510(k) · Cleared
ClearedXaminer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Dynamics Company, Ltd. · KPR System, X-Ray, Stationary
Cleared on Aug 17, 2006 after a 70-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Aug 17, 2006
- Review
- 70 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK061595 XaminerImaging Dynamics Company, Ltd. · 2006
- Descendant · cites it directly · 4 of its ownK073056 Digital Radiography System, Model: QXR-9Vieworks Co., Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK080553 Digital Radiography System, Model QXR-16Vieworks Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK101779 Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK100703 Stationary X-Ray System (Detector) Model: AltasComed Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK093816 Digital Radiography System, Models Galaxy 900 and 1600Medien International Co, Ltd. · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K073056Digital Radiography System, Model: QXR-9Vieworks Co., Ltd. · 2007 · cites it directly4descendants
- K080553Digital Radiography System, Model QXR-16Vieworks Co., Ltd. · 2008 · 2 generations on2descendants
- K101779Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd. · 2011 · 2 generations on0descendants
- K100703Stationary X-Ray System (Detector) Model: AltasComed Co., Ltd. · 2010 · cites it directly0descendants
- K093816Digital Radiography System, Models Galaxy 900 and 1600Medien International Co, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061595 | Xaminer | Imaging Dynamics Company, Ltd. | 2006 | — |
| +1 | K073056 | Digital Radiography System, Model: QXR-9 | Vieworks Co., Ltd. | 2007 | — |
| +2 | K080553 | Digital Radiography System, Model QXR-16 | Vieworks Co., Ltd. | 2008 | — |
| +2 | K101779 | Clearvision DR 2000 Digital Radiography X-Ray System | Jpi Healthcare Co, Ltd. | 2011 | — |
| +1 | K100703 | Stationary X-Ray System (Detector) Model: Altas | Comed Co., Ltd. | 2010 | — |
| +1 | K093816 | Digital Radiography System, Models Galaxy 900 and 1600 | Medien International Co, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | — | Xplorer 1000 Digital Radiographic x-ray detector Named without a submission number |
What descends from it? (6)
3 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?
- Of its descendants, K073056 (Vieworks Co., Ltd., 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Xaminer (510k submission device) is integrated into the user’s stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe 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 in an integrated system.
The Xaminer (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/K061595 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061595: Xaminer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061595
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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