Prudent 1717, Prudent 1417, Prudent 1212
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211108 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Prudent 1717, Prudent 1417, and Prudent 1212 are solid-state X-ray imagers classified as flat panel or digital imagers. These devices convert X-ray exposure into digital signals for radiologic imaging, enabling high-resolution visualization of internal structures for diagnostic purposes in radiology.
These imagers are designed for use in radiology settings and are supplied as reusable devices. They are classified under FDA device class II and comply with the Medical Device Regulation (MDR) in the EU. The models are authorized through FDA 510(k) clearance and are intended for integration into X-ray imaging systems for various diagnostic applications, adhering to MRI safety standards where applicable.
Frequently asked questions
Are the Prudent 1717, Prudent 1417, and Prudent 1212 imagers designed for single-use or can they be reused in a clinical setting?
The Prudent 1717, Prudent 1417, and Prudent 1212 are explicitly described as reusable devices. They are intended for integration into X-ray imaging systems in radiology settings, meaning they are built to withstand repeated use while maintaining performance for diagnostic imaging.
What regulatory pathways have these devices undergone, and where are they authorized for use?
The Prudent 1717, Prudent 1417, and Prudent 1212 have been authorized through FDA 510(k) clearance (traditional pathway, classified as Class II) and comply with the EU Medical Device Regulation (MDR). This means they meet U.S. and European regulatory standards for solid-state X-ray imagers used in radiology.
How do I determine which model (1717, 1417, or 1212) is best suited for my imaging system?
The device data does not specify technical differences between the models (such as resolution, size, or field of view) beyond their classification as solid-state X-ray imagers. To select the appropriate model, you would need to consult PixxGen Corporation’s technical documentation or contact their support team, as the choice depends on your specific imaging system requirements and compatibility.
Are these devices compatible with MRI environments, and if so, how should they be handled?
The Prudent imagers are designed with MRI safety standards in mind, meaning they are intended for use in environments where MRI equipment is present. However, proper handling and placement are critical to avoid interference or safety risks. Always follow the manufacturer’s guidelines for positioning and use in mixed radiology/MRI settings.
What should I consider when storing these reusable X-ray imagers to maintain their performance?
While the data does not specify storage conditions, reusable medical devices like these typically require clean, dry environments to prevent contamination or damage. Ensure they are stored in a way that protects them from physical stress, moisture, or electromagnetic interference. Always refer to PixxGen Corporation’s instructions for proper storage and maintenance to preserve functionality and sterility (if applicable).
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 (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 | K211108 | Class II | Active |
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Manufacturer
- Manufacturer
- PixxGen Corporation
Sources (2)
- FDA 510(k) K211108 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026