510(k) · Cleared
ClearedDR Long Length Imaging Software
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 11, 2013 as substantially equivalent to K022881 (Cedara Software Corp., 2002) and 1 other predicate after a 99-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jun 11, 2013
- Review
- 99 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904519 (1991). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 3 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 2 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 1 generation backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- This deviceK130567 DR Long Length Imaging SoftwareCarestream Health, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −3 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −2 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −1 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| 0 (this device) | K130567 | DR Long Length Imaging Software | Carestream Health, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K022881 | Cedara I-SoftviewSummary page 1…e x-ray imager (flat panel/digital imager) Class Il MQB 21 CFR 892.1650 Cedara I-Softview'™ (Accustitch'™ component) Manufactured by Cedara Software Corp. 510(k) No. — K022881 (October 22, 2002) Kodak Eclipse Image Processing Software Manufactured by Carestream Health, Inc. 510(k) No. — K060137 (May 16,… | 2002 |
| * | K060137 | Kodak Eclipse Image Processing SoftwareSummary page 1…nufactured by Cedara Software Corp. 510(k) No. — K022881 (October 22, 2002) Kodak Eclipse Image Processing Software Manufactured by Carestream Health, Inc. 510(k) No. — K060137 (May 16, 2006) The DR Long Length Imaging Software is a software component for use on a diagnostic x-ray system utilizing digita… | 2006 |
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 22 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 5 other devices also cite its predicate K022881.
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 software’s intended use is to allow post-capture positioning and joining of individual images to produce an additional composite image. The software is sold only for use on Carestream Health system solutions and is available as an integrated feature within the DirectView software.
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/K130567 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130567: DR Long Length Imaging Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130567
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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