ACCESS

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

510(k) Number

K940796 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Opart, Model Mrt-600

  Class II

  FDA 510(k) K991740 Active Cleared 2 Aug 1999

• Mrt 50A Flexible Body Coil

  Class II

  FDA 510(k) K900285 Active Cleared 9 Mar 1990

• Mrt-50

  Class II

  FDA 510(k) K921413 Active Cleared 14 Aug 1992

• Flexart V3.5 Software

  Class II

  FDA 510(k) K970573 Active Cleared 21 Jul 1997

• Mrt 50A Joint Coil

  Class II

  FDA 510(k) K900727 Active Cleared 9 Mar 1990

• Mrt 50A

  Class II

  FDA 510(k) K903770 Active Cleared 20 Nov 1990

See all devices from Toshiba America Mri, Inc. →

• What is the ACCESS device used for?

  ACCESS is a Nuclear Magnetic Resonance Imaging System used in radiology for diagnostic imaging purposes. It is a Class 2 medical device that provides detailed images of internal body structures for medical evaluation.

• Is the ACCESS device single-use or reusable?

  The ACCESS device is supplied as a system and is not specified as single-use or reusable in the provided data. This suggests it is a permanent installation system designed for multiple imaging procedures rather than disposable equipment.

• What regulatory approvals does the ACCESS system have?

  The ACCESS system has FDA 510(k) clearance with product code LNH and is regulated under 892.1000. It was determined to be substantially equivalent to predicate devices and reviewed by the Radiology advisory committee.

• Are there different sizes or models of the ACCESS system available?

  The device data does not specify different sizes or models for the ACCESS system. It appears to be a standardized system configuration without variations in size or specifications mentioned in the provided information.