510(k) · Cleared
ClearedAeropilot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta Medical & Graphic, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Dec 20, 2012 as substantially equivalent to K102349 (Konica Minolta Medical & Graphic, Inc., 2010) and 2 other predicates after a 37-day review. Its family tree reaches back 7 generations to 1998.
- Decided
- Dec 20, 2012
- Review
- 37 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K981556 (1998). 9 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK123499 AeropilotKonica Minolta Medical & Graphic, Inc. · 2012
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) | K123499 | Aeropilot | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 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 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? (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 |
|---|---|---|---|
| * | K102349 | Aerodr SystemSummary page 1…oPilot 5. Common Name Picture Archiving Communications System 6. Classification, Product Code Class U1,9OLLZ 7. Predicate Device AeroDR SYSTEM, 510O(k) number K1 02349 AeroSync for AeroOR SYSTEM, 510O(k) number K1 02349 AeroOR SYSTEM with P-21, 510(k) number K113248 (Konica Minolta Digital… | 2010 |
| * | K120477 | Aerosync for Aerodr SystemSummary page 2…are, Appendix 13-G 11. Substantial Equivalence to Predicate Device The predicate devices of AeroPilot is our Konica Minolta Digital Radiography systems (K1 02349, K1 20477; K1 13248). A comparison of the Indications for Use, Configuration, Specifications, and Principal of Operation of this pro… | 2012 |
| * | K113248 | Aerodr System with P-21Summary page 1…ass U1,9OLLZ 7. Predicate Device AeroDR SYSTEM, 510O(k) number K1 02349 AeroSync for AeroOR SYSTEM, 510O(k) number K1 02349 AeroOR SYSTEM with P-21, 510(k) number K113248 (Konica Minolta Digital Radiography system) 8. Indications for Use AeroPilot is a software device that is used in conjuncti… | 2012 |
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 14 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 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. 2012, 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?
AeroPilot is a software device that is used in conjunction with REGIUS Unitea to control Konica Minolta Digital Radiography systems. This device 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. This device 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/K123499 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123499: Aeropilot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123499
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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