# K200327: Evry

- Pathway: 510(k) (Traditional)
- Applicant: Synaptive Medical, Inc.
- Decided: Apr 29, 2020 after 79 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: 11 generations back to K971684 (1997). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121676: 1.5T Signa HDXT 3.0T Signa HDXT Signa Vibrant, Ge Medical Systems, LLC (2012) Summary page 4.

## Most influential descendants
- K232981: Synq Software Version 1.3 (2023), 0 descendants of its own

## Indications for use
Evry is indicated for use as 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/K200327
Methodology: https://510kreport.com/methodology