e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
FDA 510(k) clearance K243428 · decided 2025-07-17
Clearance details
- K-number
- K243428
- Device name
- e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
- Applicant
- Dxtx Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-05
- Decision date
- 2025-07-17
- Days to decision
- 254 days
- Clearance type
- Abbreviated
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.