510(k) · Cleared
ClearedDRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health · KPR System, X-Ray, Stationary
Cleared on Jan 20, 2026 as substantially equivalent to K243556 (Iray Imaging Technology (Haining) Limited, 2025) and 2 other predicates after a 298-day review. Its family tree reaches back 17 generations to 1998.
- Decided
- Jan 20, 2026
- Review
- 298 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K981556 (1998). 55 ancestors in all, the oldest K803130 (1981). No later device cites it as a predicate yet.
- Root · 17 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 13 generations between
- 3 generations backK210314 Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2021
- 2 generations backK213529 Focus HD 43 DetectorIray Technology Taicang, Ltd. · 2022
- 1 generation backK243556 Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited · 2025
- This deviceK250954 DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System…Carestream Health · 2026
Show all 17 generations
- Root · 17 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 16 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 15 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 14 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 13 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 12 generations backK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- 11 generations backK102123 Vizion DRViztek, Inc. · 2011
- 10 generations backK112661 Vizion DRViztek, LLC · 2011
- 9 generations backK123644 Vizion + DRViztek, LLC · 2013
- 8 generations backK152279 ViZion DR + WirelessViztek, LLC · 2015
- 7 generations backK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
- 6 generations backK182551 Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2018
- 5 generations backK183713 Wireless Digital Flat DetectorIray Technology Taicang, Ltd. · 2019
- 4 generations backK201043 Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd. · 2020
- 3 generations backK210314 Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2021
- 2 generations backK213529 Focus HD 43 DetectorIray Technology Taicang, Ltd. · 2022
- 1 generation backK243556 Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited · 2025
- This deviceK250954 DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System…Carestream Health · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −16 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −15 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −14 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −13 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −12 | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| −11 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| −10 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| −9 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| −8 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
| −7 | K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai), Ltd. | 2016 | — |
| −6 | K182551 | Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | 2018 | — |
| −5 | K183713 | Wireless Digital Flat Detector | Iray Technology Taicang, Ltd. | 2019 | — |
| −4 | K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) | Iray Technology Taicang, Ltd. | 2020 | — |
| −3 | K210314 | Mars1717X Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | 2021 | — |
| −2 | K213529 | Focus HD 43 Detector | Iray Technology Taicang, Ltd. | 2022 | — |
| −1 | K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited | 2025 | — |
| 0 (this device) | K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35… | Carestream Health | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Summary page 5…Class II Device Code(s) KPR, MQB Regulation Number(s) 21 CFR 892.1680 Lux HD Detectors (K243556) DRX-Evolution Plus X-ray System (K233381) Predicate Device(s) DRX-Compass X-… | 2025 |
| * | K233381 | DRX-Evolution Plus SystemSummary page 5…er(s) 21 CFR 892.1680 Lux HD Detectors (K243556) DRX-Evolution Plus X-ray System (K233381) Predicate Device(s) DRX-Compass X-ray System (K223842)… | 2024 |
| * | K223842 | DRX - CompassSummary page 5…Lux HD Detectors (K243556) DRX-Evolution Plus X-ray System (K233381) Predicate Device(s) DRX-Compass X-ray System (K223842) P a g e 1|6… | 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 28 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 9 of the 55 ancestors have a recall of any class.
- 1 other device also cites its predicate K243556.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
DRX-Evolution Plus X-ray System The device is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography. DRX-Compass X-ray System The device is indicated for use in obtaining…
Read the full statement (179 words)
DRX-Evolution Plus X-ray System
The device is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography.
DRX-Compass X-ray System
The device is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen, and other body parts. The device is not indicated for use in mammography.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250954: DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250954
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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