510(k) · Cleared
ClearedVidar Vision 3000 and 4000 X-Ray Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vidar Systems Corp. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 30, 2007 as substantially equivalent to K012546 (Sedecal USA, Inc., 2001) and 2 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1998. 4 later devices descend from it.
- Decided
- May 30, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K981556 (1998). 10 ancestors in all, the oldest K974863 (1998). 4 later devices descend from it, 2 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 deviceK071193 Vidar Vision 3000 and 4000 X-Ray SystemsVidar Systems Corp. · 2007
- Descendant · cites it directly · 2 of its ownK073114 Imix Insight X-Ray SystemsImix Adr Finland OY · 2008
- Descendant · 2 generations on · 1 of its ownK101435 Imix Panorad and SomaradImix Adr Finland OY · 2010
- Descendant · 3 generations on · 0 of its ownK113855 Panorad, Panorad SLImix Adr Finland OY · 2012
- Descendant · cites it directly · 0 of its ownK082261 Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd. · 2008
Most influential descendants
Showing 4 of 4 · See all- K073114Imix Insight X-Ray SystemsImix Adr Finland OY · 2008 · cites it directly2descendants
- K101435Imix Panorad and SomaradImix Adr Finland OY · 2010 · 2 generations on1descendant
- K113855Panorad, Panorad SLImix Adr Finland OY · 2012 · 3 generations on0descendants
- K082261Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd. · 2008 · cites it directly0descendants
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) | K071193 | Vidar Vision 3000 and 4000 X-Ray Systems | Vidar Systems Corp. | 2007 | — |
| +1 | K073114 | Imix Insight X-Ray Systems | Imix Adr Finland OY | 2008 | — |
| +2 | K101435 | Imix Panorad and Somarad | Imix Adr Finland OY | 2010 | — |
| +3 | K113855 | Panorad, Panorad SL | Imix Adr Finland OY | 2012 | — |
| +1 | K082261 | Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic Systems | Dxrad Solutions, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…ivalent legally marketed devices: This notification is for a MODIFIED device. This device COMBINES two 510(k) cleared devices, the SEDECAL Universal Radiographic Systems K012546 AND the Vidar 2000 Digital Radiographic Detector, K070563. This combination is functionally identical to a SEDECAL cleared device… | 2001 |
| * | K070563 | Vidar Vision 2000Summary page 1…a MODIFIED device. This device COMBINES two 510(k) cleared devices, the SEDECAL Universal Radiographic Systems K012546 AND the Vidar 2000 Digital Radiographic Detector, K070563. This combination is functionally identical to a SEDECAL cleared device, Sedecal URS LP X-Ray Units with Digital Detector, K04287… | 2007 |
| * | K042876 | Urs LP Digital, Millennium, RadproSummary page 1…ar 2000 Digital Radiographic Detector, K070563. This combination is functionally identical to a SEDECAL cleared device, Sedecal URS LP X-Ray Units with Digital Detector, K042876.. . Indications for Use (intended use) Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are indicated for use in gencrating… | 2004 |
| † | K031447 | Canon, Digital Radiography, Model Cxdi-50G | 2003 |
What descends from it? (4)
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 9 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K073114 (Imix Adr Finland OY, 2008) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K012546.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
The Vidar Vision 3000 and Vidar Vision 4000 is not indicated for diagnostic X-ray mammography.
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/K071193 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071193: Vidar Vision 3000 and 4000 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/K071193
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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