510(k) · Cleared
ClearedCarestream DRX-1 System with DRX 2530C Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jun 7, 2013 as substantially equivalent to K090318 (Carestream Health, Inc., 2009) after a 105-day review. Its family tree reaches back 2 generations to 2002. 17 later devices descend from it.
- Decided
- Jun 7, 2013
- Review
- 105 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020635 (2002). 17 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 deviceK130464 Carestream DRX-1 System with DRX 2530C DetectorCarestream Health, Inc. · 2013
- Descendant · cites it directly · 16 of its ownK150766 Carestream DRX-1 SystemCarestream Health, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK162555 Evs 4343, Evs 4343GDRTECH Corporation · 2016
- Descendant · 3 generations on · 6 of its ownK192400 Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation · 2019
- Descendant · 2 generations on · 3 of its ownK162552 Evs 3643, Evs 3643GDRTECH Corporation · 2016
- Descendant · 4 generations on · 2 of its ownK223124 Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K150766Carestream DRX-1 SystemCarestream Health, Inc. · 2015 · cites it directly16descendants
- K162555Evs 4343, Evs 4343GDRTECH Corporation · 2016 · 2 generations on7descendants
- K192400Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation · 2019 · 3 generations on6descendants
- K162552Evs 3643, Evs 3643GDRTECH Corporation · 2016 · 2 generations on3descendants
- K223124Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation · 2022 · 4 generations on2descendants
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) | K130464 | Carestream DRX-1 System with DRX 2530C Detector | Carestream Health, Inc. | 2013 | — |
| +1 | K150766 | Carestream DRX-1 System | Carestream Health, Inc. | 2015 | — |
| +2 | K162555 | Evs 4343, Evs 4343G | DRTECH Corporation | 2016 | — |
| +3 | K192400 | Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AG | DRTECH Corporation | 2019 | — |
| +2 | K162552 | Evs 3643, Evs 3643G | DRTECH Corporation | 2016 | — |
| +4 | K223124 | Expd 86P, Expd 86PG, Expd 129P, Expd 129PG | DRTECH Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 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 |
|---|---|---|---|
| * | K090318 | Carestream DRX-1 SystemSummary page 1…X-Ray Imager (Flat Panel/Digital Imager) Class 11 MQB 21 CFR 892.1650 Carestream DRX-1 System (w/ DRX-1 Detector) Manufactured by Carestream Health, Inc. 510(k) No. — K090318 (April 6, 2009) The Carestream DRX-1 System is a diagnostic imaging system utilizing digital radiography (DR) technology that is… | 2009 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150766 | Carestream DRX-1 System | 2015 | 16 |
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 11 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K150766 (Carestream Health, Inc., 2015) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K090318.
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. 2013, 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/K130464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130464: Carestream DRX-1 System with DRX 2530C Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130464
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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