510(k) · Cleared
ClearedKDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta Healthcare Americas, Inc. · KPR System, X-Ray, Stationary
Cleared on Jan 15, 2020 as substantially equivalent to K082604 (Viztek, Inc., 2008) after a 54-day review. Its family tree reaches back 6 generations to 1998. 2 later devices descend from it.
- Decided
- Jan 15, 2020
- Review
- 54 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K981556 (1998). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 4 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 3 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 2 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 1 generation backK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- This deviceK193225 KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography…Konica Minolta Healthcare Americas, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK214012 Straight Arm DDRKonica Minolta Healthcare Americas, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK221853 Otc DDRKonica Minolta Healthcare Americas, Inc. · 2022
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 |
|---|---|---|---|---|---|
| −6 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −5 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −4 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −3 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −2 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −1 | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| 0 (this device) | K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU… | Konica Minolta Healthcare Americas, Inc. | 2020 | — |
| +1 | K214012 | Straight Arm DDR | Konica Minolta Healthcare Americas, Inc. | 2022 | — |
| +2 | K221853 | Otc DDR | Konica Minolta Healthcare Americas, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000Summary page 4…eries Digital Diagnostic Digital X-Ray Systems Viztek, Inc K082604 Reference Devices: AERODR SYSTEM WITH P-21 (K113248)… | 2008 |
| † | K113248 | Aerodr System with P-21 | 2012 |
| † | K172793 | SKR 3000 | 2017 |
| † | K182688 | SKR 3000 | 2018 |
| † | K190146 | Nexus DR Digital X-ray Imaging System | 2019 |
| † | K151924 | Q-Rad Radiographic System with Auto-Tracker Option | 2015 |
| † | K182973 | DigitalDiagnost C90 | 2019 |
| † | K133139 | Vizion Ultra | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214012 | Straight Arm DDR | 2022 | 1 |
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 22 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K214012 (Konica Minolta Healthcare Americas, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K082604.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial 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 (not for mammography).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193225: KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193225
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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