# K213986: CerebralGo Plus

- Pathway: 510(k) (Traditional)
- Applicant: Yukun (Beijing) Technology Co., Ltd.
- Decided: Apr 13, 2023 after 479 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K896095 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192692: Brainomix 360 e-CTA, Brainomix Limited (2020) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K213986
Methodology: https://510kreport.com/methodology