510(k) · Cleared
ClearedDigital Radiography System, Models Galaxy 900 and 1600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medien International Co, Ltd. · KPR System, X-Ray, Stationary
Cleared on Oct 5, 2010 as substantially equivalent to K061595 (Imaging Dynamics Company, Ltd., 2006) and 1 other predicate after a 298-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Oct 5, 2010
- Review
- 298 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K974863 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974863 | Imix Digital Thorax System | Advanced Instrument Development, Inc. | 1998 | — |
| −1 | K992955 | Xplorer 1000 | Imaging Dynamics Corp. | 2000 | — |
| 0 (this device) | K093816 | Digital Radiography System, Models Galaxy 900 and 1600 | Medien International Co, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K061595 | XaminerSummary page 1…tem 3. Predicate Devices: Manufacturer :Imaging Dynamics Co., Ltd. Device .Xaminer 510(k) Number :K061 595(Decision Date - 8. 17. 2006) 4. Classifications Names & Citations: 21ICPR 892.1680, KPR - Stationary X-ray System, Class… | 2006 |
| * | K992955 | Xplorer 1000Summary page 4…Predicate Devices: Manufacturer Imaging Dynamics Co., Ltd. Device .Xplorer1000 510(k) Number :K992955 (Decision Date - 2. 6. 2000) 12. Classifications Names & Citations: 21CFR 892.1680, KPR - Stationary X-ray Sys… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K061595.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Galaxy 900 is integrated into the users 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 sifting, standing or lying in the prone or supine positions in an integrated system. The Galaxy 900 is not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093816 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093816: Digital Radiography System, Models Galaxy 900 and 1600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093816
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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