510(k) · Cleared
ClearedAerodr System 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Sep 26, 2014 as substantially equivalent to K102349 (Konica Minolta Medical & Graphic, Inc., 2010) and 3 other predicates after a 134-day review. Its family tree reaches back 7 generations to 1998. 12 later devices descend from it.
- Decided
- Sep 26, 2014
- Review
- 134 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K981556 (1998). 10 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 5 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 4 generations backK031633 Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc. · 2003
- 3 generations backK082347 Digital Radiography, Flexdr C30Konica Minolta Technoproduct Co., Ltd. · 2008
- 2 generations backK102349 Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2010
- 1 generation backK113248 Aerodr System with P-21Konica Minolta Medical & Graphic, Inc. · 2012
- This deviceK141271 Aerodr System 2Konica Minolta, Inc. · 2014
- Descendant · cites it directly · 8 of its ownK162504 SKR 3000Konica Minolta, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK172793 SKR 3000Konica Minolta, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK182688 SKR 3000Konica Minolta, Inc. · 2018
- Descendant · 4 generations on · 2 of its ownK210619 SKR 3000Konica Minolta, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK151465 AeroDR SYSTEM 2Konica Minolta, Inc. · 2015 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K162504SKR 3000Konica Minolta, Inc. · 2016 · cites it directly8descendants
- K172793SKR 3000Konica Minolta, Inc. · 2017 · 2 generations on5descendants
- K182688SKR 3000Konica Minolta, Inc. · 2018 · 3 generations on4descendants
- K210619SKR 3000Konica Minolta, Inc. · 2021 · 4 generations on2descendants
- K151465AeroDR SYSTEM 2Konica Minolta, Inc. · 2015 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −6 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −5 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −4 | K031633 | Canon Inc., Digital Radiography, Model Cxdi-40C | Canon USA, Inc. | 2003 | — |
| −3 | K082347 | Digital Radiography, Flexdr C30 | Konica Minolta Technoproduct Co., Ltd. | 2008 | — |
| −2 | K102349 | Aerodr System | Konica Minolta Medical & Graphic, Inc. | 2010 | — |
| −1 | K113248 | Aerodr System with P-21 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| 0 (this device) | K141271 | Aerodr System 2 | Konica Minolta, Inc. | 2014 | — |
| +1 | K162504 | SKR 3000 | Konica Minolta, Inc. | 2016 | — |
| +2 | K172793 | SKR 3000 | Konica Minolta, Inc. | 2017 | — |
| +3 | K182688 | SKR 3000 | Konica Minolta, Inc. | 2018 | — |
| +4 | K210619 | SKR 3000 | Konica Minolta, Inc. | 2021 | — |
| +1 | K151465 | AeroDR SYSTEM 2 | Konica Minolta, Inc. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K102349 | Aerodr SystemSummary page 4…Picture archiving and communications system) 8. Corresponding regulation 21CFR 892.1680: Stationary x-ray system 9. Predicate Device AeroDR SYSTEMS 510(k) number K102349, K113248, K120477, K130936 10. Description of Device The AeroDR SYSTEM 2 is a digital imaging system to be used… | 2010 |
| * | K113248 | Aerodr System with P-21Summary page 4…rchiving and communications system) 8. Corresponding regulation 21CFR 892.1680: Stationary x-ray system 9. Predicate Device AeroDR SYSTEMS 510(k) number K102349, K113248, K120477, K130936 10. Description of Device The AeroDR SYSTEM 2 is a digital imaging system to be used with dia… | 2012 |
| * | K120477 | Aerosync for Aerodr SystemSummary page 4…and communications system) 8. Corresponding regulation 21CFR 892.1680: Stationary x-ray system 9. Predicate Device AeroDR SYSTEMS 510(k) number K102349, K113248, K120477, K130936 10. Description of Device The AeroDR SYSTEM 2 is a digital imaging system to be used with diagnostic… | 2012 |
| * | K130936 | Aerodr System with P-31Summary page 4…nications system) 8. Corresponding regulation 21CFR 892.1680: Stationary x-ray system 9. Predicate Device AeroDR SYSTEMS 510(k) number K102349, K113248, K120477, K130936 10. Description of Device The AeroDR SYSTEM 2 is a digital imaging system to be used with diagnostic x-ray sy… | 2013 |
What descends from it? (12)
See all 123 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 16 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K162504 (Konica Minolta, Inc., 2016) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K102349.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
The AeroDR SYSTEM 2 is indicated for use in generating radiographic images of human anatomy. It is intended to
replace radiographic film/screen system in general-purpse diagnostic procedures.
The AeroDR SYSTEM 2 is not indicated for use in mammography, fluoroscopy, tomography and angiography
applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141271 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141271: Aerodr System 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141271
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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