Gyrex 2T-DLX

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

510(k) Number

K915601 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• 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 Gyrex 2T-DLX used for?

  The Gyrex 2T-DLX is a Class II Nuclear Magnetic Resonance Imaging system designed for use in radiology departments to perform diagnostic imaging procedures. It has a field strength of 2 Tesla and is supplied as a complete imaging system for clinical settings.

• How is the Gyrex 2T-DLX supplied?

  The device is supplied as a complete imaging system, including all necessary components for operation in clinical settings. It is manufactured by Elscint, Inc. and intended for use in radiology departments for diagnostic imaging procedures.

• What is the regulatory status of the Gyrex 2T-DLX?

  The Gyrex 2T-DLX received FDA 510(k) clearance on February 14, 1992, with the product code LNH. It was determined to be substantially equivalent to other legally marketed devices and is classified as a Class II medical device.

• What are the specifications of the Gyrex 2T-DLX?

  The Gyrex 2T-DLX is a Nuclear Magnetic Resonance Imaging system with a field strength of 2 Tesla. It is designed for diagnostic imaging procedures in radiology departments and is supplied as a complete system for clinical use.