510(k) · Cleared
ClearedShimadzu 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 Dec 3, 2004 as substantially equivalent to K031771 (Shimadzu Corp., 2003) after a 50-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Dec 3, 2004
- Review
- 50 days
- Class
- Class II
- Product code
- IZX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031771 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK031771 Shimadzu Collimator R-30HShimadzu Corp. · 2003
- This deviceK042840 Shimadzu Collimator R-20JShimadzu Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031771 | Shimadzu Collimator R-30H | Shimadzu Corp. | 2003 | — |
| 0 (this device) | K042840 | Shimadzu Collimator R-20J | Shimadzu Corp. | 2004 | — |
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? (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 |
|---|---|---|---|
| * | K031771 | Shimadzu Collimator R-30HSummary page 3…ent populations. As mentioned at "Intended Use" in this clearance letter, the intended use of the R-20J is the same as that of predicate beam limiting device R-30H (K031771). Consequently, the indications for use of the R-20J are also the same as that of the beam limiting device R-30H (K031771) a… | 2003 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K031771.
How does its category compare?
All IZX devicesIZX Collimator, Manual, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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 intended to be used in the radiology. This device is operated and used by Physicians and X-ray technologist. The object of this device is total patient populations. As mentioned at "Intended Use" in…
Read the full statement (128 words)
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 intended to be used in the radiology.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the R-20J is the same as that of predicate beam limiting device R-30H (K031771).
Consequently, the indications for use of the R-20J are also the same as that of the beam limiting device R-30H (K031771) and there are no additional indications.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042840: Shimadzu Collimator R-20J.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042840
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026