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 Nov 5, 2013 as substantially equivalent to K083645 (5 Star Medical, Inc., 2009) after a 190-day review. Its family tree reaches back 6 generations to 1981. 3 later devices descend from it.
- Decided
- Nov 5, 2013
- Review
- 190 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K803130 (1981). 23 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 5 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 3 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 2 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 1 generation backK083645 Radstar Family, Models: Radstar 4343 & Variations5 Star Medical, Inc. · 2009
- This deviceK131211 Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2013
- Descendant · cites it directly · 2 of its ownK141440 Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH · 2014
- Descendant · 2 generations on · 1 of its ownK142718 Radlink GPSRadlink, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −5 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −4 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −3 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −2 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −1 | K083645 | Radstar Family, Models: Radstar 4343 & Variations | 5 Star Medical, Inc. | 2009 | — |
| 0 (this device) | K131211 | Dicompacs DX-R with Flat Panel | Oehm Und Rehbein GmbH | 2013 | — |
| +1 | K141440 | Dicompacs DX-R with Flat Panel | Oehm Und Rehbein GmbH | 2014 | — |
| +2 | K142718 | Radlink GPS | Radlink, Inc. | 2014 | — |
| +3 | 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 | 2 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083645 | Radstar Family, Models: Radstar 4343 & VariationsSummary page 1…Classification: Class 11 Product code: MOB at 21 CFR Part 892.1650 LLZ at 21 CFR Part 892.2050 Predicate devices: K083645 RadStar Digital Imaging System (5-Star Medical, Inc.) K1O02349 AeroDR System (Konica Minolta Medical &… | 2009 |
| Kept off the family tree | K100234 | FDA’s K100234 is HM-Lamp II Our reading of the summary gave K100234, FDA’s number for HM-Lamp II (Hillusa, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “AeroDR System”. Kept off the family tree. | 2010 |
| † | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141440 | Dicompacs DX-R with Flat Panel | 2014 | 2 |
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 32 years and passes through 6 companies; a new generation was cleared every 4.7 years on median.
- 10 of the 23 ancestors have a recall of any class.
- Of its descendants, K141440 (Oehm Und Rehbein GmbH, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K083645.
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 dicomPACS®1 DX-R with fiat 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/K131211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131211: 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/K131211
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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