510(k) · Cleared
ClearedBrainomix 360 e-CTA
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 May 28, 2020 as substantially equivalent to K172477 (Ischemaview, Inc., 2018) after a 245-day review. Its family tree reaches back 12 generations to 1990. 3 later devices descend from it.
- Decided
- May 28, 2020
- Review
- 245 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K896095 (1990). 13 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations between
- 3 generations backK120196 Olea SphereOlea Medical · 2012
- 2 generations backK121447 Ischema View RapidIschemaview, Inc. · 2013
- 1 generation backK172477 iSchemaView RAPIDIschemaview, Inc. · 2018
- This deviceK192692 Brainomix 360 e-CTABrainomix Limited · 2020
- Descendant · cites it directly · 0 of its ownK241975 Serv Medical CDSSServ Medical Pte., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242123 Brainomix 360 e-CTABrainomix Limited · 2025
- Descendant · cites it directly · 0 of its ownK213986 CerebralGo PlusYukun (Beijing) Technology Co., Ltd. · 2023
Show all 12 generations
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 11 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 10 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 9 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 8 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 7 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 6 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 5 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 4 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 3 generations backK120196 Olea SphereOlea Medical · 2012
- 2 generations backK121447 Ischema View RapidIschemaview, Inc. · 2013
- 1 generation backK172477 iSchemaView RAPIDIschemaview, Inc. · 2018
- This deviceK192692 Brainomix 360 e-CTABrainomix Limited · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −11 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −10 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −9 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −8 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −7 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −6 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −5 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −4 | K111161 | Perfscape V2.0 | Olea Medical | 2011 | — |
| −3 | K120196 | Olea Sphere | Olea Medical | 2012 | — |
| −2 | K121447 | Ischema View Rapid | Ischemaview, Inc. | 2013 | — |
| −1 | K172477 | iSchemaView RAPID | Ischemaview, Inc. | 2018 | — |
| 0 (this device) | K192692 | Brainomix 360 e-CTA | Brainomix Limited | 2020 | — |
| +1 | K241975 | Serv Medical CDSS | Serv Medical Pte., Ltd. | 2025 | — |
| +1 | K242123 | Brainomix 360 e-CTA | Brainomix Limited | 2025 | — |
| +1 | K213986 | CerebralGo Plus | Yukun (Beijing) Technology Co., Ltd. | 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 |
| 2025 | 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 |
|---|---|---|---|
| * | K172477 | iSchemaView RAPIDSummary page 4…-CTA is Substantially Equivalent to the following Legally Marketed device: Predicate Devices 510(k) Number Trade Name Manufacturer K172477 iSchemaView RAPID iSchemaView Inc Indications for Use Brainomix 360° e-CTA is an image proc… | 2018 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K241975 (Serv Medical Pte., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K172477.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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-CTA 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 standard “off-the-shelf” hardware (physical or virtualized) and can be used to perform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices.
Brainomix 360° e-CTA provides viewing and analysis capabilities for imaging datasets acquired with CTA (CT Angiography).
Brainomix 360° e-CTA is not intended for mobile diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192692: Brainomix 360 e-CTA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192692
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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