MRT-35

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

Full name

Mrt-35(Tm)

510(k) Number

K921940 ↗

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 MRT-35 used for in medical practice?

  The MRT-35 is a Class II Nuclear Magnetic Resonance Imaging System used in radiology departments for diagnostic imaging purposes. It helps clinicians visualize internal body structures to aid in diagnosis and treatment planning.

• How is the MRT-35 supplied and what are its regulatory details?

  The device is supplied with various registration numbers and manufactured in S. San Francisco, CA. It received FDA 510(k) clearance with K-number K921940 on April 24, 1992, and is regulated under product code LNH and regulation number 892.1000.

• Is the MRT-35 a single-use device or can it be reused?

  The device is not described as single-use in the provided information. As a diagnostic imaging system, it would be designed for multiple patient examinations following proper sterilization and maintenance protocols according to manufacturer guidelines.

• What sizes and models of the MRT-35 are available?

  The provided information does not specify different sizes or models of the MRT-35 system. The device data only mentions the MRT-35(TM) model without detailing variations in size or configuration.