510(k) · Cleared
ClearedVidar Vision 2000
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 Mar 16, 2007 as substantially equivalent to K974863 (Advanced Instrument Development, Inc., 1998) after a 17-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.
- Decided
- Mar 16, 2007
- Review
- 17 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974863 (1998). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974863 Imix Digital Thorax SystemAdvanced Instrument Development, Inc. · 1998
- This deviceK070563 Vidar Vision 2000Vidar Systems Corp. · 2007
- Descendant · cites it directly · 4 of its ownK071193 Vidar Vision 3000 and 4000 X-Ray SystemsVidar Systems Corp. · 2007
- Descendant · 2 generations on · 2 of its ownK073114 Imix Insight X-Ray SystemsImix Adr Finland OY · 2008
- Descendant · 3 generations on · 1 of its ownK101435 Imix Panorad and SomaradImix Adr Finland OY · 2010
- Descendant · 4 generations on · 0 of its ownK113855 Panorad, Panorad SLImix Adr Finland OY · 2012
- Descendant · 2 generations on · 0 of its ownK082261 Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd. · 2008
Most influential descendants
Showing 5 of 5 · See all- K071193Vidar Vision 3000 and 4000 X-Ray SystemsVidar Systems Corp. · 2007 · cites it directly4descendants
- K073114Imix Insight X-Ray SystemsImix Adr Finland OY · 2008 · 2 generations on2descendants
- K101435Imix Panorad and SomaradImix Adr Finland OY · 2010 · 3 generations on1descendant
- K113855Panorad, Panorad SLImix Adr Finland OY · 2012 · 4 generations on0descendants
- K082261Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974863 | Imix Digital Thorax System | Advanced Instrument Development, Inc. | 1998 | — |
| 0 (this device) | K070563 | Vidar Vision 2000 | Vidar Systems Corp. | 2007 | — |
| +1 | K071193 | Vidar Vision 3000 and 4000 X-Ray Systems | Vidar Systems Corp. | 2007 | — |
| +2 | K073114 | Imix Insight X-Ray Systems | Imix Adr Finland OY | 2008 | — |
| +3 | K101435 | Imix Panorad and Somarad | Imix Adr Finland OY | 2010 | — |
| +4 | K113855 | Panorad, Panorad SL | Imix Adr Finland OY | 2012 | — |
| +2 | K082261 | Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic Systems | Dxrad Solutions, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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? (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 |
|---|---|---|---|
| * | K974863 | Imix Digital Thorax SystemSummary page 2…discussion, Dr. Phillips suggested that VIDAR request a letter from IMIX (Tampere, Finland) permitting VIDAR to include by reference the data submitted by IMIX to FDA in K974863. Unfortunately, the agreement between VIDAR and IMIX did not extend to the exchange of such information so the present submissio… | 1998 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071193 | Vidar Vision 3000 and 4000 X-Ray Systems | 2007 | 4 |
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?
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?
The VIDAR Vision 2000 is indicated for use in generating radiographic images of human anatomy. It is a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
The VIDAR Vision 2000 is not indicated for diagnostic X-ray mammography.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070563: Vidar Vision 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070563
Report an extraction error
Are you the manufacturer?
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