MR-Guide 2000

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

510(k) Number

K013150 ↗

FDA Product Code

LNH

FDA applicant

Ultraguide , Ltd.

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Ultraguide CT-Guide 1010

  Class II

  FDA 510(k) K002258 Active Cleared 8 Aug 2000

• Ultraguide Ctg 2000SA

  Class II

  FDA 510(k) K022354 Active Cleared 13 Aug 2002

• Ultraguide MR-Guide 3000

  Class II

  FDA 510(k) K011418 Active Cleared 24 May 2001

• Usg 2000SA

  Class II

  FDA 510(k) K023227 Active Cleared 22 Oct 2002

• Ultraguide 1000

  Class II

  FDA 510(k) K974432 Active Cleared 9 Feb 1998

• What is the MR-Guide 2000 used for?

  The MR-Guide 2000 is a guiding system designed specifically for interventional radiology procedures within MRI-compatible environments. It overlays real-time graphical representations of instrument positioning and trajectory onto MRI scans displayed on a personal computer monitor. This helps radiologists and interventional specialists achieve greater spatial awareness and precision during procedures, ensuring accurate placement of tools within MRI settings.

• Is the MR-Guide 2000 a reusable or single-use device?

  The MR-Guide 2000 is supplied as a reusable system. While the data does not specify its sterility status, it is intended for integration with existing MRI systems and adheres to regulatory standards for reuse in clinical settings. Compatibility with MRI equipment is a key requirement for its use.

• How does the MR-Guide 2000 integrate with MRI systems?

  The MR-Guide 2000 is designed to integrate seamlessly with existing MRI systems, ensuring compatibility for use in MRI-compatible environments. It overlays graphical guidance onto MRI images displayed on a personal computer, allowing clinicians to visualize and direct interventional instruments with enhanced precision. The system adheres to regulatory standards, including 21 CFR 892.1000, to ensure safe and effective operation within MRI settings.

• What regulatory approval does the MR-Guide 2000 hold?

  The MR-Guide 2000 holds FDA 510(k) clearance under the reference number K013150. It was reviewed by the Radiology Advisory Committee and classified as substantially equivalent to a predicate device. This clearance confirms its compliance with U.S. regulatory requirements for use in interventional radiology within MRI environments.

• What medical specialty is the MR-Guide 2000 intended for?

  The MR-Guide 2000 is specifically intended for use in radiology, particularly for interventional radiology procedures. It assists clinicians in performing precise interventions within MRI environments by providing real-time visual guidance, making it a specialized tool for radiologists and interventional specialists.