510(k) · Cleared
Recalled · Class II · 2011Shimadzu Collimator R-20J
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Corp. · IZX Collimator, Manual, Radiographic
Cleared on Aug 26, 2010 after a 134-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Aug 26, 2010
- Review
- 134 days
- Class
- Class II
- Product code
- IZX
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2011 | Class II | Z-0261-2013 | Nonconforming Material/Component | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All IZX devicesIZX Collimator, Manual, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IZX
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · IZX
Too few IZX 510(k)s in any year since 2007 to give a median.
Recalls per year · IZX
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZX
1in 2014
MAUDE reports naming product code IZX, 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 | — | 3 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is intended to be used in radiology.
This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.
This device is for diagnostic use.
This device is operated and used by Physicians and X-Ray technologist.
The object of this device is total patient populations.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K101036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101036: Shimadzu Collimator R-20J.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101036
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026