510(k) · Cleared
ClearedSKR 3000
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 Nov 17, 2022 as substantially equivalent to K213908 (Konica Minolta, Inc., 2022) after a 24-day review. Its family tree reaches back 13 generations to 1998.
- Decided
- Nov 17, 2022
- Review
- 24 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K981556 (1998). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 9 generations between
- 3 generations backK182688 SKR 3000Konica Minolta, Inc. · 2018
- 2 generations backK210619 SKR 3000Konica Minolta, Inc. · 2021
- 1 generation backK213908 SKR 3000Konica Minolta, Inc. · 2022
- This deviceK223267 SKR 3000Konica Minolta, Inc. · 2022
Show all 13 generations
- Root · 13 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 12 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 11 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 10 generations backK031633 Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc. · 2003
- 9 generations backK082347 Digital Radiography, Flexdr C30Konica Minolta Technoproduct Co., Ltd. · 2008
- 8 generations backK102349 Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2010
- 7 generations backK113248 Aerodr System with P-21Konica Minolta Medical & Graphic, Inc. · 2012
- 6 generations backK141271 Aerodr System 2Konica Minolta, Inc. · 2014
- 5 generations backK162504 SKR 3000Konica Minolta, Inc. · 2016
- 4 generations backK172793 SKR 3000Konica Minolta, Inc. · 2017
- 3 generations backK182688 SKR 3000Konica Minolta, Inc. · 2018
- 2 generations backK210619 SKR 3000Konica Minolta, Inc. · 2021
- 1 generation backK213908 SKR 3000Konica Minolta, Inc. · 2022
- This deviceK223267 SKR 3000Konica Minolta, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −12 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −11 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −10 | K031633 | Canon Inc., Digital Radiography, Model Cxdi-40C | Canon USA, Inc. | 2003 | — |
| −9 | K082347 | Digital Radiography, Flexdr C30 | Konica Minolta Technoproduct Co., Ltd. | 2008 | — |
| −8 | K102349 | Aerodr System | Konica Minolta Medical & Graphic, Inc. | 2010 | — |
| −7 | K113248 | Aerodr System with P-21 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| −6 | K141271 | Aerodr System 2 | Konica Minolta, Inc. | 2014 | — |
| −5 | K162504 | SKR 3000 | Konica Minolta, Inc. | 2016 | — |
| −4 | K172793 | SKR 3000 | Konica Minolta, Inc. | 2017 | — |
| −3 | K182688 | SKR 3000 | Konica Minolta, Inc. | 2018 | — |
| −2 | K210619 | SKR 3000 | Konica Minolta, Inc. | 2021 | — |
| −1 | K213908 | SKR 3000 | Konica Minolta, Inc. | 2022 | — |
| 0 (this device) | K223267 | SKR 3000 | Konica Minolta, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K213908 | SKR 3000Summary page 4…aphy Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code(s): MQB, LLZ Predicate Device: K213908 - SKR 3000 (KONICA MINOLTA, INC.) Regulation Number: 21 CFR 892.1680 Regulation Name: S… | 2022 |
| † | K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | 2022 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 16 ancestors has a recall of any class.
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. 2022, 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 SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpose diagnostic procedures.
The SKR 3000 is not indicated for use in mammography, fluoroscopy and angiography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223267 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223267: SKR 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223267
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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