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3.0T Ingenia Endorectal Coil Interface Device System (eCoil®)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9896-030-19032
Identity
- Trade Name
- 3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) EUDAMED3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) - Philips FDA UDI
- Model / Reference
- 9896-030-19032 EUDAMEDFDA UDI
- Description
- 3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) - Philips FDA UDI
Identifiers
- Catalog Number
- 9896-030-19032 FDA UDI
- Primary DI / UDI-DI
- 00850011472101 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850011472989603019032S5 EUDAMED
- 510(k) Number
- K063342 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018002 MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Medical Purpose
- The purpose of the 3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) is for high-resolution magnetic resonance imaging, including spectroscopy, of the prostate and surrounding pelvic tissue, with the combination of the 3.0T Ingenia Endorectal Coil Interface Device (eCoil®) and the Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®). This system is designed to be used exclusively with the Philips 3.0T Ingenia MRI Scanner System. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA 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
3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) by Dxtx Medical Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850011472989603019032S5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DxTx Medical, Inc.
- EUDAMED SRN
- US-PR-000042604
Sources (2)
- EUDAMED c766794f-a201-4087-9c75-a004e31ad30b 61 fields · synced Jul 16, 2026
- FDA UDI c25bef09-7ced-45e4-a1fe-cf45a3946423 35 fields · synced May 30, 2026