Airis-Elite Rapid Body Coil, Model 554HI-12
510(k) K033292
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033292 | Date26 Nov 2003 | 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- Withdrawn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 Airis-Elite Rapid Body Coil, Model 554HI-12, is a Magnetic Resonance, Specialty Coil designed as an RF receiver coil for use with Hitachi AIRIS-Elite 0.3T MRI systems. It captures magnetic resonance signals from patient anatomy in the chest-to-pelvic region, enabling high-resolution imaging for diagnostic purposes. Compatible with parallel imaging techniques, it supports advanced MRI modalities such as 2D/3D proton density, T1/T2-weighted, time-of-flight, and phase contrast imaging.
This coil is supplied as a reusable accessory for MRI systems and is intended for clinical use in radiology settings. It is not sterile and requires proper handling and storage to maintain functionality. The device has received FDA 510K clearance under the classification of Class II medical devices (regulation number 892.1000) and is registered under the product code MOS. Compatibility with the Hitachi AIRIS-Elite system ensures integration with existing MRI workflows for diagnostic imaging.
Other devices from Medical Advances, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Airis-Elite Rapid Body Coil, Model 554HI-12 used for?
The Airis-Elite Rapid Body Coil, Model 554HI-12, is an RF receiver coil designed specifically for Magnetic Resonance Imaging (MRI) systems. It captures magnetic resonance signals from the chest-to-pelvic region of the patient, enabling high-resolution imaging. This coil supports advanced MRI modalities such as 2D/3D proton density, T1/T2-weighted, time-of-flight, and phase contrast imaging, making it ideal for detailed diagnostic evaluations in radiology settings.
How is the Airis-Elite Rapid Body Coil, Model 554HI-12 supplied and intended for use?
The coil is supplied as a reusable accessory for Hitachi AIRIS-Elite 0.3T MRI systems. It is intended for clinical use in radiology departments where high-quality imaging of the torso is required. Since it is reusable, proper handling and storage protocols must be followed to maintain its functionality and ensure patient safety.
Is the Airis-Elite Rapid Body Coil, Model 554HI-12 sterile?
No, the Airis-Elite Rapid Body Coil, Model 554HI-12, is not sterile. It is designed for reusable clinical applications and must be cleaned and maintained according to the manufacturer’s guidelines to prevent contamination and ensure reliable performance during MRI scans.
What MRI systems is the Airis-Elite Rapid Body Coil, Model 554HI-12 compatible with?
The coil is exclusively compatible with Hitachi AIRIS-Elite 0.3T MRI systems. Its design ensures seamless integration with these systems, enabling radiologists to leverage advanced imaging techniques like parallel imaging for improved diagnostic accuracy.
How should the Airis-Elite Rapid Body Coil, Model 554HI-12 be stored?
The coil should be stored in a clean, dry environment, protected from physical damage and exposure to moisture or extreme temperatures. Since it is reusable, it must be cleaned thoroughly after each use following the manufacturer’s instructions to maintain its performance and longevity. Proper storage also helps prevent contamination and ensures compatibility with the MRI system.