Identity
- Trade Name
- GYROSCAN(TM) FDA PMA
- Generic Name
- System, nuclear magnetic resonance imaging FDA PMA
Identifiers
- PMA Number
- P840063 FDA PMA
- FDA Product Code
- LNH FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 892.1000 FDA PMA
- Regulation Number
- 892.1000 FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S006 (Normal 180 Day Track) FDA PMA
The GyroScan System is a Nuclear Magnetic Resonance Imaging (NMRI) device, designed for diagnostic imaging of the human body using strong magnetic fields and radio waves. It generates detailed images of internal structures, including soft tissues, organs, and skeletal systems, to aid in the diagnosis and monitoring of medical conditions.
This system is intended for use in radiology departments within clinical settings and is supplied as a reusable medical device. It operates in environments compatible with MRI safety standards and is regulated under FDA Premarket Approval (PMA). The device requires proper installation, calibration, and maintenance by trained personnel to ensure accurate imaging and patient safety.
Frequently asked questions
What is the primary purpose of the GyroScan™ system in a clinical setting and how does it function?
The GyroScan™ system is a Nuclear Magnetic Resonance Imaging (NMRI) device designed to generate detailed images of internal human structures, including soft tissues, organs, and bones. It uses strong magnetic fields and radio waves to create these images, aiding in the diagnosis and monitoring of medical conditions such as tumors, joint issues, or cardiovascular problems. This technology is particularly useful for radiology departments where precise, non-invasive imaging is required.
Is the GyroScan™ system reusable, and what maintenance does it require?
Yes, the GyroScan™ system is supplied as a reusable medical device. Due to its complexity and the need to maintain MRI safety standards, it requires proper installation, calibration, and regular maintenance by trained personnel. This ensures accurate imaging performance and patient safety, as the device operates in environments with strict electromagnetic compatibility requirements.
What regulatory pathway was followed for the approval of the GyroScan™ system, and what does this mean for its use?
The GyroScan™ system was approved through the FDA Premarket Approval (PMA) process, as indicated by the PMA number (P840063). This means the device underwent rigorous review to demonstrate its safety and effectiveness before being authorized for use in clinical settings. Clinicians and facilities can rely on this approval to ensure the device meets regulatory standards for diagnostic imaging.
How many distinct models or configurations of the GyroScan™ system have been registered, and what does this imply for compatibility?
The GyroScan™ system includes multiple registration numbers (e.g., 3023003446, 3031503890, etc.), suggesting it may encompass various models or configurations within the broader system category. These variations likely cater to different clinical needs or upgrades over time. Compatibility should be verified with Philips Medical Systems, Inc., as each model may have specific technical requirements or software updates to ensure seamless integration into existing radiology workflows.
What safety considerations should be taken into account when operating the GyroScan™ system in a clinical environment?
The GyroScan™ system operates under MRI safety standards, which means it requires careful handling to prevent hazards like magnetic field interference or projectiles. Clinicians and staff must follow strict protocols for patient screening (e.g., removing metallic objects), equipment maintenance, and emergency procedures. The device’s reusable nature also necessitates adherence to manufacturer guidelines for cleaning, calibration, and servicing to uphold safety and imaging accuracy.
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 (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P840063 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA PMA P840063 23 fields · synced Sep 18, 2026