# K013620: Medstone, Uropro 2000, Tomographic Option

- Pathway: 510(k) (Traditional)
- Applicant: Medstone Intl., Inc.
- Decided: Jan 22, 2002 after 78 days
- Product code: IZF (System, X-Ray, Tomographic)
- Device class: 2
- Regulation: 21 CFR 892.1740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pausch Corporation Microtom, Tomographic Option: named in the summary without a submission number

## Indications for use
The Medstone, Radiographic Linear Tomography Option is designed as an optional additional device to the Medstone UroPro 2000 table, intended for use in general radiology. It is designed to enable the production of diagnostic radiologic images of a specific linear cross- sectional plane of the body, eliminating unwanted anatomy and detail by motion blurring of other planes. This device is designed to provide and control the sweep speed and angle of a tomography function to enable the production of a properly imaged X-ray film to accomplish diagnostic imaging of a patient. The table and tomography option are intended to be used by trained professionals, schooled in proper radiology procedures, techniques, positioning and safety.

Source page: https://510kreport.com/device/K013620
Methodology: https://510kreport.com/methodology