Identifiers
- 510(k) Number
- K211846 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 Discovery MI Gen2 is a Positron Emission Tomography/Computed Tomography (PET/CT) system designed for producing attenuation-corrected PET images. It integrates both PET and CT imaging modalities to enable simultaneous visualization of metabolic and anatomical structures, facilitating comprehensive diagnostic assessment.
This device is intended for use in clinical settings by qualified healthcare professionals, supplying whole-body imaging for radiopharmaceutical distribution and localization. It is supplied as a reusable system, with regulatory authorizations including FDA 510(k) clearance and MDR compliance. The system supports imaging of multiple anatomical regions, including the brain, heart, lungs, and gastrointestinal system, and is intended for radiotherapy planning, therapy guidance, and interventional radiology procedures.
Frequently asked questions
What clinical applications does the Discovery MI Gen2 support beyond standard PET/CT imaging?
The Discovery MI Gen2 is designed to support comprehensive diagnostic assessments by combining PET and CT imaging. Beyond standard attenuation-corrected PET imaging, it aids in radiotherapy planning, therapy guidance, and interventional radiology procedures. This dual-modality approach allows simultaneous visualization of metabolic activity (via PET) and anatomical structures (via CT), which is particularly useful for evaluating regions like the brain, heart, lungs, and gastrointestinal system.
Is the Discovery MI Gen2 intended for single-use or reusable applications in clinical settings?
The Discovery MI Gen2 is explicitly described as a reusable system, meaning it is designed for repeated use in clinical settings after proper maintenance and sterilization procedures. This aligns with its regulatory authorizations, including FDA 510(k) clearance and MDR compliance, which account for its durable, multi-patient use.
How does the Discovery MI Gen2 differ from other PET/CT systems in terms of regulatory approval?
The Discovery MI Gen2 holds FDA 510(k) clearance and MDR compliance, indicating it has been evaluated as substantially equivalent to predicate devices under the U.S. regulatory framework. The system was reviewed by the Radiology (RA) Advisory Committee and falls under product code KPS, which categorizes it as a Class II medical device for diagnostic imaging. This regulatory route ensures it meets stringent standards for safety and performance in clinical radiology applications.
What anatomical regions can the Discovery MI Gen2 effectively image, and why is this important?
The Discovery MI Gen2 is capable of imaging multiple key anatomical regions, including the brain, heart, lungs, and gastrointestinal system. This versatility is critical for comprehensive diagnostic assessments, as it enables clinicians to correlate metabolic activity (from PET) with precise anatomical details (from CT), improving accuracy in conditions like oncology, cardiology, and neurology. The system’s ability to cover these regions supports tailored treatment planning and monitoring.
What does the inclusion of multiple FEI numbers (e.g., 3015232217) in the specifications indicate about the Discovery MI Gen2?
The extensive list of FEI (Facility Equipment Identifier) numbers reflects the system’s modular or configurable nature, allowing hospitals to customize components like detectors, gantries, or software upgrades while maintaining compliance with regulatory tracking. These identifiers ensure traceability for maintenance, recalls, or updates, which is essential for a reusable medical device like the Discovery MI Gen2. Each FEI corresponds to specific parts or configurations that may vary by facility setup.
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, LLC. - Food and Drug Administration, K211846 FDA 510(k) - Discovery MI Gen2 | Ge Medical Systems, LLC, Discovery MI Gen2 (K211846) — FDA 510 (k) | Innolitics
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 | K211846 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
Sources (2)
- FDA 510(k) K211846 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026