510(k) · Cleared
ClearedPhilips Nicol Collimator Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · IZW Collimator, Automatic, Radiographic
Cleared on Mar 15, 1999 after a 32-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Mar 15, 1999
- Review
- 32 days
- Class
- Class II
- Product code
- IZW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK990423 Philips Nicol Collimator FamilyPhilips Medical Systems, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK031597 Dunlee Format Collimator FamilyPhilips Medical Systems North America Co. · 2003
- Descendant · 2 generations on · 4 of its ownK050092 R605 Facs CollimeterOmega Medical Imaging, Inc. · 2005
- Descendant · 3 generations on · 2 of its ownK072780 Model R302DACS/a Automatic X-Ray CollimatorRalco S.R.L. · 2007
- Descendant · 2 generations on · 0 of its ownK093572 R650 Qdasm CollimatorOmega Medical Imaging, Inc. · 2010
- Descendant · 4 generations on · 0 of its ownK091517 Ralco, Model R225 AcsRalco S.R.L. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031597Dunlee Format Collimator FamilyPhilips Medical Systems North America Co. · 2003 · cites it directly5descendants
- K050092R605 Facs CollimeterOmega Medical Imaging, Inc. · 2005 · 2 generations on4descendants
- K072780Model R302DACS/a Automatic X-Ray CollimatorRalco S.R.L. · 2007 · 3 generations on2descendants
- K093572R650 Qdasm CollimatorOmega Medical Imaging, Inc. · 2010 · 2 generations on0descendants
- K091517Ralco, Model R225 AcsRalco S.R.L. · 2009 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990423 | Philips Nicol Collimator Family | Philips Medical Systems, Inc. | 1999 | — |
| +1 | K031597 | Dunlee Format Collimator Family | Philips Medical Systems North America Co. | 2003 | — |
| +2 | K050092 | R605 Facs Collimeter | Omega Medical Imaging, Inc. | 2005 | — |
| +3 | K072780 | Model R302DACS/a Automatic X-Ray Collimator | Ralco S.R.L. | 2007 | — |
| +2 | K093572 | R650 Qdasm Collimator | Omega Medical Imaging, Inc. | 2010 | — |
| +4 | K091517 | Ralco, Model R225 Acs | Ralco S.R.L. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Philips Galileo Automatic Collimator Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031597 | Dunlee Format Collimator Family | 2003 | 5 |
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?
- Of its descendants, K031597 (Philips Medical Systems North America Co., 2003) has gone furthest, with 5 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 Philips NICOL Collimator is intended for use in diagnostic x-ray systems during
radiographic and fluoroscopic examinations. The collimator restricts the dimensions of
the diagnostic x-ray field by limiting the size of the primary x-ray beam.
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/K990423 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990423: Philips Nicol Collimator Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990423
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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