Universal Digital Interface UDI 1717
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K112527 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 Universal Digital Interface UDI 1717 is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed to enable digital communication between ablation equipment and imaging systems. It integrates real-time imaging data to enhance procedural precision, particularly in radiology applications requiring accurate tumor targeting during minimally invasive interventions.
This device is supplied as a reusable Class 2 medical instrument, regulated under FDA 510(k) clearance (K112527) and product code MQB. It is intended for use in radiology settings, adhering to MRI safety standards for its designated applications. Storage and handling follow manufacturer guidelines to maintain performance and sterility where applicable.
Frequently asked questions
What is the primary purpose of the Universal Digital Interface (UDI) 1717 in clinical settings?
The UDI 1717 is designed to serve as a Solid State X-Ray Imager (Flat Panel/Digital Imager) that facilitates real-time digital communication between ablation equipment and imaging systems. Its main role is to enhance procedural precision in radiology applications, particularly for accurate tumor targeting during minimally invasive interventions, by integrating imaging data seamlessly.
Is the UDI 1717 intended for single-use or reusable applications, and how should it be handled?
The UDI 1717 is reusable and classified as a Class 2 medical instrument. Proper storage and handling must follow the manufacturer’s guidelines to maintain performance and ensure longevity. Since it is not sterile out-of-box, cleaning and reprocessing protocols (if applicable) should align with established medical device decontamination standards for reusable radiology equipment.
Does the UDI 1717 require any special considerations for use in MRI environments?
Yes, the UDI 1717 is designed to adhere to MRI safety standards for its designated applications. This means it has been evaluated to ensure compatibility with MRI environments, reducing risks like interference or safety hazards during procedures. Always verify the manufacturer’s instructions for specific MRI-compatible configurations and limitations.
How is the UDI 1717 regulated, and what does that mean for purchasing or using it?
The UDI 1717 is regulated under the FDA 510(k) clearance pathway, with clearance number K112527 and product code MQB. This means it has been deemed substantially equivalent to a legally marketed predicate device and is classified as Class 2, indicating moderate regulatory oversight. Purchasers should confirm compliance with FDA requirements and ensure the device meets their facility’s clinical and procedural needs before integration.
Are there different models or sizes available for the UDI 1717, or is it a single standardized unit?
The provided data does not specify distinct models or sizes for the UDI 1717, but it references multiple FEI numbers (e.g., 3009717300, 3015223550), which may correspond to variations in configurations, firmware versions, or compatibility settings. For exact specifications, consult the manufacturer’s documentation or contact Meridian Medical Systems, LLC at 325 Harris Dr., Aurora, OH 44202 for clarification on available variants.
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: Universal Digital Interface UDI 1717 - Meridian Medical Systems | FDA ..., Universal Digital Interface UDI 1717 - Meridian Medical Systems | FDA ..., UNIVERSAL DIGITAL INTERFACE (UDI) 1717 - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112527 | Class II | Active |
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Manufacturer
- Manufacturer
- Meridian Medical Systems, LLC
Sources (1)
- FDA 510(k) K112527 24 fields · synced Sep 19, 2026