Skip to content

i_Space 1.5T Superconducting Magnetic Resonance Imaging System

by Mri Division, Beijing Wandong Medical Technology Co., Ltd.

510(k) K192650

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK192650 Date29 Jan 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
FDA applicant
Mri Division,Beijing Wandong Medical Technology Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The i_Space 1.5T Superconducting Magnetic Resonance Imaging System is a superconducting MRI device designed for non-invasive imaging of internal anatomical structures. It generates transverse, sagittal, coronal, and oblique images of the head, body, or extremities using magnetic resonance principles without ionizing radiation, providing detailed physiological and clinical information for diagnostic purposes.

This system is supplied as a complete MRI unit, including hardware, software, and RF coils, and is intended for use in clinical radiology settings. The device is classified under Product Code LNH and holds FDA 510(k) clearance (K192650) as substantially equivalent to a predicate device, with no third-party review. It is not specified as single-use or reusable, but standard MRI safety protocols apply, including MRI-compatible environment requirements. Storage and handling follow manufacturer guidelines for superconducting magnets and electronic components.

Other devices from Mri Division, Beijing Wandong Medical Technology Co., Ltd.