510(k) · Cleared
ClearedDicompacs DX-R with Flat Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oehm Und Rehbein GmbH · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Aug 29, 2014 as substantially equivalent to K131211 (Oehm Und Rehbein GmbH, 2013) after an 88-day review. Its family tree reaches back 7 generations to 1981. 2 later devices descend from it.
- Decided
- Aug 29, 2014
- Review
- 88 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K803130 (1981). 24 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 6 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 4 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 3 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 2 generations backK083645 Radstar Family, Models: Radstar 4343 & Variations5 Star Medical, Inc. · 2009
- 1 generation backK131211 Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2013
- This deviceK141440 Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2014
- Descendant · cites it directly · 1 of its ownK142718 Radlink GPSRadlink, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
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 |
|---|---|---|---|---|---|
| −7 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −6 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −5 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −4 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −3 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −2 | K083645 | Radstar Family, Models: Radstar 4343 & Variations | 5 Star Medical, Inc. | 2009 | — |
| −1 | K131211 | Dicompacs DX-R with Flat Panel | Oehm Und Rehbein GmbH | 2013 | — |
| 0 (this device) | K141440 | Dicompacs DX-R with Flat Panel | Oehm Und Rehbein GmbH | 2014 | — |
| +1 | K142718 | Radlink GPS | Radlink, Inc. | 2014 | — |
| +2 | K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K131211 | Dicompacs DX-R with Flat PanelSummary page 4…Imager (Flat Panel/Digital Imager) Classification: Class II Product codes: MQB at 21 CFR Part 892.1680 LLZ at 21 CFR Part 892.2050 Predicate devices: K131211, dicomPACS®DX-R; Oehm und Rehbein GmbH. Description of the The dicomPACS®DX-R with flat panel digital imaging system consists… | 2013 |
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 |
|---|---|---|---|
| K142718 | Radlink GPS | 2014 | 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 6 companies; a new generation was cleared every 3.3 years on median.
- 10 of the 24 ancestors have a recall of any class.
- Of its descendants, K142718 (Radlink, Inc., 2014) has gone furthest, with 1 descendant of its own.
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. 2014, 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 dicompacs dx-r with flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141440: Dicompacs DX-R with Flat Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141440
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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