Fluoropro RF Digital Imaging System
510(k) K070390
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070390 | Date5 Apr 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JAA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Fluoropro RF Digital Imaging System is an X-Ray, Fluoroscopic, Image-Intensified System (per FDA nomenclature). It combines fluoroscopic imaging with digital processing to capture real-time radiographic images, enabling enhanced visualization for diagnostic and interventional procedures in radiology.
This system is designed for use in radiology departments, where it integrates a fluoroscopic TV camera, monitors, and an image processor to facilitate hardcopy printing via laser or network-based storage. It is a Class II medical device, cleared under FDA 510(k) K070390 with a Substantially Equivalent determination, and is intended for reusable clinical settings. No MRI safety or sterility specifications are noted in the regulatory data.
Other devices from Virtual Imaging, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of procedures is the Fluoropro RF Digital Imaging System designed to support in a clinical setting?
The Fluoropro RF Digital Imaging System is specifically designed for radiology departments to support diagnostic and interventional procedures requiring real-time radiographic imaging. It combines fluoroscopy with digital processing to enhance visualization during procedures like fluoroscopy-guided interventions, angiography, or other radiology exams where continuous X-ray imaging is necessary.
How is the Fluoropro RF Digital Imaging System intended to be used in terms of reuse and maintenance?
The Fluoropro RF Digital Imaging System is intended for reusable clinical settings, meaning it is engineered for repeated use in a hospital or radiology department after proper cleaning and maintenance. Since it is not described as sterile or MRI-safe, it must be handled according to standard infection control protocols for reusable medical imaging equipment.
What output options are available for capturing and storing images from the Fluoropro RF Digital Imaging System?
The system integrates a fluoroscopic TV camera and image processor to provide real-time imaging, with the ability to generate hardcopy prints via laser printing or store images network-based. This allows for flexibility in how radiology staff review and archive diagnostic images.
Are there different models or configurations available for the Fluoropro RF Digital Imaging System?
The provided data lists multiple registration numbers (e.g., 3013099020, 3005706667) under the Fluoropro RF Digital Imaging System, which may indicate variations in models or configurations. However, the exact differences between these models are not specified in the regulatory data, so you would need to consult Virtual Imaging, Inc. for detailed specifications on available configurations.
How should the Fluoropro RF Digital Imaging System be stored when not in use?
Since the system is reusable and not described as sterile, it should be stored in a clean, dry environment protected from dust, moisture, and physical damage. The manufacturer’s guidelines (not provided here) should be followed for proper disconnection of components, cleaning, and storage to ensure optimal performance and longevity.