TRILLIUM Oval Head Coil 32
by Hitachi Medical Systems America, Inc.
510(k) K162079
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162079 | Date16 Sep 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MOS
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Trillium Oval Head Coil 32 is a Magnetic Resonance, Specialty Coil designed as a 32-channel, receive-only, rigid multiple-array coil. It functions exclusively as an RF receiver to capture MR signals from hydrogen nuclei in the head region during MRI procedures, enhancing signal detection for imaging.
This coil is intended for use with Hitachi TRILLIUM Oval 3.0 Tesla MRI systems and is classified as a Class II device under FDA regulations (Regulation Number 892.1000). Supplied as a reusable, non-sterile component, it requires proper handling and storage in accordance with MRI system manufacturer guidelines. The device holds FDA 510(k) clearance (K162079) and is regulated under the Radiology medical specialty.
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Questions
AI-generated answers, 1 Oct 2026
What is the Trillium Oval Head Coil 32 used for?
The Trillium Oval Head Coil 32 is designed exclusively as a receive-only RF coil for Magnetic Resonance Imaging (MRI). It captures MR signals from hydrogen nuclei in the head region, significantly improving signal detection and enhancing image quality during MRI procedures. This coil is specifically engineered for use with Hitachi TRILLIUM Oval 3.0 Tesla MRI systems.
Is the Trillium Oval Head Coil 32 reusable or single-use?
The Trillium Oval Head Coil 32 is supplied as a reusable component. It is not intended for single-use and must be handled and stored according to the manufacturer’s guidelines to ensure proper functionality and longevity. Reusability is common for high-end MRI coils to maintain cost-effectiveness and performance consistency.
What are the key specifications of the Trillium Oval Head Coil 32?
The Trillium Oval Head Coil 32 is a 32-channel, rigid multiple-array coil designed for receive-only functionality. It is intended for use exclusively with Hitachi TRILLIUM Oval 3.0 Tesla MRI systems. The coil is classified as a Class II device under FDA regulations and holds FDA 510(k) clearance (K162079). It is not sterile and requires proper cleaning and storage to maintain performance.
How should the Trillium Oval Head Coil 32 be stored?
The Trillium Oval Head Coil 32 must be stored in accordance with the manufacturer’s guidelines provided by Hitachi Medical Systems. Since it is a reusable, non-sterile component, it should be kept in a clean, dry environment, protected from physical damage, and stored away from sources of electromagnetic interference. Follow the specific instructions included with the device to ensure optimal performance and longevity.
What systems is the Trillium Oval Head Coil 32 compatible with?
The Trillium Oval Head Coil 32 is designed for exclusive use with Hitachi TRILLIUM Oval 3.0 Tesla MRI systems. Compatibility is limited to these specific systems to ensure optimal signal detection and imaging performance. Always verify system compatibility with the manufacturer’s documentation before use.