Gyrex

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

Generic Name

System, nuclear magnetic resonance imaging

PMA Number

P840007 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

APPR Approved

PMA Supplement

S003 (Normal 180 Day Track)

• Gyrex 2T Prestige Model No. 100-6321-0107 and Gyrex Privilege Model No. 100-6326-0102

  Class II

  FDA 510(k) K965044 Active Cleared 16 Jun 1997

• Head and Neck Coil for the Gyrex 2T-Dlx

  Class II

  FDA 510(k) K943320 Active Cleared 29 Nov 1994

• Dynex-44 Diagnostic Ultrasound Imaging

  Class II

  FDA 510(k) K812014 Active Cleared 16 Sep 1981

• Gyrex Privilege

  Class II

  FDA 510(k) K954039 Active Cleared 24 Nov 1995

• 2T Prestige(100-6321-0107)/Privilege(100-6326-0102)/Gyrex V-Ep(100-6327-0101)

  Class II

  FDA 510(k) K972592 Active Cleared 15 Sep 1997

• Ultrasound Equipment Model Sdl-100A

  Not classified

  FDA 510(k) K837084 Active Cleared 28 Apr 1983

See all devices from Elscint, Inc. →

• What is the primary purpose of the Gyrex System in a clinical setting?

  The Gyrex System is a Nuclear Magnetic Resonance Imaging (MRI) device designed specifically for diagnostic radiology. It uses magnetic fields and radio waves to generate high-resolution images of internal body structures, allowing clinicians to evaluate anatomical and pathological conditions with precision. This makes it essential for assessing soft tissues, organs, and other internal features in MRI-compatible environments.

• How is the Gyrex System supplied and what type of maintenance does it require?

  The Gyrex System is supplied as a reusable medical device, meaning it is intended for repeated use within a radiology department. Proper installation, calibration, and maintenance are required to ensure optimal performance and safety. These tasks should be carried out by trained personnel following the manufacturer’s guidelines to comply with regulatory standards.

• What regulatory pathway was followed for the approval of the Gyrex System?

  The Gyrex System was authorized under the FDA’s Premarket Approval (PMA) process, specifically granted PMA number P840007. This pathway is typically used for higher-risk medical devices, and the system is classified as a Class II device under regulation number 892.1000, indicating it has undergone rigorous review for safety and effectiveness.

• Is the Gyrex System compatible with all MRI environments, or are there specific requirements?

  The Gyrex System is designed for use in MRI-compatible environments, meaning it must be installed in settings where electromagnetic interference is controlled and where safety protocols for MRI operations are strictly followed. The system requires proper shielding and adherence to manufacturer specifications to ensure safe and accurate imaging.

• What does the product code LNH indicate about the Gyrex System’s regulatory classification?

  The product code LNH categorizes the Gyrex System under the FDA’s Product Classification Database as a Nuclear Magnetic Resonance Imaging System. This classification aligns with its intended use in diagnostic radiology and reflects its regulatory filing route, though it does not describe clinical indications. The code is an administrative identifier used for tracking submissions and compliance.