# K222036: MPXA-2000

- Pathway: 510(k) (Traditional)
- Applicant: Medipixel, Inc.
- Decided: Mar 22, 2023 after 254 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: 5 generations back to K896095 (1990). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112807: X-Ray Vva, Medis Medical Imaging Systems BV (2012) Summary page 4.

## Most influential descendants
- K252634: Imagine® Enterprise Suite (2026), 0 descendants of its own

## Indications for use
MPXA-2000 is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the coronary arteries, for use on individual patients with coronary artery disease (CAD). MPXA-2000 is indicated for use in adult patient only. When the quantified results provided by MPXA-2000 are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.

Source page: https://510kreport.com/device/K222036
Methodology: https://510kreport.com/methodology