510(k) · Cleared
ClearedXplorer 2200 Digital Radiographic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Dynamics Company, Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 2, 2006 as substantially equivalent to K042041 (Imaging Dynamics Company Limited, 2004) after a 30-day review. Its family tree reaches back 1 generation to 2004. 4 later devices descend from it.
- Decided
- Nov 2, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042041 (2004). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK042041 Xplorer 1600Imaging Dynamics Company Limited · 2004
- This deviceK063039 Xplorer 2200 Digital Radiographic SystemImaging Dynamics Company, Ltd. · 2006
- Descendant · cites it directly · 2 of its ownK073632 Intuition, Model 0170Arcoma AB · 2008
- Descendant · 2 generations on · 0 of its ownK140683 0180 Intuition, 0072 PrecisionArcoma AB · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK121109 Aerodr X70Konica Minolta Medical & Graphic, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK071401 X3C 2200 Digital Radiographic SystemImaging Dynamics Company, Ltd. · 2007
Most influential descendants
Showing 4 of 4 · See all- K073632Intuition, Model 0170Arcoma AB · 2008 · cites it directly2descendants
- K1406830180 Intuition, 0072 PrecisionArcoma AB · 2014 · 2 generations on0descendants
- K121109Aerodr X70Konica Minolta Medical & Graphic, Inc. · 2012 · 2 generations on0descendants
- K071401X3C 2200 Digital Radiographic SystemImaging Dynamics Company, Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042041 | Xplorer 1600 | Imaging Dynamics Company Limited | 2004 | — |
| 0 (this device) | K063039 | Xplorer 2200 Digital Radiographic System | Imaging Dynamics Company, Ltd. | 2006 | — |
| +1 | K073632 | Intuition, Model 0170 | Arcoma AB | 2008 | — |
| +2 | K140683 | 0180 Intuition, 0072 Precision | Arcoma AB | 2014 | 2 |
| +2 | K121109 | Aerodr X70 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| +1 | K071401 | X3C 2200 Digital Radiographic System | Imaging Dynamics Company, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K042041 | Xplorer 1600Summary page 1…ax: 403 251 1771 Oct 30, 2006 Xplorer 2200 Digital Radiographic System, Class I, 892.1630 (MQB), 892.1680 (KPR), 892.1980 (122) Xplorer 1600 Digital Radiographic System (K042041) The Xplorer 2200 is a combination of two Xplorer 1000 CCD imagers, a previously marketed device covered by 510k K992955. One i… | 2004 |
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?
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.
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 Xplorer 2200 is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.
The Xplorer 2200 (510k submission device) is not intended for 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/K063039 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063039: Xplorer 2200 Digital Radiographic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063039
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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