# K211059: CereFlow™ V1.2

- Pathway: 510(k) (Traditional)
- Applicant: Translational Mri, LLC
- Decided: Mar 31, 2023 after 721 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: 12 generations back to K971684 (1997). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152602: Olea Sphere V3.0, Olea Medical (2016) Summary page 7.

## Most influential descendants
- K253421: Perfusion Measurement Platform v1 (2026), 0 descendants of its own

## Indications for use
CereFlow™ V1.2 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 a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. CereFlow™ V1.2 provides visualization and automatic semi-quantitative quantification of Arterial Spin Labeling (ASL) data acquired from Magnetic Resonance Imaging (MRI) scanners at 1.5T and 3.0T. CereFlow™ V1.2 is able to process single-delay and multi-delay ASL data to generate multiple perfusion parameters (Cerebral Blood Flow/CBF, Arterial Transit Time/ATT), and exports the results of ASL image analysis as DICOM images and in a report.

Source page: https://510kreport.com/device/K211059
Methodology: https://510kreport.com/methodology