510(k) · Cleared
ClearedIntuition, Model 0170
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 Jan 10, 2008 as substantially equivalent to K011486 (Quantum Medical Imaging, LLC, 2001) and 2 other predicates after a 15-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Jan 10, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K042041 (2004). 4 ancestors in all, the oldest K011486 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK042041 Xplorer 1600Imaging Dynamics Company Limited · 2004
- 1 generation backK063039 Xplorer 2200 Digital Radiographic SystemImaging Dynamics Company, Ltd. · 2006
- This deviceK073632 Intuition, Model 0170Arcoma AB · 2008
- Descendant · cites it directly · 0 of its ownK140683 0180 Intuition, 0072 PrecisionArcoma AB · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK121109 Aerodr X70Konica Minolta Medical & Graphic, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042041 | Xplorer 1600 | Imaging Dynamics Company Limited | 2004 | — |
| −1 | K063039 | Xplorer 2200 Digital Radiographic System | Imaging Dynamics Company, Ltd. | 2006 | — |
| 0 (this device) | K073632 | Intuition, Model 0170 | Arcoma AB | 2008 | — |
| +1 | K140683 | 0180 Intuition, 0072 Precision | Arcoma AB | 2014 | 2 |
| +1 | K121109 | Aerodr X70 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K011486 | Q-Rad Radiographic SystemSummary page 1…Number 892.1680 Device classification Class II Predicate device 1. Q-Rad Radiographic System manufactured by Quantum Medical Imaging LLC, K011486 2. Xplorer 2200 Digital Radiographic System manufactured by Imaging Dynamics Company Ltd, K063039 3. DAR7000 RADspeed… | 2001 |
| * | K063039 | Xplorer 2200 Digital Radiographic SystemSummary page 1…phic System manufactured by Quantum Medical Imaging LLC, K011486 2. Xplorer 2200 Digital Radiographic System manufactured by Imaging Dynamics Company Ltd, K063039 3. DAR7000 RADspeed SAFIRE manufactured by Shimadzu Corporation, K(050925 Device description The 01 70 Intuition is a s… | 2006 |
| * | K050925 | Digital Radiography System Radspeed SafireSummary page 1…2200 Digital Radiographic System manufactured by Imaging Dynamics Company Ltd, K063039 3. DAR7000 RADspeed SAFIRE manufactured by Shimadzu Corporation, K(050925 Device description The 01 70 Intuition is a stationary x-ray system with a ceiling mounted tube stand, a floor mounted table and… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K140683 (Arcoma AB, 2014) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K011486.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 0170 Intuition is a stationery x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment.
The 0170 Intuition is not intended for mammography
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073632: Intuition, Model 0170.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073632
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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