# K253421: Perfusion Measurement Platform v1

- Pathway: 510(k) (Traditional)
- Applicant: Quantified Imaging Limited
- Decided: Jun 22, 2026 after 264 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: 13 generations back to K971684 (1997). 49 ancestors in all.
No later device cites it as a predicate yet.
3 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211059: CereFlow™ V1.2, Translational Mri, LLC (2023) Summary page 5.

## Indications for use
The Perfusion Measurement Platform (PMP) v1 is an image processing software device to be used by trained professionals including but not limited to physicians and medical technicians. The software is hosted on a cloud platform and can be used to perform medical image processing. Data and images are acquired through connection to DICOM compliant imaging devices and modalities. PMP v1 provides automatic semi-quantitative quantification of Arterial Spin Labelling (ASL) data acquired from Magnetic Resonance Imaging (MRI) scanners at 1.5T and 3.0T. PMP v1 is able to process single-delay and multi-delay ASL data from SIEMENS XA31+, GE 3D ASL scanners to generate multiple perfusion parameters (Relative Cerebral Blood Flow/relCBF, Arterial Transit Time/ATT) and exports the results of ASL image analysis as DICOM images.

Source page: https://510kreport.com/device/K253421
Methodology: https://510kreport.com/methodology