510(k) · Cleared
ClearedDRX-Evolution with Carestream Digital Tomosynthesis
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 Dec 20, 2019 as substantially equivalent to K141837 (Carestream Health, Inc., 2015) after a 158-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Dec 20, 2019
- Review
- 158 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K020635 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 backK091889 DRX-Evolution, Model VX3733-SysCarestream Health, Inc. · 2009 · Recalled
- 1 generation backK141837 DRX-EvolutionCarestream Health, Inc. · 2015 · Recalled
- This deviceK191879 DRX-Evolution with Carestream Digital TomosynthesisCarestream Health, Inc. · 2019
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 | K091889 | DRX-Evolution, Model VX3733-Sys | Carestream Health, Inc. | 2009 | 3 |
| −1 | K141837 | DRX-Evolution | Carestream Health, Inc. | 2015 | 1 |
| 0 (this device) | K191879 | DRX-Evolution with Carestream Digital Tomosynthesis | Carestream Health, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (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 |
|---|---|---|---|
| * | K141837 | DRX-EvolutionSummary page 4…n with Linear Tomography Predicate Device: Manufactured by: Carestream Health, Inc. Systems 510(k) No.: K141837 (3/11/2015) 21 CFR 892.1680; KPR Reference Device: FUJIFILM Medical Systems U.S… | 2015 |
| † | K121499 | Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System | 2012 |
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 17 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 5 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K141837.
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 digital tomosynthesis. The tomography and digital tomosynthesis features are not to be used for imaging pediatric patients.
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/K191879 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191879: DRX-Evolution with Carestream Digital Tomosynthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191879
Report an extraction error
Are you the manufacturer?
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