e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector— 510(k) K243428
Substantially EquivalentDxtx Medical, Inc.
FDA 510(k) clearance K243428 for e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector, Substantially Equivalent on 2025-07-17. Applicant: Dxtx Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Dxtx Medical, Inc.
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Pittsburgh, PA, US
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