510(k) · Cleared
ClearedAerodr System
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 Nov 24, 2010 as substantially equivalent to K082347 (Konica Minolta Technoproduct Co., Ltd., 2008) after a 97-day review. Its family tree reaches back 5 generations to 1998. 22 later devices descend from it.
- Decided
- Nov 24, 2010
- Review
- 97 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K981556 (1998). 6 ancestors in all. 22 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 4 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 3 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 2 generations backK031633 Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc. · 2003
- 1 generation backK082347 Digital Radiography, Flexdr C30Konica Minolta Technoproduct Co., Ltd. · 2008
- This deviceK102349 Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2010
- Descendant · cites it directly · 14 of its ownK120477 Aerosync for Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2012
- Descendant · cites it directly · 14 of its ownK113248 Aerodr System with P-21Konica Minolta Medical & Graphic, Inc. · 2012
- Descendant · cites it directly · 13 of its ownK130936 Aerodr System with P-31Konica Minolta Medical & Graphic, Inc. · 2013
- Descendant · cites it directly · 12 of its ownK141271 Aerodr System 2Konica Minolta, Inc. · 2014
- Descendant · 2 generations on · 8 of its ownK162504 SKR 3000Konica Minolta, Inc. · 2016
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K120477Aerosync for Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2012 · cites it directly14descendants
- K113248Aerodr System with P-21Konica Minolta Medical & Graphic, Inc. · 2012 · cites it directly14descendants
- K130936Aerodr System with P-31Konica Minolta Medical & Graphic, Inc. · 2013 · cites it directly13descendants
- K141271Aerodr System 2Konica Minolta, Inc. · 2014 · cites it directly12descendants
- K162504SKR 3000Konica Minolta, Inc. · 2016 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −4 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −3 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −2 | K031633 | Canon Inc., Digital Radiography, Model Cxdi-40C | Canon USA, Inc. | 2003 | — |
| −1 | K082347 | Digital Radiography, Flexdr C30 | Konica Minolta Technoproduct Co., Ltd. | 2008 | — |
| 0 (this device) | K102349 | Aerodr System | Konica Minolta Medical & Graphic, Inc. | 2010 | — |
| +1 | K120477 | Aerosync for Aerodr System | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| +1 | K113248 | Aerodr System with P-21 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| +1 | K130936 | Aerodr System with P-31 | Konica Minolta Medical & Graphic, Inc. | 2013 | — |
| +1 | K141271 | Aerodr System 2 | Konica Minolta, Inc. | 2014 | — |
| +2 | K162504 | SKR 3000 | Konica Minolta, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K080318 | FDA’s K080318 is Alma Laser Nir Module Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| * | K082347 | Digital Radiography, Flexdr C30Summary page 1…assification, Product Code , Class II, 21 CFR 892.1650, 90OMQB and 21 CFR 892.2050, 90LLZ . Predicate Device Carestream DRX-1 System, KOS0318 KONICAMINOLTA, FlexDR C30, K082347 . Device Description The AeroDR SYSTEM is a digital imaging system to be used with diagnostic x-ray systems. It consists of Aer… | 2008 |
What descends from it? (22)
See all 227 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 12 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K120477 (Konica Minolta Medical & Graphic, Inc., 2012) has gone furthest, with 14 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 AeroDR SYSTEM is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.
The AeroDR SYSTEM is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102349: Aerodr System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102349
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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