510(k) · Cleared
ClearedSedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems
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 Feb 27, 2009 as substantially equivalent to K042876 (Sedecal., Sa., 2004) and 5 other predicates after a 25-day review. Its family tree reaches back 5 generations to 1998. 46 later devices descend from it.
- Decided
- Feb 27, 2009
- Review
- 25 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K981556 (1998). 11 ancestors in all. 46 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 4 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 3 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 2 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 1 generation backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- This deviceK090238 Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
- Descendant · cites it directly · 18 of its ownK092830 Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd. · 2010
- Descendant · cites it directly · 17 of its ownK102408 Digital Diagnostic X-Ray SystemDRGEM Corporation · 2010
- Descendant · 2 generations on · 17 of its ownK091090 Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology · 2010
- Descendant · 3 generations on · 13 of its ownK142475 EVS 4343DRTECH Corporation · 2015
- Descendant · 2 generations on · 11 of its ownK192364 GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 2019
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K092830Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd. · 2010 · cites it directly18descendants
- K102408Digital Diagnostic X-Ray SystemDRGEM Corporation · 2010 · cites it directly17descendants
- K091090Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology · 2010 · 2 generations on17descendants
- K142475EVS 4343DRTECH Corporation · 2015 · 3 generations on13descendants
- K192364GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 2019 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −4 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −3 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −2 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −1 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| 0 (this device) | K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | Sedecal., Sa. | 2009 | — |
| +1 | K092830 | Digital X-Ray Imaging System, Model DRC-1000 | VATECH Co., Ltd. | 2010 | — |
| +1 | K102408 | Digital Diagnostic X-Ray System | DRGEM Corporation | 2010 | — |
| +2 | K091090 | Digital Flat Panel X-Ray Detector, Model Xmaru 1717 | E-Woo Technology | 2010 | — |
| +3 | K142475 | EVS 4343 | DRTECH Corporation | 2015 | — |
| +2 | K192364 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (6)
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 |
|---|---|---|---|
| * | K042876 | Urs LP Digital, Millennium, RadproSummary page 1…mager (Flat Panel/Digital Imager) 90 MQB, Common/Usual Name: Digital Stationary Diagnostic X-Ray System 2. Equivalent legally marketed device: Sedecal URS LP Digital K042876 and Sedecal X Plus LP Plus, K062335. Digital panels: Canon, K060433 (50C); K031633 (40C); K031447 (50G); K023750 (40G). 3… | 2004 |
| * | K062335 | Sedecal X Plus LP PlusSummary page 1…B, Common/Usual Name: Digital Stationary Diagnostic X-Ray System 2. Equivalent legally marketed device: Sedecal URS LP Digital K042876 and Sedecal X Plus LP Plus, K062335. Digital panels: Canon, K060433 (50C); K031633 (40C); K031447 (50G); K023750 (40G). 3. Indications for Use (intended use) Th… | 2006 |
| * | K060433 | Digital Radiography Cxdi-50CSummary page 1…Stationary Diagnostic X-Ray System 2. Equivalent legally marketed device: Sedecal URS LP Digital K042876 and Sedecal X Plus LP Plus, K062335. Digital panels: Canon, K060433 (50C); K031633 (40C); K031447 (50G); K023750 (40G). 3. Indications for Use (intended use) These Digital Radiographic Systems… | 2006 |
| * | K031633 | Canon Inc., Digital Radiography, Model Cxdi-40CSummary page 1…gnostic X-Ray System 2. Equivalent legally marketed device: Sedecal URS LP Digital K042876 and Sedecal X Plus LP Plus, K062335. Digital panels: Canon, K060433 (50C); K031633 (40C); K031447 (50G); K023750 (40G). 3. Indications for Use (intended use) These Digital Radiographic Systems are intended f… | 2003 |
| * | K031447 | Canon, Digital Radiography, Model Cxdi-50GSummary page 1…ystem 2. Equivalent legally marketed device: Sedecal URS LP Digital K042876 and Sedecal X Plus LP Plus, K062335. Digital panels: Canon, K060433 (50C); K031633 (40C); K031447 (50G); K023750 (40G). 3. Indications for Use (intended use) These Digital Radiographic Systems are intended for use by a… | 2003 |
| * | K023750 | Cannon Digital Radiography Model Cxdi-40GSummary page 1…nt legally marketed device: Sedecal URS LP Digital K042876 and Sedecal X Plus LP Plus, K062335. Digital panels: Canon, K060433 (50C); K031633 (40C); K031447 (50G); K023750 (40G). 3. Indications for Use (intended use) These Digital Radiographic Systems are intended for use by a qualified/trained… | 2002 |
What descends from it? (46)
See all 465 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 11 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K092830 (VATECH Co., Ltd., 2010) has gone furthest, with 18 descendants of its own.
- 7 other devices also cite its predicate K042876.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
These Digital Radiographic Systems 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 as stated in the FDA summary.
https://510kreport.com/device/K090238 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090238: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090238
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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