Model Cg-Whc18-H150-Ap - Wrist Hand Coil 1.5t 4 Ch,
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Wrist/Hand coil EUDAMEDPhilips FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Wrist/Hand coil EUDAMEDWrist-Hand coil 1.5T FDA UDI
- Model / Reference
- 4522-150-41021 EUDAMEDFDA UDI
- Description
- Wrist-Hand coil 1.5T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970564410086 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970564410086 EUDAMED
- 510(k) Number
- 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
This device is a Magnetic Resonance, Specialty Coil designed for wrist and hand imaging at 1.5 Tesla. It features a four-channel configuration to enhance signal reception and improve image quality for radiologic examinations of peripheral extremities.
The coil is intended for use in MRI environments and is supplied as a reusable, non-sterile accessory. It is compatible with 1.5T MRI systems and must be stored in a clean, dry environment to prevent damage. Authorised under FDA 510(k) clearance and the Medical Device Directive (MDD), it adheres to regulatory standards for Class II devices.
Frequently asked questions
What is the primary purpose of this MRI coil, and what type of imaging does it optimize for?
This coil, the MODEL CG-WHC18-H150-AP, is specifically designed for wrist and hand imaging at 1.5 Tesla. Its four-channel configuration enhances signal reception, improving image clarity and detail for radiologic examinations of peripheral extremities like the wrist and hand.
Is this coil reusable or single-use, and what care is required to maintain its condition?
The coil is reusable and non-sterile, meaning it is intended for repeated use within MRI environments. To preserve its functionality, it must be stored in a clean, dry environment to prevent damage from moisture or contamination.
What MRI systems is this coil compatible with, and are there any specific storage requirements?
This coil is compatible with 1.5T MRI systems only. While no explicit storage temperature is mentioned, the manufacturer advises keeping it in a clean, dry environment to avoid degradation or operational issues.
How was this device’s regulatory approval process handled, and what classification does it fall under?
The coil received FDA 510(k) clearance under a Traditional review process, determined to be Substantially Equivalent to a predicate device. It is classified as a Class II medical device under the Medical Device Directive (MDD) and falls under the Radiology specialty category.
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.
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 | K071882 | 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) K071882 24 fields · synced Oct 6, 2026
- FDA UDI 4e2728e2-56b9-400b-88f3-dde34467e31b 34 fields · synced May 30, 2026
- EUDAMED 80db57e2-e852-496d-b046-9858a2aec0b4 61 fields · synced Jul 17, 2026