510(k) · Cleared
ClearedBrainance MD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advantis Medical Imaging Single Member P.C. · LLZ System, Image Processing, Radiological
Cleared on Oct 14, 2021 as substantially equivalent to K163324 (Nordicneurolab AS, 2017) after a 386-day review. Its family tree reaches back 9 generations to 1990. 1 later device descends from it.
- Decided
- Oct 14, 2021
- Review
- 386 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K896095 (1990). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK202808 Brainance MDAdvantis Medical Imaging Single Member P.C. · 2021
- Descendant · cites it directly · 0 of its ownK222975 Advantis PlatformAdvantis Medical Imaging Single Member P.C. · 2023
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 deviceK202808 Brainance MDAdvantis Medical Imaging Single Member P.C. · 2021
Most influential descendants
Showing 1 of 1 · See all- K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C. · 2023 · cites it directly0descendants
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) | K202808 | Brainance MD | Advantis Medical Imaging Single Member P.C. | 2021 | — |
| +1 | K222975 | Advantis Platform | Advantis Medical Imaging Single Member P.C. | 2023 | — |
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 |
|---|---|---|
| 2023 | 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…e management and processing system Classification Regulation: 21 CFR 892.2050 Class : II Panel : Radiology Product Code : LLZ Predicate Device Primary Predicate : K163324, nordicBrainEx This predicate has not been subject to a recall. Reference Device Name 1 : K090546, nordicICE Software This ref… | 2017 |
| † | K090546 | Modification to Nordicice Software | 2009 |
| † | K162513 | Arterys Software v2.0 | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222975 | Advantis Platform | 2023 | 0 |
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 31 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.
- Of its descendants, K222975 (Advantis Medical Imaging Single Member P.C., 2023) has gone furthest, with 0 descendants of its own.
- 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. 2021, 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?
Brainance MD 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202808: Brainance MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202808
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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