# K232981: Synq Software Version 1.3

- Pathway: 510(k) (Traditional)
- Applicant: Synaptive Medical, Inc.
- Decided: Oct 11, 2023 after 20 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: 12 generations back to K971684 (1997). 27 ancestors in all.
No later device cites it as a predicate yet.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200327: Evry, Synaptive Medical, Inc. (2020) Summary page 4.

## Indications for use
The Synq Software is indicated for use in conjunction with Synq, a magnetic resonance diagnostic device (MRDD) that produces axial, sagittal, coronal, and oblique cross-sectional images and displays the internal structure and/or function of the head. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K232981
Methodology: https://510kreport.com/methodology