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1.5T Ingenia Endorectal Coil Interface Device System (eCoil®)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- 1.5T Ingenia Endorectal Coil Interface Device System (eCoil®) FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 1.5T Ingenia Endorectal Coil Interface Device System (eCoil®) - Philips FDA UDI
- Model / Reference
- 9896-030-19122 FDA UDI
- Description
- 1.5T Ingenia Endorectal Coil Interface Device System (eCoil®) - Philips FDA UDI
Identifiers
- Catalog Number
- 9896-030-19122 FDA UDI
- Primary DI / UDI-DI
- 00850011472088 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
1.5T Ingenia Endorectal Coil Interface Device System (eCoil®) by Dxtx Medical Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as MRI system coil, radio-frequency.
- Dunlee Sentinelle — Philips Medical Systems Nederland B.V. · Class II
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- All-Purpose Arch Adapter — NORAS MRI products GmbH · Class II
- 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.
- 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
- DxTx Medical 1.5T eCoil Imaging Device FRU (for Philips Ingenia) — DXTX MEDICAL INC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dxtx Medical Inc
Sources (2)
- FDA UDI 65a3a1d8-4c3e-48f3-95ee-768d53680508 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026