K243428
- 510(k) number
- K243428
- Device name
- e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
- Applicant
- Dxtx Medical, Inc. PA · US
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2025-07-17
- Date received
- 2024-11-05
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243428.pdf
Official FDA record: K243428
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.