(29 days)
The UroVantage is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to Urologic and endoscopic procedures. The device may be used for other imaging applications at physician's discretion.
The UroVantage is an Image-Intensified Fluoroscopic X-Ray System and radiological table. The device consists of: a tilting patient support table; x-ray generator; control panel; remote control panel, x-ray tube assembly, collimator, image intensifier, television ("TV") system with monitor; tableside control. The Isocentric C-arm of the UroVantage ensures easy control and issues intensifier and x-ray tube around the patient. The device s movement of x-ray stand with a tilting table also provides support for both the thou modition is as a m. Standard and optional accessories also are supplied.
The UroVantage is a modification to PCK's UROlogic device that has already been The Orovide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures (K011311). The during diagnootic, barger intended use and fundamental scientific technology as the Orovantage nas the battle interations are: (1) replacement of the fixed imaging arm ("U" arm) with an Isocentric C-Arm; (2) the fixation of the Isocentric C-arm to the support table; (3) minor changes in the dimensions of the support table; and (4) changes in the software to accommodate the use of the Isocentric C-arm.
This 510(k) summary for the UroVantage Urological Table does not contain information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.
The document focuses on demonstrating substantial equivalence to a predicate device (UROlogic, K011311) based on:
- Same intended use and indications for use.
- Similar technological characteristics and principles of operation.
- Minor differences that do not raise new questions of safety or efficacy.
Therefore, I cannot provide the requested information. The submission describes a device modification, relying on the predicate's established safety and effectiveness rather than presenting new performance data for the UroVantage itself.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.