510(k) · Cleared
Recalled · Class II · 20210180 Intuition, 0072 Precision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arcoma AB · KPR System, X-Ray, Stationary
Cleared on Jun 3, 2014 as substantially equivalent to K073632 (Arcoma AB, 2008) after a 77-day review. Its family tree reaches back 3 generations to 2004. It has been recalled 2 times.
- Decided
- Jun 3, 2014
- Review
- 77 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042041 (2004). 5 ancestors in all, the oldest K011486 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK042041 Xplorer 1600Imaging Dynamics Company Limited · 2004
- 2 generations backK063039 Xplorer 2200 Digital Radiographic SystemImaging Dynamics Company, Ltd. · 2006
- 1 generation backK073632 Intuition, Model 0170Arcoma AB · 2008
- This deviceK140683 0180 Intuition, 0072 PrecisionArcoma AB · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042041 | Xplorer 1600 | Imaging Dynamics Company Limited | 2004 | — |
| −2 | K063039 | Xplorer 2200 Digital Radiographic System | Imaging Dynamics Company, Ltd. | 2006 | — |
| −1 | K073632 | Intuition, Model 0170 | Arcoma AB | 2008 | — |
| 0 (this device) | K140683 | 0180 Intuition, 0072 Precision | Arcoma AB | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K073632 | Intuition, Model 0170Summary page 1…al Name: Stationary digital x-ray system Regulation Number: 21 CFR 892.1680 Product Codes: KPR and MOB 3. Predicate Device: Arcoma Intuition, K073632 4. Modification Summary: (1) Newer versions of Canon digital panels will be supplied. (2) A different brand of… | 2008 |
| † | K031833 | Modification to CD Horizon Spinal System | 2003 |
| † | K031447 | Canon, Digital Radiography, Model Cxdi-50G | 2003 |
| † | K103591 | Digital Radiography | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2021 | Class II | Z-1332-2022 | Device Design | There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC). |
| May 5, 2021 | Class II | Z-1331-2022 | Device Design | There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K073632.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. The devices are not intended for mammography
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140683: 0180 Intuition, 0072 Precision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140683
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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