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DxTx Medical 3T eCoil Imaging Device (for Philips)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- DxTx Medical 3T eCoil Imaging Device (for Philips) FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Ecoil ID - 3.0T Philips Ingenia Assy - 9896-030-19031 FDA UDI
- Model / Reference
- 9896-030-19031 FDA UDI
- Description
- Ecoil ID - 3.0T Philips Ingenia Assy - 9896-030-19031 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011472040 FDA UDI
- 510(k) Number
- K063342 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: MRI system coil, radio-frequency
DxTx Medical 3T eCoil Imaging Device (for Philips) by Dxtx Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI system coil, radio-frequency.
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- Operator's Manual Flexibility Siemens — NORAS MRI products GmbH · Class II
- NORAS OR HEADCOIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH · Class II
- ScanMed Long Bone (L) Coil — SCANMED, LLC · Class II
Cleared under the same submission
K063342 also covers:
- MEDRAD® 1.5T eCoil Imaging System (for Philips) — Bayer Medical Care Inc.
- MEDRAD® 1.5T eCoil Interface Device (for Philips) — Bayer Medical Care Inc.
- MEDRAD® 3.0T eCoil Imaging System (for Philips) — Bayer Medical Care Inc.
- MEDRAD® 3.0T eCoil Imaging System (for Philips) — Bayer Medical Care Inc.
- MEDRAD® eCoil Imaging System (for Philips Ingenia) — Bayer Medical Care Inc.
- MEDRAD® eCoil Imaging System (for Philips Ingenia) — Bayer Medical Care Inc.
- MEDRAD® eCoil Imaging System (for Philips Ingenia) — Bayer Medical Care Inc.
- MEDRAD® eCoil Imaging System (for Philips Ingenia) — Bayer Medical Care Inc.
- MEDRAD® eCoil Imaging System (for Philips Ingenia) — Bayer Medical Care Inc.
- 1.5T Ingenia Endorectal Coil Interface Device System (eCoil®) — DXTX MEDICAL INC
- DxTx Medical 1.5 T eCoil Imaging System (For Philips) — DXTX MEDICAL INC
- DxTx Medical 1.5T eCoil Imaging Device FRU (for Philips Ingenia) — DXTX MEDICAL INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dxtx Medical Inc
Sources (1)
- FDA UDI f12ccacf-a3b1-4942-b5d4-848aaa642624 34 fields · synced May 31, 2026