510(k) · Cleared
ClearedR650 Qdasm Collimator
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 Feb 3, 2010 as substantially equivalent to K031597 (Philips Medical Systems North America Co., 2003) and 1 other predicate after a 77-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Feb 3, 2010
- Review
- 77 days
- Class
- Class II
- Product code
- IZW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K990423 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK990423 Philips Nicol Collimator FamilyPhilips Medical Systems, Inc. · 1999
- 2 generations backK031597 Dunlee Format Collimator FamilyPhilips Medical Systems North America Co. · 2003
- 1 generation backK050092 R605 Facs CollimeterOmega Medical Imaging, Inc. · 2005
- This deviceK093572 R650 Qdasm CollimatorOmega Medical Imaging, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990423 | Philips Nicol Collimator Family | Philips Medical Systems, Inc. | 1999 | — |
| −2 | K031597 | Dunlee Format Collimator Family | Philips Medical Systems North America Co. | 2003 | — |
| −1 | K050092 | R605 Facs Collimeter | Omega Medical Imaging, Inc. | 2005 | — |
| 0 (this device) | K093572 | R650 Qdasm Collimator | Omega Medical Imaging, Inc. | 2010 | — |
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 |
|---|---|---|---|
| * | K031597 | Dunlee Format Collimator FamilySummary page 1…ass II (Procode: 90 IZW) Predicate device: *Dunlee automatic 'FORMAT A' collimator manufactured by Philips Medical Systems legally marketed under number K031597. Omega Model R605 FAGS collimators manufactured by RALCO S.R.L legally marketed under number K050092 Device descr… | 2003 |
| * | K050092 | R605 Facs CollimeterSummary page 1…edical Systems legally marketed under number K031597. Omega Model R605 FAGS collimators manufactured by RALCO S.R.L legally marketed under number K050092 Device description: The Omega R 650 QOASMV is an automatic beam limiting device designed for use in diagnostic radiographic/fluor… | 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 11 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 3 ancestors has a recall.
- 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. 2010, 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?
The Omega R650 ODASM automatic beam limiting device is intended for use in X-ray diagnostic radiographic/fluoroscopic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093572: R650 Qdasm Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093572
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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