510(k) · Cleared
ClearedR605 Facs Collimeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Medical Imaging, Inc. · IZW Collimator, Automatic, Radiographic
Cleared on Jan 31, 2005 as substantially equivalent to K031597 (Philips Medical Systems North America Co., 2003) after a 17-day review. Its family tree reaches back 2 generations to 1999. 4 later devices descend from it.
- Decided
- Jan 31, 2005
- Review
- 17 days
- Class
- Class II
- Product code
- IZW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K990423 (1999). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK990423 Philips Nicol Collimator FamilyPhilips Medical Systems, Inc. · 1999
- 1 generation backK031597 Dunlee Format Collimator FamilyPhilips Medical Systems North America Co. · 2003
- This deviceK050092 R605 Facs CollimeterOmega Medical Imaging, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK072780 Model R302DACS/a Automatic X-Ray CollimatorRalco S.R.L. · 2007
- Descendant · cites it directly · 0 of its ownK093572 R650 Qdasm CollimatorOmega Medical Imaging, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK091517 Ralco, Model R225 AcsRalco S.R.L. · 2009
- Descendant · cites it directly · 0 of its ownK083029 Model R605DASM Automatic X-Ray CollimatorRalco S.R.L. · 2008
Most influential descendants
Showing 4 of 4 · See all- K072780Model R302DACS/a Automatic X-Ray CollimatorRalco S.R.L. · 2007 · cites it directly2descendants
- K093572R650 Qdasm CollimatorOmega Medical Imaging, Inc. · 2010 · cites it directly0descendants
- K091517Ralco, Model R225 AcsRalco S.R.L. · 2009 · 2 generations on0descendants
- K083029Model R605DASM Automatic X-Ray CollimatorRalco S.R.L. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990423 | Philips Nicol Collimator Family | Philips Medical Systems, Inc. | 1999 | — |
| −1 | K031597 | Dunlee Format Collimator Family | Philips Medical Systems North America Co. | 2003 | — |
| 0 (this device) | K050092 | R605 Facs Collimeter | Omega Medical Imaging, Inc. | 2005 | — |
| +1 | K072780 | Model R302DACS/a Automatic X-Ray Collimator | Ralco S.R.L. | 2007 | — |
| +1 | K093572 | R650 Qdasm Collimator | Omega Medical Imaging, Inc. | 2010 | — |
| +2 | K091517 | Ralco, Model R225 Acs | Ralco S.R.L. | 2009 | — |
| +1 | K083029 | Model R605DASM Automatic X-Ray Collimator | Ralco S.R.L. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031597 | Dunlee Format Collimator FamilySummary page 1…hic/fluoroscopic Collimator Predicate device: * Dunlee automatic "FORMAT A" collimator manufactured by Philips Medical Systems legally marketed under number K031597. * Advantech Model R600/800 series collimators manufactured by RALCO S.R.L legally marketed under number K904182 Devi… | 2003 |
| Kept off the family tree | K040182 | Advantech Model R600/800 series collimators Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072780 (Ralco S.R.L., 2007) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K031597.
How does its category compare?
All IZW devicesIZW Collimator, Automatic, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
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/K050092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050092: R605 Facs Collimeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050092
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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