510(k) · Cleared
ClearedBrainomix 360 e-CTP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainomix Limited · LLZ System, Image Processing, Radiological
Cleared on Jun 1, 2023 as substantially equivalent to K121447 (Ischemaview, Inc., 2013) after a 185-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- Jun 1, 2023
- Review
- 185 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K896095 (1990). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations between
- 3 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 2 generations backK120196 Olea SphereOlea Medical · 2012
- 1 generation backK121447 Ischema View RapidIschemaview, Inc. · 2013
- This deviceK223555 Brainomix 360 e-CTPBrainomix Limited · 2023
Show all 11 generations
- Root · 11 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 10 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 9 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 8 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 7 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 6 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 5 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 4 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 3 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 2 generations backK120196 Olea SphereOlea Medical · 2012
- 1 generation backK121447 Ischema View RapidIschemaview, Inc. · 2013
- This deviceK223555 Brainomix 360 e-CTPBrainomix Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −10 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −9 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −8 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −7 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −6 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −5 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −4 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −3 | K111161 | Perfscape V2.0 | Olea Medical | 2011 | — |
| −2 | K120196 | Olea Sphere | Olea Medical | 2012 | — |
| −1 | K121447 | Ischema View Rapid | Ischemaview, Inc. | 2013 | — |
| 0 (this device) | K223555 | Brainomix 360 e-CTP | Brainomix Limited | 2023 | — |
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 |
|---|---|---|---|
| * | K121447 | Ischema View RapidSummary page 4…Code: LLZ Regulation No.: 21 § CFR 892.2050 Classification Panel: Radiology Predicate Device: Primary: RAPID (K121447) Reference Device: Viz CTP (K180161) Device Description Brainomix 360 e-CTP software allows for visualization of… | 2013 |
| † | K180161 | Viz CTP | 2018 |
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 33 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 8 other devices also cite its predicate K121447.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Brainomix 360 e-CTP is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. This includes DICOM files uploaded through a web…
Read the full statement (124 words)
Brainomix 360 e-CTP is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.
The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. This includes DICOM files uploaded through a web browser interface.
Brainomix 360 e-CTP provides viewing and analysis capabilities for imaging datasets acquired with CT Perfusion.
The CT Perfusion analysis capabilities are for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223555 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223555: Brainomix 360 e-CTP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223555
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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