2017 |
| * | K241608 | nordicMEDiVASummary page 7…age analysis manually. The DSC- and BOLD fMRI analysis of the subject device has technological characteristics identical to those of the reference device, nordicMEDiVA (K241608). These differences do not raise additional questions about the safety or effectiveness of the subject device. Non-Clinical and… | 2024 |
| * | K203518 | QuicktomeSummary page 5…I~I L_L_z_ _ _~ I K203518 I I~a_u_ickt_o_m_e_ _....:::::-....:::::-....:::::-....:::::-....:::::-....:::::-....:::::-....:::::-....:::::-… | 2021 |
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 34 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 14 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. 2024, 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?
Intended use The nordicMEDiVA software is an advanced visualization and processing platform with a specific focus on providing algorithms designed to analyze functional and dynamic MRI data of the brain. The software runs on a server in a networked environment and is accessed by users via a standard web browser. It can communicate with other imaging platforms that support DICOM, and process medical image data acquired through DICOM-compliant imaging…
Read the full statement (245 words)
Intended use
The nordicMEDiVA software is an advanced visualization and processing platform with a specific
focus on providing algorithms designed to analyze functional and dynamic MRI data of the brain.
The software runs on a server in a networked environment and is accessed by users via a standard
web browser. It can communicate with other imaging platforms that support DICOM, and process
medical image data acquired through DICOM-compliant imaging devices and modalities.
Intended users
nordicMEDiVA must be operated according to its intended purpose and only by qualified medical
personnel with the necessary knowledge in accordance with country-specific regulations, such as
trained radiological technicians or physicians. Users must have received training in applicable areas,
such as in MR technology and neuroanatomy.
Indications for use
nordicMEDiVA is indicated for image analysis and visualization of functional and dynamic MRI data
of the brain, presenting derived properties and parameters from the input image data in a clinically
useful context.
Contraindications
The software is not be used as an archiving device for patients' image data.
The software is not to be used as a sole basis for clinical decisions, but further evidence has to be
taken into account.
The software is not to be used as a sole basis in emergency care applications.
The software is not to be used for applications other than the analysis and visualization of MR data,
or data derived thereof, of the human brain.
Patient target population
nordicMEDiVA has no limitation concerning the patient population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243209: nordicMEDiVA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243209
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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