UroPro 2000 Tomographic Option

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

Full name

Medstone, Uropro 2000, Tomographic Option

510(k) Number

K013620 ↗

FDA Product Code

IZF

Device Class

Class II

Regulation

21 CFR Part 892.1740

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Sts-T Lithotripter, Model Sts-T

  Class II

  FDA 510(k) K010900 Active Cleared 5 Apr 2001

• Sts(Tm) Fluoroscopic Imaging Module

  Class II

  FDA 510(k) K905278 Active Cleared 4 Feb 1991

• Medstone STS Lithotripter

  Class III

  FDA PMA P970042 Withdrawn Approved 5 Sep 2000

• Medstone 1050 Extracorporeal Shock Wave Lithotriptor

  Class II

  FDA PMA P870015 Active Approved 15 Apr 1988

• What is the primary purpose of the UroPro 2000 Tomographic Option, and how does it integrate with existing systems?

  The UroPro 2000 Tomographic Option is designed as an optional add-on to the UroPro 2000 table, providing radiographic linear tomography capabilities for radiology procedures. It enhances the system’s functionality by enabling tomographic imaging, which is useful for detailed cross-sectional views in diagnostic imaging. This means it can be retrofitted or paired with the base UroPro 2000 system to offer advanced imaging without replacing the entire setup.

• Is the UroPro 2000 Tomographic Option intended for single-use or repeated use in clinical settings?

  The available data does not specify whether the UroPro 2000 Tomographic Option is single-use or reusable. Since it is classified as a Class II medical system and not described as disposable, it is likely intended for repeated use in radiology settings, though the manufacturer’s instructions or maintenance guidelines would provide clarity on cleaning, sterilization, or replacement protocols.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in hospitals?

  The UroPro 2000 Tomographic Option received FDA 510(k) clearance under K-number K013620, with a decision date of January 22, 2002. This means the device was deemed *substantially equivalent* to a legally marketed predicate device, allowing it to enter the market without requiring a full pre-market approval. Hospitals can use it with confidence that it meets FDA standards for safety and effectiveness, though they should verify compliance with their internal protocols and maintenance requirements.

• How is this device categorized in terms of medical specialty, and where would it typically be used?

  The UroPro 2000 Tomographic Option is regulated under the Federal Register regulation number 892.1740 and is categorized under the medical specialty of *Radiology*. It is intended for use in radiology departments where tomographic imaging is required, such as for detailed studies of anatomical structures like the urinary system or other areas needing cross-sectional visualization.

• Are there multiple models or variations of this device, and how can I identify the correct registration number for my facility?

  The UroPro 2000 Tomographic Option appears to have multiple registration numbers (e.g., 3001722928, 3027605321, etc.) associated with different units or variations, as listed under the OpenFDA data. These numbers correspond to individual devices registered with the FDA. To identify the correct registration number for your facility, check the device’s serial number or consult your facility’s medical equipment records, as these numbers help track compliance and maintenance history.