510(k) · Cleared
ClearednordicDSC
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 Mar 3, 2022 as substantially equivalent to K090546 (Nordicimaginglab AS, 2009) after a 188-day review. Its family tree reaches back 8 generations to 1990. 2 later devices descend from it.
- Decided
- Mar 3, 2022
- Review
- 188 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 9 ancestors in all. 2 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 deviceK212720 nordicDSCNordicneurolab AS · 2022
- Descendant · cites it directly · 1 of its ownK241608 nordicMEDiVANordicneurolab AS · 2024
- Descendant · 2 generations on · 0 of its ownK243209 nordicMEDiVANordicneurolab AS · 2024
Most influential descendants
Showing 2 of 2 · See allView 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) | K212720 | nordicDSC | Nordicneurolab AS | 2022 | — |
| +1 | K241608 | nordicMEDiVA | Nordicneurolab AS | 2024 | — |
| +2 | K243209 | nordicMEDiVA | Nordicneurolab AS | 2024 | — |
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 |
|---|---|---|
| 2024 | 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 4…II Panel: Radiology Product Code: LLZ Predicate device name: Nordic Image Control and Evaluation (nordicICE) Software (K090546) Device Description nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynami… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241608 | nordicMEDiVA | 2024 | 1 |
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 32 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, K241608 (Nordicneurolab AS, 2024) has gone furthest, with 1 descendant 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. 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?
nordicDSC is a medical image post-processing software for the analysis of the dynamic time course of the dynamic susceptibility contrast (DSC) enhanced MR data of the human brain to be used by trained professionals such as physicians, radiologists, and medical technicians to yield information useful in clinical applications.
The software is intended to be used off-line and in combination with a DICOM handling platform that can allow for user interactions, sending, receiving, and viewing of data, data quality control, and connection to network.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212720 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212720: nordicDSC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212720
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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