# K192650: i_Space 1.5T Superconducting Magnetic Resonance Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Mri Division,Beijing Wandong Medical Technology Co., Ltd.
- Decided: Jan 29, 2021 after 493 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: 6 generations back to K955249 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052172: HHF1 Magnetic Resonance Imaging System, Hitachi Medical Systems America, Inc. (2005) Summary page 4.

## Most influential descendants
- K221025: i_ Field 1.5T Superconducting Magnetic Resonance Imaging System (2022), 0 descendants of its own

## Indications for use
i_ Space 1.5T Superconducting Magnetic Resonance Imaging System is ao imaging device, wh ich is intended 10 provide the physician with physio logical and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR1 System produces transverse, sagittal, coronal, and oblique images that display the internal structure of the bead, body, or extremities. The images produced by the MRI System reflect the spatial distribution of protons (hydrogen nuclei) exl1ibi1ing magnetic resonance. TI1e NMR propenies that de1em1ine the image appearance are proton density, spin- lattice relaxation time (Tl), spin-spin relaxation time (T2) and flow. When interpreted by a traioed-physician, these images provide infomiation t hat can be useful in diagnosis detemiinatioo.

Source page: https://510kreport.com/device/K192650
Methodology: https://510kreport.com/methodology