510(k) · Cleared
ClearedModel R605DASM Automatic X-Ray Collimator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ralco S.R.L. · IZW Collimator, Automatic, Radiographic
Cleared on Dec 5, 2008 as substantially equivalent to K072780 (Ralco S.R.L., 2007) and 1 other predicate after a 56-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Dec 5, 2008
- Review
- 56 days
- Class
- Class II
- Product code
- IZW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K990423 (1999). 7 ancestors in all, the oldest K820306 (1982). No later device cites it as a predicate yet.
- Root · 4 generations backK990423 Philips Nicol Collimator FamilyPhilips Medical Systems, Inc. · 1999
- 3 generations backK031597 Dunlee Format Collimator FamilyPhilips Medical Systems North America Co. · 2003
- 2 generations backK050092 R605 Facs CollimeterOmega Medical Imaging, Inc. · 2005
- 1 generation backK072780 Model R302DACS/a Automatic X-Ray CollimatorRalco S.R.L. · 2007
- This deviceK083029 Model R605DASM Automatic X-Ray CollimatorRalco S.R.L. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990423 | Philips Nicol Collimator Family | Philips Medical Systems, Inc. | 1999 | — |
| −3 | K031597 | Dunlee Format Collimator Family | Philips Medical Systems North America Co. | 2003 | — |
| −2 | K050092 | R605 Facs Collimeter | Omega Medical Imaging, Inc. | 2005 | — |
| −1 | K072780 | Model R302DACS/a Automatic X-Ray Collimator | Ralco S.R.L. | 2007 | — |
| 0 (this device) | K083029 | Model R605DASM Automatic X-Ray Collimator | Ralco S.R.L. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1990 | 1 | 0 |
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 IZW? 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? (2)
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 |
|---|---|---|---|
| * | K072780 | Model R302DACS/a Automatic X-Ray CollimatorSummary page 1…Classification Name: collimator, automatic, radiographic, Product Code IZW Common/Usual Name: Automatic X-Ray Collimator. 2. Equivalent legally marketed devices: K072780, Ralco Model R302DACS Automatic Collimator, K050092, Omega Medical Imaging, Inc Automatic Beam Limiting Device Model R605FA… | 2007 |
| * | K050092 | R605 Facs CollimeterSummary page 1…phic, Product Code IZW Common/Usual Name: Automatic X-Ray Collimator. 2. Equivalent legally marketed devices: K072780, Ralco Model R302DACS Automatic Collimator, K050092, Omega Medical Imaging, Inc Automatic Beam Limiting Device Model R605FACS. 3. Indications for Use (intended use): Intended fo… | 2005 |
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?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K072780.
How does its category compare?
All IZW devicesIZW Collimator, Automatic, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IZW
2in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · IZW
Too few IZW 510(k)s in any year since 2007 to give a median.
Recalls per year · IZW
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZW
1in 2024
MAUDE reports naming product code IZW, 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 | 2 | — | 1 | 2 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 1 |
| 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 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Model R605DASM Automatic X-RAY Collimator is intended for use in
diagnostic radiographic/fluoroscopic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083029 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083029: Model R605DASM Automatic X-Ray Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083029
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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