# K210843: STAGE

- Pathway: 510(k) (Traditional)
- Applicant: Spintech, Inc.
- Decided: Jun 29, 2021 after 99 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: 10 generations back to K971684 (1997). 34 ancestors in all.
1 later device descends from it; 1 cites it directly.
9 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181093: SyMRI, Syntheticmr AB (2018) Summary page 4.
- K173224: Spin-Swi, Spintech, Inc. (2018) Summary page 4.

## Most influential descendants
- K223079: Stage (2022), 0 descendants of its own

## Indications for use
STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced Tl weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of Tl, R2*, and proton density (PD). When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis. STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition ( e.g., T2 FLAIR).

Source page: https://510kreport.com/device/K210843
Methodology: https://510kreport.com/methodology