510(k) · Cleared
ClearedLux 35 Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Dec 2, 2020 as substantially equivalent to K150766 (Carestream Health, Inc., 2015) after a 40-day review. Its family tree reaches back 4 generations to 2002. 1 later device descends from it.
- Decided
- Dec 2, 2020
- Review
- 40 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K020635 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK020635 Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview…Eastman Kodak Company · 2002 · Recalled
- 3 generations backK090318 Carestream DRX-1 SystemCarestream Health, Inc. · 2009 · Recalled
- 2 generations backK130464 Carestream DRX-1 System with DRX 2530C DetectorCarestream Health, Inc. · 2013
- 1 generation backK150766 Carestream DRX-1 SystemCarestream Health, Inc. · 2015
- This deviceK203159 Lux 35 DetectorCarestream Health · 2020
- Descendant · cites it directly · 0 of its ownK253185 Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream Health · 2026
Most influential descendants
Showing 1 of 1 · See all- K253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream Health · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020635 | Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900… | Eastman Kodak Company | 2002 | 1 |
| −3 | K090318 | Carestream DRX-1 System | Carestream Health, Inc. | 2009 | 2 |
| −2 | K130464 | Carestream DRX-1 System with DRX 2530C Detector | Carestream Health, Inc. | 2013 | — |
| −1 | K150766 | Carestream DRX-1 System | Carestream Health, Inc. | 2015 | — |
| 0 (this device) | K203159 | Lux 35 Detector | Carestream Health | 2020 | — |
| +1 | K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K150766 | Carestream DRX-1 SystemSummary page 4…fications to the DRX Plus 3543 Flat Panel Detector. Caresteam believes the modified DRX Plus 3543C Flat Panel Detector is substantially equivalent to the cleared device (K150766). Date Summary Prepared: August 15 2020 Predicate Subje… | 2015 |
| † | K090318 | Carestream DRX-1 System | 2009 |
| † | K130464 | Carestream DRX-1 System with DRX 2530C Detector | 2013 |
| † | K183425 | Cardiovit at-102 G2 | 2020 |
| † | K180809 | Eclipse II | 2018 |
| † | K163203 | Carestream DRX-Evolution | 2016 |
| † | K191205 | DRX-Mobile Revolution System with Image View Software | |
| † | K201373 | DRX-Compass | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | 2026 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K253185 (Carestream Health, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K150766.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
“The device is intended to capture for display radiographic images of human anatomy including both pediatric and adult patients. The device is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. Excluded from the indications for use are mammography, fluoroscopy, and angiography applications”.
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/K203159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203159: Lux 35 Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203159
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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