510(k) · Cleared
ClearedX3C 1600 Plus Digital Radiographic System
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 Jun 8, 2007 as substantially equivalent to K062586 (Imaging Dynamics Company, Ltd., 2006) after an 18-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.
- Decided
- Jun 8, 2007
- Review
- 18 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062586 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK062586 Xplorer 1600 PlusImaging Dynamics Company, Ltd. · 2006
- This deviceK071402 X3C 1600 Plus Digital Radiographic SystemImaging Dynamics Company, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK111098 Innovaxion FP, Innovaxion FP 1600 Plus, MagellanImaging Dynamics Company, Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K111098Innovaxion FP, Innovaxion FP 1600 Plus, MagellanImaging Dynamics Company, Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062586 | Xplorer 1600 Plus | Imaging Dynamics Company, Ltd. | 2006 | — |
| 0 (this device) | K071402 | X3C 1600 Plus Digital Radiographic System | Imaging Dynamics Company, Ltd. | 2007 | — |
| +1 | K111098 | Innovaxion FP, Innovaxion FP 1600 Plus, Magellan | Imaging Dynamics Company, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K062586 | Xplorer 1600 PlusSummary page 1…1600 Plus Digital Radiographic System, Device Classification: Class Il, 892.1680 (KPR), 892.1630 (MQB), Predicate Device: Xplorer 1600 Plus Digital Radiographic System (K062586) Device Description: The X3C 1600 Plus is a modification to Xplorer 1600 Plus where the Xplorer 1000 digital radiographic detect… | 2006 |
| † | K992955 | Xplorer 1000 | 2000 |
| † | K070079 | X3C Digital Radiographic Detector | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111098 | Innovaxion FP, Innovaxion FP 1600 Plus, Magellan | 2011 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K111098 (Imaging Dynamics Company, Ltd., 2011) has gone furthest, with 0 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. 2007, 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 X3C 1600 PLUS 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 X3C 1600 Plus (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/K071402 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071402: X3C 1600 Plus Digital Radiographic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071402
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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