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 Jan 6, 2025 as substantially equivalent to K192692 (Brainomix Limited, 2020) and 1 other predicate after a 171-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Jan 6, 2025
- Review
- 171 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K896095 (1990). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 11 generations between
- 3 generations backK182130 iSchemaView RAPIDIschemaview, Inc. · 2018
- 2 generations backK213165 RapidIschemaview, Inc. · 2022
- 1 generation backK233582 RapidIschemaview, Inc. · 2024
- This deviceK242123 Brainomix 360 e-CTABrainomix Limited · 2025
Show all 15 generations
- Root · 15 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 14 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 13 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 12 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 11 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 10 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 9 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 8 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 7 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 6 generations backK120196 Olea SphereOlea Medical · 2012
- 5 generations backK121447 Ischema View RapidIschemaview, Inc. · 2013
- 4 generations backK172477 iSchemaView RAPIDIschemaview, Inc. · 2018
- 3 generations backK182130 iSchemaView RAPIDIschemaview, Inc. · 2018
- 2 generations backK213165 RapidIschemaview, Inc. · 2022
- 1 generation backK233582 RapidIschemaview, Inc. · 2024
- This deviceK242123 Brainomix 360 e-CTABrainomix Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −14 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −13 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −12 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −11 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −10 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −9 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −8 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −7 | K111161 | Perfscape V2.0 | Olea Medical | 2011 | — |
| −6 | K120196 | Olea Sphere | Olea Medical | 2012 | — |
| −5 | K121447 | Ischema View Rapid | Ischemaview, Inc. | 2013 | — |
| −4 | K172477 | iSchemaView RAPID | Ischemaview, Inc. | 2018 | — |
| −3 | K182130 | iSchemaView RAPID | Ischemaview, Inc. | 2018 | — |
| −2 | K213165 | Rapid | Ischemaview, Inc. | 2022 | — |
| −1 | K233582 | Rapid | Ischemaview, Inc. | 2024 | — |
| 0 (this device) | K242123 | Brainomix 360 e-CTA | Brainomix Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K192692 | Brainomix 360 e-CTASummary page 5…d. Regulation Number: 21 C.F.R. §892.2050 Regulatory Class: Class II Regulation Name: Medical Image Management And Processing System Product Code: LLZ Submission Number: K192692 Trade Name: Rapid (Secondary Predicate) Manufacturer: iSchemaView Regulation Number: 21 C.F.R. §892.2050 Regulatory Class: Class… | 2020 |
| * | K233582 | RapidSummary page 5…gulation Number: 21 C.F.R. §892.2050 Regulatory Class: Class II Regulation Name: Medical Image Management And Processing System Product Code: LLZ, QIH Submission Number: K233582 Page |1… | 2024 |
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 35 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 22 ancestors have a recall of any class.
- 2 other devices also cite its predicate K192692.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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.
Brainomix 360 e-CTA vessel density asymmetry ratio applies only to the MCA region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242123: 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/K242123
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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