510(k) · Cleared
ClearedInnovision-Exii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dk Medical System · KPR System, X-Ray, Stationary
Cleared on Jan 3, 2025 as substantially equivalent to K202572 (DRGEM Corporation, 2020) after a 168-day review. Its family tree reaches back 9 generations to 1998. 2 later devices descend from it.
- Decided
- Jan 3, 2025
- Review
- 168 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K981556 (1998). 15 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations between
- 3 generations backK102408 Digital Diagnostic X-Ray SystemDRGEM Corporation · 2010
- 2 generations backK192364 GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 2019
- 1 generation backK202572 GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 2020
- This deviceK242119 Innovision-ExiiDk Medical System · 2025
- Descendant · cites it directly · 0 of its ownK253446 AeroDR TX c02Dk Medical Systems Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250790 Innovision-DxiiDk Medical Systems Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 8 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 7 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 6 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 5 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 4 generations backK090238 Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
- 3 generations backK102408 Digital Diagnostic X-Ray SystemDRGEM Corporation · 2010
- 2 generations backK192364 GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 2019
- 1 generation backK202572 GXR-Series Diagnostic X-Ray SystemDRGEM Corporation · 2020
- This deviceK242119 Innovision-ExiiDk Medical System · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −8 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −7 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −6 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −5 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −4 | K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | Sedecal., Sa. | 2009 | — |
| −3 | K102408 | Digital Diagnostic X-Ray System | DRGEM Corporation | 2010 | — |
| −2 | K192364 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2019 | — |
| −1 | K202572 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2020 | — |
| 0 (this device) | K242119 | Innovision-Exii | Dk Medical System | 2025 | — |
| +1 | K253446 | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | 2026 | — |
| +1 | K250790 | Innovision-Dxii | Dk Medical Systems Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 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 K260488 MULTIX Impact; MULTIX Impact Cscore 16.4 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K202572 | GXR-Series Diagnostic X-Ray SystemSummary page 5…KPR Regulatory Class Class II III. Predicate Device 510K Number K202572 Manufacturer DR GEM Device Name GXR-Series Diagnostic… | 2020 |
What descends from it? (2)
2 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 27 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K253446 (Dk Medical Systems Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K202572.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
INNOVISION-EXII is a stationery X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment.
INNOVISION-EXII is not intended for mammography, angiography, interventional, or fluoroscopy use.
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/K242119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242119: Innovision-Exii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242119
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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