510(k) · Cleared
ClearedSedecal Digital Radiographic Upgrade Model Sdru-T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedecal., Sa. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Apr 18, 2013 as substantially equivalent to K112527 (Meridian Medical Systems, LLC, 2012) and 2 other predicates after a 20-day review. Its family tree reaches back 8 generations to 1990. 11 later devices descend from it.
- Decided
- Apr 18, 2013
- Review
- 20 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K896095 (1990). 29 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 2 generations backK110040 OmnivisionModern Module, Inc. · 2011
- 1 generation backK112132 Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011
- This deviceK130883 Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013
- Descendant · cites it directly · 7 of its ownK140825 Delworks DR SystemDel Medical, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017
- Descendant · 2 generations on · 5 of its ownK192541 DigiX FDXAllengers Medical Systems Limited · 2019
- Descendant · 3 generations on · 4 of its ownK223060 DigiX FDXAllengers Medical Systems Limited · 2022
- Descendant · 4 generations on · 3 of its ownK230985 Planmeca VisoPlanmeca Oy · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K140825Delworks DR SystemDel Medical, Inc. · 2014 · cites it directly7descendants
- K162529DigiX FDXAllengers Medical Systems Limited · 2017 · cites it directly6descendants
- K192541DigiX FDXAllengers Medical Systems Limited · 2019 · 2 generations on5descendants
- K223060DigiX FDXAllengers Medical Systems Limited · 2022 · 3 generations on4descendants
- K230985Planmeca VisoPlanmeca Oy · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −2 | K110040 | Omnivision | Modern Module, Inc. | 2011 | — |
| −1 | K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit System | Medicatech USA | 2011 | — |
| 0 (this device) | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-T | Sedecal., Sa. | 2013 | — |
| +1 | K140825 | Delworks DR System | Del Medical, Inc. | 2014 | — |
| +1 | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
| +2 | K192541 | DigiX FDX | Allengers Medical Systems Limited | 2019 | — |
| +3 | K223060 | DigiX FDX | Allengers Medical Systems Limited | 2022 | — |
| +4 | K230985 | Planmeca Viso | Planmeca Oy | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K112527 | Universal Digital Interface (Udi) 1717Summary page 1…roduct Code: MQB) 3. Equivalent legally marketed device: This device uses the same digital x-ray panels as: Meridian Medical Universal Digital Interface UDI 1717, KI 112527 OR Meridian Medical Universal Digital Interface Wireless - UDI 1417W, K I111305 and uses the same software as the Medicatec… | 2012 |
| * | K111305 | Universal Digital Interface Wireless - Udi 1417WSummary page 1…digital x-ray panels as: Meridian Medical Universal Digital Interface UDI 1717, KI 112527 OR Meridian Medical Universal Digital Interface Wireless - UDI 1417W, K I111305 and uses the same software as the Medicatech Krvstalrad 660. K 112 132. 4. Description of the Device: This Digital Radiograph… | 2012 |
| * | K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit SystemSummary page 1…ce UDI 1717, KI 112527 OR Meridian Medical Universal Digital Interface Wireless - UDI 1417W, K I111305 and uses the same software as the Medicatech Krvstalrad 660. K 112 132. 4. Description of the Device: This Digital Radiographic Upgrade is intended for those radiographic examination roomis where… | 2011 |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 7 of the 29 ancestors have a recall of any class.
- Of its descendants, K140825 (Del Medical, Inc., 2014) has gone furthest, with 7 descendants 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. 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?
Sedlecal Digital Radiographic Upgrade Model SDRU-T is intended for digital image capture use in general radiographic examinations, wherever conventional screenflm systems may be used, excluding fluoroscopy. angiography and mammography. The kit allows imaging of the skull, chest, shoulders. spine, abdomen, pelvis, and extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130883: Sedecal Digital Radiographic Upgrade Model Sdru-T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130883
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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