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Magnetom Systems I-Class and T-Class Releases

by Siemens Medi Cal Solutions, Inc. 510(k)

Active United States

510(k) K062454

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062454 Date3 Nov 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Magnetom Systems I-Class and T-Class releases are magnetic resonance diagnostic devices designed to produce cross-sectional images, including transverse, sagittal, coronal, and oblique views. These systems also generate spectroscopic images and spectra to display the internal structure and function of the head, body, or extremities.

This device is supplied as a software and hardware upgrade for existing Magnetom systems. It is regulated under FDA 510(k) clearance K062454 and is classified as a nuclear magnetic resonance imaging system. The device labeling includes instructions for use, cautions, and warnings to support safe operation.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Magnetom Systems I-Class and T-Class releases?

    These systems are designed to produce cross-sectional images, including transverse, sagittal, coronal, and oblique views. They also generate spectroscopic images and spectra to assist in displaying the internal structure and function of the head, body, or extremities.

  • How is this device supplied to clinical facilities?

    The device is supplied as a comprehensive software and hardware upgrade package intended for installation on existing Magnetom magnetic resonance imaging systems.

  • What regulatory oversight applies to these systems?

    These systems are regulated under FDA 510(k) clearance K062454 and are classified as nuclear magnetic resonance imaging systems. The clearance indicates the device has been found substantially equivalent to existing predicate devices.

  • Are there specific safety instructions for operating these systems?

    Yes, the device labeling includes specific instructions for use, as well as necessary cautions and warnings, to ensure the safe operation of the magnetic resonance imaging equipment.