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1989 Software Revision to the Bmt-1100

by Bruker Medical Imaging, Inc. 510(k)

Active United States

510(k) K894714

Overview

This device is a Nuclear Magnetic Resonance Imaging System (MRI), classified under the FDA’s product code LNH. As a substantially equivalent revision to the BMT-1100, it generates detailed images of internal body structures using magnetic resonance technology, enabling diagnostic evaluation in radiology. The system operates within the constraints of Class II medical devices, adhering to regulatory standards for safety and performance in MRI applications.

The BMT-1100 Software Revision is intended for use in radiology departments as a diagnostic tool. It is a reusable device, supplied as part of an MRI system and subject to regulatory oversight under 21 CFR 892.1000. No specific sterility requirements are noted, but it must comply with MRI safety standards to ensure compatibility with the imaging environment. The revision was granted FDA 510(k) clearance (K894714) in 1989 under the Traditional 510(k) pathway, with no additional context on size or storage provided in the regulatory data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK894714 Date15 Nov 1989ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Bruker Medical Imaging, Inc.

Questions

  • What is the 1989 software revision for the BMT-1100 used for?

    This software revision enhances the BMT-1100 Nuclear Magnetic Resonance Imaging (MRI) system to generate detailed images of internal body structures. It is designed for diagnostic evaluation in radiology departments, improving the clarity and accuracy of MRI scans for clinicians.

  • Is the BMT-1100 MRI software revision a single-use or reusable device?

    The BMT-1100 MRI system, including this software revision, is a reusable device. It is integrated into the MRI system infrastructure and not intended for single-use disposal. Proper maintenance and compliance with MRI safety standards are required for continued use.

  • Are there any sterility requirements for the BMT-1100 MRI software revision?

    The regulatory data does not specify sterility requirements for the software revision itself, as it is part of a reusable MRI system. However, the entire MRI system must adhere to MRI safety standards to ensure compatibility with the imaging environment and patient safety.

  • What regulatory pathway was followed for the 1989 software revision?

    The 1989 software revision for the BMT-1100 received FDA clearance under the Traditional 510(k) pathway, with clearance number K894714. This pathway demonstrates that the revision is substantially equivalent to legally marketed devices in terms of safety and performance.

  • How is the BMT-1100 MRI system supplied, and what should be considered for storage?

    The BMT-1100 MRI system, including this software revision, is supplied as part of an integrated MRI system and is not intended for standalone use. Storage requirements are not explicitly detailed in the regulatory data, but the system must be stored in a controlled environment that meets MRI safety standards, including electromagnetic interference protection and proper temperature conditions.