510(k) · Cleared
ClearedCerebralGo Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yukun (Beijing) Technology Co., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Apr 13, 2023 as substantially equivalent to K192692 (Brainomix Limited, 2020) after a 479-day review. Its family tree reaches back 13 generations to 1990.
- Decided
- Apr 13, 2023
- Review
- 479 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K896095 (1990). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations between
- 3 generations backK121447 Ischema View RapidIschemaview, Inc. · 2013
- 2 generations backK172477 iSchemaView RAPIDIschemaview, Inc. · 2018
- 1 generation backK192692 Brainomix 360 e-CTABrainomix Limited · 2020
- This deviceK213986 CerebralGo PlusYukun (Beijing) Technology Co., Ltd. · 2023
Show all 13 generations
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 12 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 11 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 10 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 9 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 8 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 7 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 6 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 5 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 4 generations backK120196 Olea SphereOlea Medical · 2012
- 3 generations backK121447 Ischema View RapidIschemaview, Inc. · 2013
- 2 generations backK172477 iSchemaView RAPIDIschemaview, Inc. · 2018
- 1 generation backK192692 Brainomix 360 e-CTABrainomix Limited · 2020
- This deviceK213986 CerebralGo PlusYukun (Beijing) Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −12 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −11 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −10 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −9 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −8 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −7 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −6 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −5 | K111161 | Perfscape V2.0 | Olea Medical | 2011 | — |
| −4 | K120196 | Olea Sphere | Olea Medical | 2012 | — |
| −3 | K121447 | Ischema View Rapid | Ischemaview, Inc. | 2013 | — |
| −2 | K172477 | iSchemaView RAPID | Ischemaview, Inc. | 2018 | — |
| −1 | K192692 | Brainomix 360 e-CTA | Brainomix Limited | 2020 | — |
| 0 (this device) | 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 |
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K192692 | Brainomix 360 e-CTASummary page 4…CATE DEVICE Table 1 Predicate device information 510(k) Number Product Code Trade Name Manufacturer K192692 LLZ Brainomix 360°e-CTA Brainomix Limited This predicate device has not been subject t… | 2020 |
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 9 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 14 ancestors have a recall of any class.
- 2 other devices also cite its predicate K192692.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
CerebralGo Plus 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 and can be used for image
viewing and processing. Data and images are acquired through DICOM compliant imaging devices.
CerebralGo Plus provides viewing and processing capabilities for imaging datasets acquired with adult's CTA (CT
Angiography).
CerebralGo Plus is not intended for primary diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213986 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213986: CerebralGo Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213986
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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