510(k) · Cleared
ClearedDunlee Format Collimator Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · IZW Collimator, Automatic, Radiographic
Cleared on Jul 21, 2003 as substantially equivalent to K990423 (Philips Medical Systems, Inc., 1999) after a 61-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.
- Decided
- Jul 21, 2003
- Review
- 61 days
- Class
- Class II
- Product code
- IZW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990423 (1999). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK990423 Philips Nicol Collimator FamilyPhilips Medical Systems, Inc. · 1999
- This deviceK031597 Dunlee Format Collimator FamilyPhilips Medical Systems North America Co. · 2003
- Descendant · cites it directly · 4 of its ownK050092 R605 Facs CollimeterOmega Medical Imaging, Inc. · 2005
- Descendant · 2 generations on · 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 · 3 generations on · 0 of its ownK091517 Ralco, Model R225 AcsRalco S.R.L. · 2009
- Descendant · 2 generations on · 0 of its ownK083029 Model R605DASM Automatic X-Ray CollimatorRalco S.R.L. · 2008
Most influential descendants
Showing 5 of 5 · See all- K050092R605 Facs CollimeterOmega Medical Imaging, Inc. · 2005 · cites it directly4descendants
- K072780Model R302DACS/a Automatic X-Ray CollimatorRalco S.R.L. · 2007 · 2 generations on2descendants
- K093572R650 Qdasm CollimatorOmega Medical Imaging, Inc. · 2010 · cites it directly0descendants
- K091517Ralco, Model R225 AcsRalco S.R.L. · 2009 · 3 generations on0descendants
- K083029Model R605DASM Automatic X-Ray CollimatorRalco S.R.L. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990423 | Philips Nicol Collimator Family | Philips Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K031597 | Dunlee Format Collimator Family | Philips Medical Systems North America Co. | 2003 | — |
| +1 | K050092 | R605 Facs Collimeter | Omega Medical Imaging, Inc. | 2005 | — |
| +2 | K072780 | Model R302DACS/a Automatic X-Ray Collimator | Ralco S.R.L. | 2007 | — |
| +1 | K093572 | R650 Qdasm Collimator | Omega Medical Imaging, Inc. | 2010 | — |
| +3 | K091517 | Ralco, Model R225 Acs | Ralco S.R.L. | 2009 | — |
| +2 | K083029 | Model R605DASM Automatic X-Ray Collimator | Ralco S.R.L. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990423 | Philips Nicol Collimator FamilySummary page 1…collimator family manufactured by Philips Medical Systems, which has been determined to be substantially equivalent to legally marketed predicate devices under number K990423. Device description: The Dunlee "FORMAT" collimator family is a family of Beam-Limiting Devices, which comprises both manual and… | 1999 |
| * | — | Pre-amendment manual collimators with codenumbers 9804 602 60501 and 9804 602 61501 (BRH… Named without a submission number |
What descends from it? (5)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K050092 (Omega Medical Imaging, Inc., 2005) has gone furthest, with 4 descendants of its own.
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 Format collimator family will be used in Radiography, Fluoroscopy, Cardio and Vascular X-ray systems. It has the following functionality (configuration dependant): X-ray field limitation (rectangular, and circular); rectangular shuttering in some configurations with direct user control at the collimator head (direct shutter control) Simulation of X-ray field by a light field Measurement of source image distance (with an electronic or mechanical…
Read the full statement (137 words)
The Format collimator family will be used in Radiography, Fluoroscopy, Cardio and Vascular X-ray systems. It has the following functionality (configuration dependant):
X-ray field limitation (rectangular, and circular); rectangular shuttering in some configurations with direct user control at the collimator head (direct shutter control)
Simulation of X-ray field by a light field
Measurement of source image distance (with an electronic or mechanical ruler)
Spectral filtering
Wedge filtering (semi-transparent filtering)
Dose measurement (Area Exposure Product Measurement device)
Format family consists of a manual version and automatic versions. The product configuration of the automatic version depends on the configuration of the X-ray system. It's a modular concept in which collimator functionalities can be added for radiographic or fluoroscopy applications.
The automatic collimators have an ISO-CAN software interface with the system through which they receive system commands at openclose level.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031597 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031597: Dunlee Format Collimator Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031597
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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