i_Space 1.5T Superconducting Magnetic Resonance Imaging System— 510(k) K192650

Substantially Equivalent

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

FDA 510(k) clearance K192650 for i_Space 1.5T Superconducting Magnetic Resonance Imaging System, Substantially Equivalent on 2021-01-29. Applicant: Mri Division,Beijing Wandong Medical Technology Co., Ltd..

Clearance details

Applicant: Mri Division,Beijing Wandong Medical Technology Co., Ltd.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2019-09-24
Decision date: 2021-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.