# K173512: MFI-Cardiac

- Pathway: 510(k) (Traditional)
- Applicant: Multifunctional Imaging, LLC
- Decided: Feb 5, 2018 after 84 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: 7 generations back to K913770 (1991). 31 ancestors in all.
No later device cites it as a predicate yet.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101279: CORRIDOR4DM V2010 Model: V2010, Invia (2010) Summary page 4.

## Indications for use
The MFI–Cardiac application is intended to provide processing of rest and stress myocardial perfusion positron emission tomography (PET) images with approved radiotracers that have been acquired with a single-scan or fast back-to-back scans without waiting for radiotracer decay between scans. The application models measurements of tracer uptake over time to aid in the processing of the images. Co-registration or fusion of volumetric data is provided as a quality control. The processed output images are reviewed on other devices by qualified medical professionals trained in the use of medical imaging devices.

Source page: https://510kreport.com/device/K173512
Methodology: https://510kreport.com/methodology