510(k) · Cleared
ClearedMedstone, Uropro 2000, Tomographic Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medstone Intl., Inc. · IZF System, X-Ray, Tomographic
Cleared on Jan 22, 2002 after a 78-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 22, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- IZF
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZF device
- #1 K250850 Nanox.ARC Xscore 15.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Pausch Corporation Microtom, Tomographic Option Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All IZF devicesIZF System, X-Ray, Tomographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZF
Too few IZF 510(k)s in any year since 2007 to give a median.
Recalls per year · IZF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZF
1in 2021
MAUDE reports naming product code IZF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 24 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (113 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013620 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013620: Medstone, Uropro 2000, Tomographic Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013620
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026