Pediatric Head-Spine Coil (Model 5000012701)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Pediatric Head-Spine Coil EUDAMEDPhilips FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Pediatric Head-Spine Coil EUDAMEDPediatric NV Spine coil 1.5T 8ch FDA UDI
- Model / Reference
- 4522-150-41161 EUDAMEDFDA UDI
- Description
- Pediatric NV Spine coil 1.5T 8ch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970564410062 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970564410062 EUDAMED
- FDA Product Code
- MOS FDA 510(k)FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)FDA UDI
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The Pediatric Head-Spine Coil (Model 5000012701) is a receive-only magnetic resonance imaging (MRI) coil designed specifically for pediatric patients. It is classified as a specialty coil and is intended for obtaining high-quality diagnostic images of the head and spine in MRI systems.
This coil is supplied as a reusable device and is compatible with MRI systems, including the Philips Achieva 3.0T system. It has received FDA 510(k) clearance and complies with the Medical Device Directive (MDD), indicating its regulatory approval for use in radiology settings. The coil is intended for professional use in clinical environments and requires proper handling and maintenance as per manufacturer guidelines.
Frequently asked questions
Is this coil designed for single-use or can it be reused in a clinical setting?
The Pediatric Head-Spine Coil (Model 5000012701) is explicitly described as a reusable device. Since it is intended for professional use in clinical environments, it requires proper handling and maintenance as outlined by the manufacturer to ensure performance and safety over multiple uses.
What MRI systems is this coil compatible with, and does it have any specific model requirements?
The coil is designed for compatibility with MRI systems, with a specific mention of the Philips Achieva 3.0T system. While the data does not list all compatible systems, the manufacturer’s guidelines should confirm additional MRI system compatibility. Always verify system compatibility before use.
How is this coil regulated, and what approvals does it hold?
The coil holds FDA 510(k) clearance (K101858) and complies with the Medical Device Directive (MDD). These approvals indicate it meets regulatory standards for use in radiology settings in the U.S. and EU, respectively. The device is classified under FDA Class II and falls under the Radiology advisory committee.
What should clinicians consider when storing or maintaining this reusable coil?
Since the coil is reusable, proper storage and maintenance are critical to preserve its performance and sterility. While the data does not specify storage conditions, reusable MRI coils typically require cleaning, calibration, and storage in a clean, dry environment to prevent contamination or damage. Always follow the manufacturer’s instructions for cleaning and maintenance protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 (K101858) — FDA 510(k ..., PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 - fda.report, fda.innolitics.com, Shanghai Chenguang Pediatric Head-Spine Coil ( :5000012701
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101858 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai Chenguang Medical Technologies Co., Ltd
- FDA Applicant
- Shanghai Chenguang Medical Technologies Co, Ltd.
Sources (3)
- FDA 510(k) K101858 24 fields · synced Oct 6, 2026
- FDA UDI eeeb03e5-6f8b-4dbd-9249-b6a8ee2a54a4 34 fields · synced May 27, 2026
- EUDAMED cded9bc0-de8a-4bf8-b716-b90e98899952 61 fields · synced Jul 15, 2026