510(k) · Cleared
ClearedUniversal Digital Interface (Udi) 1717
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Medical Systems, LLC · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 22, 2012 after a 265-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.
- Decided
- May 22, 2012
- Review
- 265 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK112527 Universal Digital Interface (Udi) 1717Meridian Medical Systems, LLC · 2012
- Descendant · cites it directly · 11 of its ownK130883 Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013
- Descendant · 2 generations on · 7 of its ownK140825 Delworks DR SystemDel Medical, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017
- Descendant · 3 generations on · 5 of its ownK192541 DigiX FDXAllengers Medical Systems Limited · 2019
- Descendant · 4 generations on · 4 of its ownK223060 DigiX FDXAllengers Medical Systems Limited · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013 · cites it directly11descendants
- K140825Delworks DR SystemDel Medical, Inc. · 2014 · 2 generations on7descendants
- K162529DigiX FDXAllengers Medical Systems Limited · 2017 · 2 generations on6descendants
- K192541DigiX FDXAllengers Medical Systems Limited · 2019 · 3 generations on5descendants
- K223060DigiX FDXAllengers Medical Systems Limited · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112527 | Universal Digital Interface (Udi) 1717 | Meridian Medical Systems, LLC | 2012 | — |
| +1 | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-T | Sedecal., Sa. | 2013 | — |
| +2 | K140825 | Delworks DR System | Del Medical, Inc. | 2014 | — |
| +2 | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
| +3 | K192541 | DigiX FDX | Allengers Medical Systems Limited | 2019 | — |
| +4 | K223060 | DigiX FDX | Allengers Medical Systems Limited | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-T | 2013 | 11 |
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?
- Of its descendants, K130883 (Sedecal., Sa., 2013) has gone furthest, with 11 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. 2012, 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 UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital…
Read the full statement (146 words)
The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17." x 17" sensor plate capture large patient imaging and areas.
For the review of parts of the anatomy (legs, spine, etc.) that exceed the panel's dimensions, several Images can also be "stitched" together to allow the review of this part of the anatomy as one single image.
The UDI 1717 cannot be used for Mammography applications.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K112527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112527: Universal Digital Interface (Udi) 1717.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112527
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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