Signa Voyager, Signa Voyager Quantum
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192426 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 Signa Voyager and Signa Voyager Quantum are System, Nuclear Magnetic Resonance Imaging devices, designed for high-field magnetic resonance imaging (MRI) of the human body. These systems generate detailed images of internal structures using strong magnetic fields and radiofrequency waves, enabling diagnostic evaluation of soft tissues, organs, and skeletal systems. They are classified under Device Class II and are intended for radiology applications, including but not limited to, musculoskeletal, cardiovascular, and neurological assessments. The devices incorporate advanced imaging technologies to enhance contrast resolution and spatial accuracy for clinical decision-making.
These MRI systems are reusable and intended for use in sterile or semi-sterile environments, such as hospital radiology departments or specialized imaging centers. They are MRI-safe and comply with FDA 510(k) clearance (K192426) and MDR (Medical Device Regulation) requirements. The systems are supplied with multiple FEI numbers (e.g., 3008156140, 3021593788) corresponding to specific configurations or software versions, ensuring traceability and regulatory alignment. Storage and handling follow manufacturer guidelines to maintain performance and safety, including proper calibration and environmental controls.
Frequently asked questions
Are the Signa Voyager and Signa Voyager Quantum MRI systems designed for single-use or can they be reused in a clinical setting?
The Signa Voyager and Signa Voyager Quantum MRI systems are not single-use—they are reusable devices intended for use in sterile or semi-sterile environments like hospital radiology departments. Their design allows for repeated use under proper maintenance, calibration, and cleaning protocols as outlined by the manufacturer.
What types of clinical assessments are these MRI systems primarily used for, and how do they enhance diagnostic accuracy?
These systems are designed for high-field magnetic resonance imaging (MRI) of the human body, enabling detailed visualization of soft tissues, organs, and skeletal systems. They are particularly suited for radiology applications such as musculoskeletal, cardiovascular, and neurological assessments. Advanced imaging technologies improve contrast resolution and spatial accuracy, aiding clinicians in making more precise diagnostic evaluations.
How are the Signa Voyager and Signa Voyager Quantum MRI systems regulated, and what does this mean for buyers or healthcare providers?
The devices hold FDA 510(k) clearance (K192426) and comply with MDR (Medical Device Regulation) requirements, confirming they meet regulatory standards for safety and performance. This classification under Device Class II and the Radiology advisory committee (RA) designation ensures they undergo rigorous review for their intended use in diagnostic imaging. Buyers can rely on this regulatory alignment for confidence in their clinical application.
What storage and handling guidelines should be followed to maintain the performance and safety of these MRI systems?
The manufacturer provides specific storage and handling guidelines to preserve performance and safety, including proper calibration, environmental controls, and maintenance protocols. These systems are designed for use in controlled environments like radiology departments, where adherence to these instructions ensures optimal functionality and compliance with regulatory requirements.
How do the multiple FEI numbers (e.g., 3008156140) associated with these MRI systems relate to their regulatory and operational use?
The listed FEI numbers correspond to specific configurations or software versions of the Signa Voyager and Signa Voyager Quantum systems, ensuring traceability and alignment with regulatory submissions. These identifiers help track compliance, software updates, and system-specific requirements, which is critical for maintaining regulatory approvals and operational consistency in clinical settings.
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: Signa Voyager, Signa Voyager Quantum 510 (k) K192426 - FDA.report, Signa Voyager, Signa Voyager Quantum (K192426) — FDA 510 (k) | Innolitics, SIGNA
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192426 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare Tianjin Company Limited
- FDA Applicant
- Ge Healthcare (Tianjin) Company Limited
Sources (2)
- FDA 510(k) K192426 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026