Identifiers
- 510(k) Number
- K241665 FDA 510(k)
- FDA Product Code
- KPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1200 FDA 510(k)
- Regulation Number
- 892.1200 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Omni Legend is a computed emission tomography (PET/CT) system designed for hybrid functional and anatomical imaging. It generates attenuation-corrected PET images to support clinical assessments in oncology, cardiology, and neurology by integrating metabolic and structural data.
This device is supplied as a reusable medical system intended for use in radiology departments. It requires regulatory compliance with FDA 510(k) clearance (K241665) and MDR authorisation, with no third-party involvement. The system operates within Class II (radiological health) and is not classified as MRI-safe or unsafe. Storage and handling follow standard institutional protocols for imaging equipment.
Frequently asked questions
What clinical specialties does the Omni Legend PET/CT system primarily support, and how does it integrate metabolic and anatomical data?
The Omni Legend is designed for hybrid imaging in oncology, cardiology, and neurology. It combines PET (positron emission tomography) and CT (computed tomography) to generate attenuation-corrected PET images, enabling clinicians to assess both metabolic activity and anatomical structure simultaneously. This integration helps in precise diagnosis, treatment planning, and monitoring of diseases in these specialties.
Is the Omni Legend system reusable, and what are the standard storage and handling requirements?
Yes, the Omni Legend is supplied as a reusable medical system intended for use in radiology departments. Storage and handling follow standard institutional protocols for imaging equipment, as it is not a single-use device. Proper maintenance and compliance with manufacturer guidelines are essential to ensure optimal performance and safety.
What regulatory pathways has the Omni Legend undergone, and how does this affect its use in clinical settings?
The Omni Legend has obtained FDA 510(k) clearance (K241665) and MDR authorization, demonstrating compliance with both U.S. and European regulatory standards. This clearance confirms that the device meets the necessary safety and performance requirements for use in clinical settings, ensuring its reliability for hybrid PET/CT imaging in radiology departments.
Does the Omni Legend have any specific safety considerations related to MRI environments?
The Omni Legend is explicitly not classified as MRI-safe or MRI-unsafe. This means it should not be used in MRI environments, and users must follow strict protocols to avoid interference or risks associated with magnetic fields. Always consult institutional guidelines for proper handling and placement.
How can I verify the regulatory status or compliance of the Omni Legend before purchasing or implementing it?
The Omni Legend holds FDA 510(k) clearance (K241665) and MDR authorization, which are publicly documented in regulatory databases. You can verify its compliance by checking the FDA’s OpenFDA portal or the manufacturer’s official documentation. Additionally, the device’s product code (KPS) and registration numbers confirm its classification under Class II (radiological health) and adherence to relevant 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 GE Medical Systems Israel, Functional Imaging August 8th Alexandra ..., GE Medical Systems Israel, Functional Imaging: Omni Legend (FDA-cleared ..., General Electric Medical Systems Israel, Functional Imaging
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 | K241665 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems Israel, Functional Imaging
Sources (2)
- FDA 510(k) K241665 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026