FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
K Number: K243428
·
Decision Jul 17, 2025
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
2
Review Days
254
Basic Information
- Device Name
- e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
- K Number
- K243428
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dxtx Medical, Inc.
- Date Received
- November 5, 2024
- Decision Date
- July 17, 2025
- Product Code
- MOS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K223249 | Pro-Tx Endorectal Balloon (PROT-25) | Feb 10, 2023 | Substantially Equivalent |