i_ Field 1.5T Superconducting Magnetic Resonance Imaging System

FDA 510(k) K221025 · Mri Division,Beijing Wandong Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK221025

Submission

Device name
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
Applicant
Mri Division,Beijing Wandong Medical Technology Co., Ltd.
Beijing, CN
Received
April 6, 2022
Decision date
July 1, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LNH – System, Nuclear Magnetic Resonance Imaging
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1000
Specialty
Radiology

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Questions and answers

When was i_ Field 1.5T Superconducting Magnetic Resonance Imaging System cleared by the FDA?

i_ Field 1.5T Superconducting Magnetic Resonance Imaging System (K221025) received a 510(k) decision of Substantially Equivalent on July 1, 2022, 86 days after the submission was received.

What is the product code of K221025?

The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.