510(k) · Cleared
Recalled · Class II · 2013DRX-Evolution, Model VX3733-Sys
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 Jul 20, 2009 as substantially equivalent to K051258 (Eastman Kodak Company, 2005) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 2002. 30 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 20, 2009
- Review
- 26 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K020635 (2002). 3 ancestors in all. 30 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK020635 Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview…Eastman Kodak Company · 2002 · Recalled
- 1 generation backK090318 Carestream DRX-1 SystemCarestream Health, Inc. · 2009 · Recalled
- This deviceK091889 DRX-Evolution, Model VX3733-SysCarestream Health, Inc. · 2009
- Descendant · cites it directly · 29 of its ownK141837 DRX-EvolutionCarestream Health, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 26 of its ownK160997 GC85ASamsung Electronics Co., Ltd. · 2016
- Descendant · 3 generations on · 23 of its ownK163115 GC70Samsung Electronics Co., Ltd. · 2016
- Descendant · 3 generations on · 23 of its ownK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
- Descendant · 4 generations on · 22 of its ownK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K141837DRX-EvolutionCarestream Health, Inc. · 2015 · cites it directly29descendants
- K160997GC85ASamsung Electronics Co., Ltd. · 2016 · 2 generations on26descendants
- K163115GC70Samsung Electronics Co., Ltd. · 2016 · 3 generations on23descendants
- K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016 · 3 generations on23descendants
- K171119GM85Samsung Electronics Co., Ltd. · 2017 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020635 | Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900… | Eastman Kodak Company | 2002 | 1 |
| −1 | K090318 | Carestream DRX-1 System | Carestream Health, Inc. | 2009 | 2 |
| 0 (this device) | K091889 | DRX-Evolution, Model VX3733-Sys | Carestream Health, Inc. | 2009 | — |
| +1 | K141837 | DRX-Evolution | Carestream Health, Inc. | 2015 | 1 |
| +2 | K160997 | GC85A | Samsung Electronics Co., Ltd. | 2016 | — |
| +3 | K163115 | GC70 | Samsung Electronics Co., Ltd. | 2016 | — |
| +3 | K162278 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2016 | — |
| +4 | K171119 | GM85 | Samsung Electronics Co., Ltd. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 8 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K051258 | Kodak Directview DR 7500 System, Model 8791345Summary page 1…Kodak DirectView DR 7500 Manufactured by Carestream Health, Inc. 510(k) No. - K051258 (June 1, 2005) AND Carestream DRX- 1 System… | 2005 |
| * | K090318 | Carestream DRX-1 SystemSummary page 1…Carestream DRX- 1 System Manufactured by CarestreamHealth, Inc. 5 10(k) No. - K090318 (April 6, 2009) Device Description: The DRX-Evolution is a diagnostic x-ray system utilizing digital radiography (DR) technolog… | 2009 |
What descends from it? (30)
See all 301 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141837 | DRX-Evolution | 2015 | 29 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2013 | Class II | Z-0797-2014 | Nonconforming Material/Component | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. |
| Nov 25, 2013 | Class II | Z-0796-2014 | Nonconforming Material/Component | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. |
| Jun 3, 2013 | Class II | Z-1877-2013 | Radiation Control for Health and Safety Act | Due to potential for an x-ray exposure technique change. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K141837 (Carestream Health, Inc., 2015) has gone furthest, with 29 descendants of its own.
- 1 other device also cites its predicate K051258.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091889: DRX-Evolution, Model VX3733-Sys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091889
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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