510(k) · Cleared
ClearedMiniCAT 2D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xoran Technologies, LLC · KPR System, X-Ray, Stationary
Cleared on Nov 20, 2020 as substantially equivalent to K141837 (Carestream Health, Inc., 2015) after a 141-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Nov 20, 2020
- Review
- 141 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K020635 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK020635 Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview…Eastman Kodak Company · 2002 · Recalled
- 3 generations backK090318 Carestream DRX-1 SystemCarestream Health, Inc. · 2009 · Recalled
- 2 generations backK091889 DRX-Evolution, Model VX3733-SysCarestream Health, Inc. · 2009 · Recalled
- 1 generation backK141837 DRX-EvolutionCarestream Health, Inc. · 2015 · Recalled
- This deviceK201825 MiniCAT 2DXoran Technologies, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020635 | Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900… | Eastman Kodak Company | 2002 | 1 |
| −3 | K090318 | Carestream DRX-1 System | Carestream Health, Inc. | 2009 | 2 |
| −2 | K091889 | DRX-Evolution, Model VX3733-Sys | Carestream Health, Inc. | 2009 | 3 |
| −1 | K141837 | DRX-Evolution | Carestream Health, Inc. | 2015 | 1 |
| 0 (this device) | K201825 | MiniCAT 2D | Xoran Technologies, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K141837 | DRX-EvolutionSummary page 4…vice Class: Class II Product Code: KPR Predicate Devices: Trade Name: Carestream DRX-Evolution 510(k) number: K141837 cleared 03/11/2015 Manufacturer: Carestream Health, Inc. Classification Name: Stationary X-Ray System Cl… | 2015 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 5 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K141837.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 MiniCAT 2D is a diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201825: MiniCAT 2D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201825
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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