510(k) · Cleared
ClearedCollimare Collimator Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collimare, LLC · IZW Collimator, Automatic, Radiographic
Cleared on Nov 16, 2007 as substantially equivalent to K810598 (Midmark Corp., 1981) and 1 other predicate after a 10-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Nov 16, 2007
- Review
- 10 days
- Class
- Class II
- Product code
- IZW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K810598 (1981). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK810598 X-Ray Collimating DevicesMidmark Corp. · 1981
- This deviceK073124 Collimare Collimator FamilyCollimare, LLC · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810598 | X-Ray Collimating Devices | Midmark Corp. | 1981 | — |
| 0 (this device) | K073124 | Collimare Collimator Family | Collimare, LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K810598 | X-Ray Collimating DevicesSummary page 1…Device Classification Regulation Number: IZX & IZW Classification CommitteelPanel: Radiology Predicate Devices: X-Ray Collimating Devices K81 0598 Manufactured by Eureka X-Ray Tube AXT150OMC K97… | 1981 |
| * | K972966 | Axt 150M Manual Collimator (Axt 150M)Summary page 1…X-Ray Collimating Devices K81 0598 Manufactured by Eureka X-Ray Tube AXT150OMC K972966 Manufactured by Applied X-Ray Technologies Description: The Collimare "Collimator Famil… | 1997 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All IZW devicesIZW Collimator, Automatic, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment during radiographic and fluoroscopic procedures. It is designed to be adapted to various x-ray systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073124: Collimare Collimator Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073124
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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