Identifiers
- 510(k) Number
- K921891 FDA 510(k)
- FDA Product Code
- LNH 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 Silent Scan MRI Audio System is a System, Nuclear Magnetic Resonance Imaging device designed to facilitate patient communication and audio monitoring within MRI environments. It mitigates interference from MRI electromagnetic fields, ensuring clear audio transmission for diagnostic and procedural purposes.
This system is intended for use in MRI facilities, providing MRI-compatible audio solutions with headset options for patient communication and monitoring. Supplied as a reusable device, it adheres to MRI safety standards and is regulated under FDA 510K clearance (K921891). Authorized for Class II medical devices under regulation number 892.1000, it requires proper handling and storage to maintain functionality.
Frequently asked questions
What is the Silent Scan MRI Audio System primarily designed to address in an MRI environment?
The Silent Scan MRI Audio System is specifically designed to facilitate clear patient communication and audio monitoring within MRI facilities. It mitigates interference from MRI electromagnetic fields, ensuring reliable audio transmission for both diagnostic and procedural purposes, which is critical for maintaining patient safety and effective clinical workflows.
Is the Silent Scan MRI Audio System reusable or single-use, and how does this affect its maintenance?
The Silent Scan MRI Audio System is supplied as a reusable device. Since it is not single-use, proper cleaning, disinfection, and maintenance protocols must be followed to ensure functionality, safety, and compliance with MRI safety standards over repeated use.
What types of headset options are included with the Silent Scan MRI Audio System, and how do they contribute to its functionality?
The Silent Scan MRI Audio System includes MRI-compatible headset options, which are essential for patient communication and monitoring. These headsets are designed to operate reliably within MRI environments without interference from electromagnetic fields, ensuring clear audio transmission for both patients and clinicians.
How should the Silent Scan MRI Audio System be stored to maintain its functionality and safety?
The Silent Scan MRI Audio System requires proper handling and storage to maintain its functionality and safety. Since it is a reusable device, it should be stored in a clean, dry environment, away from sources of electromagnetic interference, and according to manufacturer guidelines to preserve its MRI-compatible performance and longevity.
What regulatory pathway was followed for the Silent Scan MRI Audio System, and what does this mean for its use?
The Silent Scan MRI Audio System was cleared through the FDA’s 510(k) process, specifically under the Traditional pathway with a decision code of SESE (Substantially Equivalent) and assigned the classification of Class II medical device under regulation number 892.1000. This means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and performance standards for use in MRI environments.
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: Avotec MRI Audio Systems | Silent Scan®, All Products - Avotec, Avotec Silent Scan® | Psychology Software Tools - pstnet.com, Avotec Silent Scan - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K921891 | Class II | Active |
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Manufacturer
- Manufacturer
- Avotec, Inc.
Sources (1)
- FDA 510(k) K921891 24 fields · synced Sep 19, 2026