510(k) · Cleared
ClearedAerodr X70
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta Medical & Graphic, Inc. · KPR System, X-Ray, Stationary
Cleared on May 23, 2012 as substantially equivalent to K073632 (Arcoma AB, 2008) after a 41-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- May 23, 2012
- Review
- 41 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- 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 deviceK121109 Aerodr X70Konica Minolta Medical & Graphic, Inc. · 2012
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) | 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 |
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…e classification Class II Predicate device The following legally marketed device to which Konica Minolta claims equivalence 1. Intuition manufactured by Arcoma AB, K073632 Device description The AeroDR X70 Is a stationary x-ray system with a ceiling mounted tube support, a floor mounted table and wa… | 2008 |
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 8 years and passes through 4 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. 2012, 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?
AeroDR X70 is a stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The AeroDR X70 is not intended for mammography
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121109: Aerodr X70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121109
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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