FDA 510(k) clearance · back to tracker

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector

Dxtx Medical, Inc. cleared K243428 on 2025-07-17, decision: substantially equivalent

K-number

K243428

Sponsor

Dxtx Medical, Inc.

Device

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-07-17

Product code

MOS

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1000

Official FDA record

Open K243428on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.