Interventional Fluoroscopic X-Ray System Urologic

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Urologic

510(k) Number

K011311 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Lithodiamond Ultra

  Class II

  FDA 510(k) K061350 Active Cleared 22 Dec 2006

• Stonelith Model V5

  Class II

  FDA 510(k) K011106 Active Cleared 11 Feb 2002

• Urovantage

  Class II

  FDA 510(k) K053279 Active Cleared 22 Dec 2005

• What is the Urologic Fluoroscopic X-Ray System used for?

  The Urologic Fluoroscopic X-Ray System is designed for real-time radiographic imaging during urological procedures. This includes guiding interventions such as catheter placements, stone removal (e.g., lithotripsy), and biopsies within the urinary tract. The continuous X-ray visualization enhances precision, reduces procedural risks, and improves clinical outcomes by providing immediate feedback during complex interventions.

• Is the Urologic Fluoroscopic X-Ray System reusable or single-use?

  This system is supplied as a reusable device. As a Class II medical device, it requires adherence to strict maintenance and sterilization protocols outlined by the manufacturer to ensure safety, functionality, and compliance with regulatory standards. Proper cleaning and sterilization between uses are essential to prevent cross-contamination and maintain performance.

• What models or references are included in the Urologic Fluoroscopic X-Ray System?

  The Urologic Fluoroscopic X-Ray System encompasses multiple model references, each corresponding to specific configurations or variations of the device. These include FEI numbers such as 3002619595, 3005706667, 3015232217, and others listed in the FDA submission records. The exact model determines technical specifications like image resolution, fluoroscopy capabilities, and compatibility with accessories, so verifying the correct reference is critical for procurement and use.

• How should the Urologic Fluoroscopic X-Ray System be stored?

  Storage of the Urologic Fluoroscopic X-Ray System must follow manufacturer guidelines to preserve functionality and ensure safety. Since it is reusable, storage areas should be clean, dry, and protected from physical damage or environmental contaminants. Components like the X-ray tube, detector, and control panels may require specific conditions (e.g., temperature control, shielding from electromagnetic interference) to maintain calibration and performance. Always refer to the manufacturer’s instructions for detailed storage protocols.

• What regulatory pathway does the Urologic Fluoroscopic X-Ray System follow?

  The Urologic Fluoroscopic X-Ray System is authorized under the FDA 510(k) clearance pathway, specifically with clearance number K011311. This classification confirms that the device is substantially equivalent to a legally marketed predicate device and adheres to FDA regulations for interventional fluoroscopic imaging equipment. The system is categorized under Class II, indicating moderate regulatory oversight, and must comply with additional standards such as MRI safety considerations where applicable.