510(k) · Cleared
ClearedViztek DR, Models: DR1000, DR3000, DR4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viztek, Inc. · KPR System, X-Ray, Stationary
Cleared on Nov 21, 2008 as substantially equivalent to K042876 (Sedecal., Sa., 2004) and 1 other predicate after a 74-day review. Its family tree reaches back 5 generations to 1998. 41 later devices descend from it.
- Decided
- Nov 21, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K981556 (1998). 9 ancestors in all. 41 later devices descend from it, 3 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 deviceK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- Descendant · cites it directly · 36 of its ownK102123 Vizion DRViztek, Inc. · 2011
- Descendant · 2 generations on · 34 of its ownK112661 Vizion DRViztek, LLC · 2011
- Descendant · 3 generations on · 33 of its ownK123644 Vizion + DRViztek, LLC · 2013
- Descendant · 4 generations on · 27 of its ownK152279 ViZion DR + WirelessViztek, LLC · 2015
- Descendant · 5 generations on · 24 of its ownK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K102123Vizion DRViztek, Inc. · 2011 · cites it directly36descendants
- K112661Vizion DRViztek, LLC · 2011 · 2 generations on34descendants
- K123644Vizion + DRViztek, LLC · 2013 · 3 generations on33descendants
- K152279ViZion DR + WirelessViztek, LLC · 2015 · 4 generations on27descendants
- K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016 · 5 generations on24descendants
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) | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| +1 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| +2 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| +3 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| +4 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
| +5 | K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai), Ltd. | 2016 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2025 | 2 | 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 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 |
|---|---|---|---|
| * | K042876 | Urs LP Digital, Millennium, RadproSummary page 1…ger) 90 MQB, Common/Usual Name: Digital Stationary Diagnostic X-Ray System 2. Equivalent legally marketed device: URS LP Digital, Millennium, Radpro (Sedecal) K042876, and SmartRad (CMT Medical Technologies) K003438. 3. Indications for Use (intended use) This digital radiographic system is inte… | 2004 |
| * | K003438 | Smart RadSummary page 1…nary Diagnostic X-Ray System 2. Equivalent legally marketed device: URS LP Digital, Millennium, Radpro (Sedecal) K042876, and SmartRad (CMT Medical Technologies) K003438. 3. Indications for Use (intended use) This digital radiographic system is intended for use by a qualified/trained doctor or… | 2001 |
What descends from it? (41)
See all 413 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 10 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K102123 (Viztek, Inc., 2011) has gone furthest, with 36 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. 2008, 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?
This Digital Radiographic System is 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/K082604 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082604: Viztek DR, Models: DR1000, DR3000, DR4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082604
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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