510(k) · Cleared
ClearedLux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health · IZL System, X-Ray, Mobile
Cleared on Mar 11, 2026 as substantially equivalent to K241505 (Carestream Health, Inc., 2024) and 3 other predicates after a 166-day review. Its family tree reaches back 5 generations to 2002.
- Decided
- Mar 11, 2026
- Review
- 166 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K020635 (2002). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK020635 Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview…Eastman Kodak Company · 2002 · Recalled
- 4 generations backK090318 Carestream DRX-1 SystemCarestream Health, Inc. · 2009 · Recalled
- 3 generations backK130464 Carestream DRX-1 System with DRX 2530C DetectorCarestream Health, Inc. · 2013
- 2 generations backK150766 Carestream DRX-1 SystemCarestream Health, Inc. · 2015
- 1 generation backK153142 Carestream DRX-1 System with DRX Plus 4343 DetectorsCarestream Health, Inc. · 2015
- This deviceK253185 Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream Health · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K020635 | Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900… | Eastman Kodak Company | 2002 | 1 |
| −4 | K090318 | Carestream DRX-1 System | Carestream Health, Inc. | 2009 | 2 |
| −3 | K130464 | Carestream DRX-1 System with DRX 2530C Detector | Carestream Health, Inc. | 2013 | — |
| −2 | K150766 | Carestream DRX-1 System | Carestream Health, Inc. | 2015 | — |
| −1 | K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors | Carestream Health, Inc. | 2015 | — |
| 0 (this device) | K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 IZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K241505 | DRX-Revolution Mobile X-ray SystemSummary page 6…olution Mobile X-ray system will support the new Lux HD Detectors with the DEC function (K243556), additionally the detectors will also support the optional SNC feature (K241505). Carestream Mobile X-ray Systems DRX-Revolution Mobile X-Ray System is a mobile diagnostic x-ray system that utilizes digital t… | 2024 |
| * | K153142 | Carestream DRX-1 System with DRX Plus 4343 DetectorsSummary page 8…Detector (K250954) DRX Plus 3543C, Lux HD 35 (K243556) Lux HD 35 (K243556) Lux HD DQE/MTF data are 4343C (K153142) Lux HD 43 (K243556) Lux HD 43 (K243556) similar; any differences Compatible DRX Plus 2530C DRX… | 2015 |
| * | K183245 | Carestream DRX-1 System with DRX Plus 2530 DetectorsSummary page 8…similar; any differences Compatible DRX Plus 2530C DRX-LC (K230059) DRX-LC (K230059) confirmed by verification and Digital Flat (K183245) validation testing and do not Panel Lux 35 Detector… | 2019 |
| * | K203159 | Lux 35 DetectorSummary page 8…validation testing and do not Panel Lux 35 Detector impact image quality. Detectors (K203159) The detectors being added are… | 2020 |
| * | — | Lux HD Detectors Named without a submission number | |
| † | K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector… | 2026 |
| † | K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | 2025 |
| † | K230059 | Digital Flat Panel Detector | 2023 |
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 24 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 11 ancestors have a recall of any class.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, 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 | 3 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
DRX-Revolution Mobile X-ray System The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas. Lux HD Detectors Lux HD 35 Detector and Lux HD 43 Detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general–purpose…
Read the full statement (138 words)
DRX-Revolution Mobile X-ray System
The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
Lux HD Detectors
Lux HD 35 Detector and Lux HD 43 Detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general–purpose diagnostic procedures. Lux HD 35 Detector and Lux HD 43 Detector are not intended for mammography or dental applications.
DRX-LC Detector
DRX-LC, as a major imaging component, are supplied to the manufacturers of medical diagnostic X-ray photography systems and used in conjunction with the medical diagnostic X-ray photography system to image the object to be checked. They are capable of outputting the acquired static images to a processing device after acquisition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253185: Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253185
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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