Shoulder Array Coils Models HRS-63-8 and HRS-127-8
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K053017 FDA 510(k)
- FDA Product Code
- MOS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Shoulder Array Coils Models HRS-63-8 and HRS-127-8 are specialty magnetic resonance coils designed as radiofrequency (RF) receivers. They are intended to capture MR signals from the shoulder anatomy, enhancing image quality for diagnostic imaging in radiology settings. These coils are classified as Class II devices under the FDA’s specialty coil category and function in conjunction with MR scanners to improve signal detection and resolution.
These coils are supplied as reusable medical devices and are intended for use in MRI-compatible environments. They are not sterile and require proper cleaning and maintenance between uses. The devices are regulated under FDA’s 510(k) clearance (K053017) and are intended for clinical use by trained medical personnel in radiology departments. Compliance with manufacturer instructions for MRI safety, storage, and handling is essential to ensure proper functionality and patient safety.
Frequently asked questions
What are the Invivo HRS-63-8 and HRS-127-8 Shoulder Array Coils used for?
These coils are specialty magnetic resonance (MR) radiofrequency (RF) receiver coils designed specifically to capture MR signals from the shoulder anatomy. By improving signal detection and resolution, they enhance the quality of diagnostic imaging in radiology settings, aiding clinicians in accurate shoulder assessments.
Are the HRS-63-8 and HRS-127-8 coils single-use or reusable?
The HRS-63-8 and HRS-127-8 Shoulder Array Coils are reusable medical devices. Proper cleaning and maintenance between uses are required to ensure functionality and patient safety, as outlined in the manufacturer’s instructions.
Do these coils come sterile, and what are the handling requirements?
The coils are not sterile and must be cleaned and maintained according to the manufacturer’s guidelines before each use. Since they are reusable, adherence to MRI safety protocols and proper disinfection procedures is essential to prevent contamination and ensure reliable performance.
What storage conditions are recommended for these shoulder array coils?
The coils should be stored in a clean, dry environment, protected from physical damage and electromagnetic interference. They must be kept in an MRI-compatible setting, following the manufacturer’s instructions for storage to maintain functionality and integrity for repeated use.
What regulatory clearance do these coils hold, and who should use them?
The HRS-63-8 and HRS-127-8 Shoulder Array Coils are cleared under the FDA’s 510(k) pathway (K053017) as Class II specialty MR coils. They are intended for use by trained medical personnel in radiology departments, ensuring proper handling and compliance with MRI safety standards.
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: PDF K053017 - Models Hrs-63-8 and Hrs-127-8 Shoulder Array Coils, Models Hrs-63-8 And Hrs-127-8 Shoulder Array Coils 510 (k) FDA ..., fda.innolitics.com, Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053017 | Class II | Active |
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Manufacturer
- Manufacturer
- Invivo Corporation
Sources (1)
- FDA 510(k) K053017 24 fields · synced Oct 1, 2026