# K213891: RealNow

- Pathway: 510(k) (Traditional)
- Applicant: Yiwei Medical Technology Co., Ltd.
- Decided: Feb 24, 2023 after 437 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 11 generations back to K896095 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121447: Ischema View Rapid, Ischemaview, Inc. (2013) Summary page 6.

## Indications for use
RealNow is an image processing software package to be used by trained professionals including physicians. 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, analysis and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM compliant imaging devices. RealNow provides viewing, analysis and communication capabilities for functional and dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated in the standard DICOM format and may be viewed on existing radiological imaging viewers.

Source page: https://510kreport.com/device/K213891
Methodology: https://510kreport.com/methodology