510(k) · Cleared
ClearedX3C 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. · KPR System, X-Ray, Stationary
Cleared on Jun 22, 2007 as substantially equivalent to K063039 (Imaging Dynamics Company, Ltd., 2006) after a 32-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Jun 22, 2007
- Review
- 32 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042041 (2004). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K063039 | Xplorer 2200 Digital Radiographic SystemSummary page 1…l Radiographic System, 3. Device Classification: Class 11,892.1680 (KPR), 892.1630 (MOB), 4. Predicate Device: Xplorer 2200 Digital Radiographic System (K063039) 5. Device Description: The X3C 2200 isa modification to Xplorer 2200 where the Xplorer 1000 digital radiographic det… | 2006 |
| † | K992955 | Xplorer 1000 | 2000 |
| † | K070079 | X3C Digital Radiographic Detector | 2007 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K063039.
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 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 X3C 2200 (510k submission device) is not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071401 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071401: X3C 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/K071401
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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