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FDA 510(k)

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

K-Number: K243428 · 2025-07-17

ApplicantDxtx Medical, Inc.
Decision Date2025-07-17
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is the device name listed in this FDA 510(k) record. The listed applicant is Dxtx Medical, Inc.. It received FDA 510(k) clearance on 2025-07-17 under 510(k) number K243428. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Dxtx Medical, Inc.. The 510(k) number is K243428.

When did e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector receive FDA 510(k) clearance?

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector received FDA 510(k) clearance on 2025-07-17, under 510(k) number K243428.

Who is the listed applicant for e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector?

The FDA 510(k) record lists Dxtx Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector?

The FDA product code for e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is MOS.

Other records listing Dxtx Medical, Inc. as applicant

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Official Source

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