Resonex RX4000 Magnetic Resonance Imaging System

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Resonex RX4000{TM} Magnetic Resonance Imaging Syst

Generic Name

System, nuclear magnetic resonance imaging

PMA Number

P860062 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

APPR Approved

PMA Supplement

S001 (THIRTY DAY TRACK)

• Version 4.3 Application Software for Use W/Rx-4000

  Class II

  FDA 510(k) K901602 Active Cleared 7 May 1990

• Bo Power Supply

  Class II

  FDA 510(k) K921046 Active Cleared 28 May 1992

• Mobile Rx-4000 Magnetic Resonance Imaging System

  Class II

  FDA 510(k) K894974 Active Cleared 12 Sep 1989

• 2DTOF Magnetic Resonance Angiograph (Mra)

  Class II

  FDA 510(k) K914114 Active Cleared 4 Dec 1991

• Bilateral Tmj Coil

  Class II

  FDA 510(k) K902630 Active Cleared 19 Jul 1990

• ECG Gating Unit

  Class II

  FDA 510(k) K931392 Active Cleared 2 Nov 1993

See all devices from Resonex, Inc. →

• What is the primary use case for the Resonex RX4000 Magnetic Resonance Imaging System in a clinical setting?

  The Resonex RX4000 Magnetic Resonance Imaging System is designed for diagnostic radiology, enabling detailed imaging of internal body structures using magnetic fields and radio waves. Clinicians use it to evaluate anatomical and pathological conditions, making it ideal for radiology departments where MRI capabilities are essential.

• How was the regulatory approval process for this MRI system structured, and what does that tell me about its compliance?

  The Resonex RX4000 received FDA Premarket Approval (PMA) under PMA number P860062, which is the highest level of approval for medical devices in the U.S. This indicates that the device underwent rigorous review by the FDA to ensure its safety, effectiveness, and compliance with regulatory standards before being authorized for market distribution.

• Is the Resonex RX4000 Magnetic Resonance Imaging System intended for single-use or repeated use in clinical environments?

  The provided data does not specify whether the Resonex RX4000 MRI system is designed for single-use or repeated use. MRI systems are generally not classified as single-use devices, as they are intended for long-term, repeated use in clinical settings. For precise usage guidelines, consult the manufacturer’s instructions or maintenance documentation.

• What type of facility or department would typically house this MRI system, and why?

  This MRI system is intended for use in radiology departments or clinical settings where advanced imaging is required. Its design and regulatory classification (Class II) align with the needs of specialized diagnostic environments, such as hospitals or dedicated imaging centers, where detailed anatomical evaluations are performed.