Elscint Exel 2400E CT Scanner

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

Full name

Elscint's Exel 2400E CT Scanner

510(k) Number

K894542 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

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 primary clinical use of the Elscint Exel 2400E?

  The Elscint Exel 2400E is a computed tomography scanner intended for use in radiology departments to perform diagnostic imaging procedures. Its primary function is to visualize the internal structures of the human body for diagnostic purposes.

• What is the regulatory status of this CT scanner?

  The Elscint Exel 2400E CT Scanner received FDA 510(k) clearance under submission number K894542. It is classified as a Class II device under product code JAK, which relates to computed tomography X-ray systems.

• Who is the manufacturer of the Exel 2400E?

  The device is manufactured by Elscint, Inc., located in Hackensack, New Jersey. The company submitted the device for regulatory review, resulting in a decision of substantial equivalence in 1989.