Insight FD Mini C-Arm Fluoroscopic Imaging System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120388 FDA 510(k)
- FDA Product Code
- OXO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Insight FD Mini C-Arm Fluoroscopic Imaging System is a mobile, image-intensified fluoroscopic X-ray device designed for real-time radiographic visualization. It provides high-resolution imaging of skeletal structures, particularly extremities, to support diagnostic and interventional procedures in clinical and surgical environments. This compact system incorporates an image-intensifier tube to enhance fluoroscopic performance, enabling precise guidance during orthopedic, podiatric, and emergency interventions.
This system is supplied as a reusable medical device, intended for use in radiology settings where portability and flexibility are required. It is not classified as MRI-safe but is designed for use in standard radiographic environments. The device is regulated under FDA 510(k) clearance (K120388) and falls under the classification of Class II medical devices (21 CFR 892.1650). Storage and handling follow standard protocols for radiographic equipment, ensuring proper calibration and maintenance to sustain imaging accuracy and safety.
Frequently asked questions
What is the Insight FD Mini C-Arm Fluoroscopic Imaging System used for?
The Insight FD Mini C-Arm Fluoroscopic Imaging System is designed for real-time radiographic visualization of skeletal structures, particularly extremities. It supports diagnostic and interventional procedures in clinical and surgical environments, such as orthopedic and podiatric interventions, by providing high-resolution imaging. The compact, mobile design ensures flexibility in settings where portability is essential.
Is the Insight FD Mini C-Arm Fluoroscopic Imaging System reusable or single-use?
This device is supplied as a reusable medical device. It is intended for use in radiology settings where portability and repeated use are required, provided it undergoes proper calibration and maintenance to ensure imaging accuracy and safety. Reusability is managed through adherence to standard radiographic equipment protocols.
What safety considerations should be noted when using the Insight FD Mini C-Arm?
The Insight FD Mini C-Arm is not classified as MRI-safe, so it should not be used in MRI environments. It is designed for standard radiographic environments where X-ray safety protocols are followed. Proper storage, handling, and maintenance are critical to sustaining imaging performance and ensuring patient safety during procedures.
How is the device regulated and approved?
The Insight FD Mini C-Arm Fluoroscopic Imaging System is regulated under FDA 510(k) clearance with the clearance number K120388. It is classified as a Class II medical device under 21 CFR 892.1650, indicating it has undergone a review by the FDA to demonstrate substantial equivalence to a predicate device. This classification ensures it meets established safety and effectiveness standards.
What types of procedures benefit most from this fluoroscopic imaging system?
This system is particularly beneficial for procedures requiring precise visualization of skeletal structures, such as orthopedic surgeries (e.g., fracture fixation, joint replacements), podiatric interventions (e.g., foot and ankle procedures), and emergency interventions where real-time imaging guidance is critical. The compact and mobile nature of the device allows for use in various clinical settings, including operating rooms and trauma bays.
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: Insight | Insight Enterprises, Fluoroscan® Insight Mini C-Arm | Extremity Imaging | Hologic, PDF Extremity Imaging Fluoroscan InSight FD Mini C-Arm Imaging System - Hologic, PDF InSight FD Mini C-arm User Guide - manuallib.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120388 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA 510(k) K120388 24 fields · synced Oct 1, 2026