Identity
- Trade Name
- MEDRAD® 1.5T eCoil Imaging System (for Philips) FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- "PROSTATE eCOIL PHILIPS 1.5T (60727390)" FDA UDI
- Model / Reference
- 4522-132-70681 FDA UDI
- Description
- "PROSTATE eCOIL PHILIPS 1.5T (60727390)" FDA UDI
Identifiers
- Catalog Number
- 4522-132-70681 FDA UDI
- Primary DI / UDI-DI
- 00616258009216 FDA UDI
- 510(k) Number
- K901888 FDA UDI
- FDA Product Code
- LNH 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: MRI system coil, radio-frequency
MEDRAD® 1.5T eCoil Imaging System (for Philips) by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as MRI system coil, radio-frequency.
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- NORAS OR HEADCOIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH · Class II
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Cleared under the same submission
K901888 also covers:
- MEDRAD® Disposable Prostate Coil — Bayer Medical Care Inc.
- MEDRAD® Disposable Prostate Coil — Bayer Medical Care Inc.
- MEDRAD® Disposable Prostate Coil — Bayer Medical Care Inc.
- DxTx Medical 1.5 eCoil Imaging System Disposables (Prostate Bulk 50/bx) — DXTX MEDICAL INC
- DxTx Medical 1.5T eCoil Imaging System Disposables (Prostate - Philips) — 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
- Bayer Medical Care Inc.
Sources (1)
- FDA UDI 2901c8fb-2e5b-45cc-80a4-6c14a4ec3338 36 fields · synced Jun 9, 2026