510(k) · Cleared
ClearedUrs LP Digital, Millennium, Radpro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedecal., Sa. · KPR System, X-Ray, Stationary
Cleared on Nov 18, 2004 as substantially equivalent to K012546 (Sedecal USA, Inc., 2001) and 1 other predicate after a 31-day review. Its family tree reaches back 4 generations to 1998. 138 later devices descend from it.
- Decided
- Nov 18, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981556 (1998). 7 ancestors in all. 138 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 3 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 2 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 1 generation backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- This deviceK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- Descendant · cites it directly · 46 of its ownK090238 Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
- Descendant · cites it directly · 41 of its ownK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- Descendant · 2 generations on · 36 of its ownK102123 Vizion DRViztek, Inc. · 2011
- Descendant · 3 generations on · 34 of its ownK112661 Vizion DRViztek, LLC · 2011
- Descendant · 4 generations on · 33 of its ownK123644 Vizion + DRViztek, LLC · 2013
Showing 5 of 138 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 138 · See all- K090238Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009 · cites it directly46descendants
- K082604Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008 · cites it directly41descendants
- K102123Vizion DRViztek, Inc. · 2011 · 2 generations on36descendants
- K112661Vizion DRViztek, LLC · 2011 · 3 generations on34descendants
- K123644Vizion + DRViztek, LLC · 2013 · 4 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −3 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −2 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −1 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| 0 (this device) | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| +1 | K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | Sedecal., Sa. | 2009 | — |
| +1 | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| +2 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| +3 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| +4 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 14 | 0 |
| 2020 | 10 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 7 | 0 |
| 2024 | 4 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K012546 | Optima Urs Universal Radiographic SystemSummary page 1…em, Product Codes Product Code 90 KPR and MQB Common/Usual Name: General purpose diagnostic X-ray Unit. . Equivalent legally marketed devices: Sedecal URS X-Ray Units K012546 and Canon CXDI-50G Digital Radiography, K031447. The MODIFIED device COMBINES these two units. . Indications for Use (intended u… | 2001 |
| * | K031447 | Canon, Digital Radiography, Model Cxdi-50GSummary page 1…Common/Usual Name: General purpose diagnostic X-ray Unit. . Equivalent legally marketed devices: Sedecal URS X-Ray Units K012546 and Canon CXDI-50G Digital Radiography, K031447. The MODIFIED device COMBINES these two units. . Indications for Use (intended use) The Sedecal URS LP/Millennium/RadPro X- ray… | 2003 |
What descends from it? (138)
See all 1388 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | 2009 | 46 |
| K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | 2008 | 41 |
| K090279 | Sedecal, Millennium Plus | 2009 | 17 |
| K080582 | Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FA | 2008 | 16 |
| K063283 | Definium 5000 X-Ray System | 2006 | 14 |
| K071193 | Vidar Vision 3000 and 4000 X-Ray Systems | 2007 | 4 |
| K073114 | Imix Insight X-Ray Systems | 2008 | 2 |
| K073650 | Fujifilm Unity Speedsuite, Model CR-IR 371 | 2008 | 0 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K090238 (Sedecal., Sa., 2009) has gone furthest, with 46 descendants of its own.
- 6 other devices also cite its predicate K012546.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The URS LP/Miliennium/RadPro Radiographic Systems with Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
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/K042876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042876: Urs LP Digital, Millennium, Radpro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042876
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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