# K232361: Promaxo MRI System II

- Pathway: 510(k) (Special)
- Applicant: Promaxo, Inc.
- Decided: Sep 5, 2023 after 29 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K073457 (2008). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202518: Promaxo MRI System, Promaxo, Inc. (2021) Summary page 4.

## Indications for use
The Promaxo Magnetic Resonance Imaging (MRI) System Il is an office-based MRI system for producing images that display the prostate and adjoining tissues. When used by a trained urologist or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions under MR guidance in alignment with the current standard of care. Promaxo MR images are not intended to be used for diagnostic purposes, and either a 1.5T or 3T MR image acquired without an endorectal coil is a required input for guidance using the Promaxo MRI System.

Source page: https://510kreport.com/device/K232361
Methodology: https://510kreport.com/methodology