510(k) · Cleared
ClearedDRX-Evolution/Plus with Dual Energy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · KPR System, X-Ray, Stationary
Cleared on Nov 4, 2019 as substantially equivalent to K163203 (Carestream Health, Inc., 2016) and 1 other predicate after a 263-day review. Its family tree reaches back 5 generations to 1986. 2 later devices descend from it.
- Decided
- Nov 4, 2019
- Review
- 263 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K862120 (1986). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 4 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 3 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 2 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK013481 Dual Energy and Tissue Equalization Software OptionGE Medical Systems · 2001
- This deviceK190330 DRX-Evolution/Plus with Dual EnergyCarestream Health, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK233381 DRX-Evolution Plus SystemCarestream Health, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK250954 DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System…Carestream Health · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −4 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −3 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −2 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −1 | K013481 | Dual Energy and Tissue Equalization Software Option | GE Medical Systems | 2001 | — |
| 0 (this device) | K190330 | DRX-Evolution/Plus with Dual Energy | Carestream Health, Inc. | 2019 | — |
| +1 | K233381 | DRX-Evolution Plus System | Carestream Health, Inc. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 1988 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K163203 | Carestream DRX-EvolutionSummary page 4…R Regulation Number: 21 CFR 892.1680 Manufactured by: Carestream Health, Inc. 510(k) No.: K163203 (12/13/2016) Secondary Predicate Device: Dual Energy and Tissue Equalization Software Option Device Common Name:… | 2016 |
| * | K013481 | Dual Energy and Tissue Equalization Software OptionSummary page 4…ion Number: 21 CFR 892.1680 Manufactured by: General Electric Medical Systems 510(k) No.: K013481 (11/02/2001) AG5257 Template No. 9J9055 Page 1 of 6 Device… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233381 | DRX-Evolution Plus System | 2024 | 1 |
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 33 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K233381 (Carestream Health, Inc., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. This device also supports dual energy chest imaging. The tomography and dual energy features are not to be used for imaging pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190330: DRX-Evolution/Plus with Dual Energy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190330
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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