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MAGBODY DT-600

by Durtech System Corp. 510(k)

Active United States

510(k) K053284

Overview

The MAGBODY DT-600 is a medical device classified under 21 CFR 890.5850, intended for use in neurology applications. It is designed to provide a specific function related to its device type, as defined by regulatory authorities.

The device is supplied as a single-use item and is not reusable. It is manufactured by Durtech System Corp. and has received FDA 510(k) clearance under K053284. The device is not MRI safe, and no specific storage conditions are provided in the specifications.

AI-generated from registry data, 6 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 NumberK053284 Date10 Mar 2006ClearedStatusActive

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
GZJ
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Durtech System Corp.

Questions

  • What is the MAGBODY DT-600 used for?

    The MAGBODY DT-600 is a medical device classified under 21 CFR 890.5850, specifically designed for neurology applications. It provides a specific function as defined by regulatory authorities for neurological procedures.

  • Is the MAGBODY DT-600 reusable or single-use?

    The MAGBODY DT-600 is supplied as a single-use medical device and is not intended for reuse. This design ensures patient safety and device performance for each individual application.

  • What regulatory approvals does the MAGBODY DT-600 have?

    The MAGBODY DT-600 has received FDA 510(k) clearance under number K053284. It was classified as substantially equivalent to predicate devices in the neurology product code category GZJ.

  • Is the MAGBODY DT-600 MRI safe?

    The MAGBODY DT-600 is not MRI safe. This means it should not be used in MRI environments as it may pose safety risks or interfere with the imaging process.