CP-Spine Coils for Gyrex 2T-DLX & V-DLX

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

510(k) Number

K934987 ↗

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 CP-Spine Coils device used for?

  The CP-Spine Coils are a system for nuclear magnetic resonance imaging used in radiology, specifically designed as coils for use with Gyrex 2T-DLX and V-DLX MRI systems to support imaging procedures.

• Is the CP-Spine Coils device reusable or single-use?

  The device is supplied as a reusable component for MRI imaging procedures, meaning it can be cleaned and used multiple times following appropriate reprocessing protocols.

• What regulatory clearance does the CP-Spine Coils have?

  The device received FDA 510(k) clearance K934987 on September 16, 1994, under product code LNH and regulation number 892.1000, and is classified as a Class 2 device in the radiology specialty.