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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 a medical device manufactured by Dxtx Medical, Inc.. It received FDA 510(k) clearance on 2025-07-17 under approval 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. It is manufactured by Dxtx Medical, Inc.. The 510(k) number is K243428.

When was e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector approved by the FDA?

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 approval number K243428.

What company makes 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 manufactured by Dxtx Medical, Inc..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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