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 Dec 18, 2018 as substantially equivalent to K172793 (Konica Minolta, Inc., 2017) after an 83-day review. Its family tree reaches back 10 generations to 1998. 4 later devices descend from it.
- Decided
- Dec 18, 2018
- Review
- 83 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K981556 (1998). 13 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations between
- 3 generations backK141271 Aerodr System 2Konica Minolta, Inc. · 2014
- 2 generations backK162504 SKR 3000Konica Minolta, Inc. · 2016
- 1 generation backK172793 SKR 3000Konica Minolta, Inc. · 2017
- This deviceK182688 SKR 3000Konica Minolta, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK210619 SKR 3000Konica Minolta, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK213908 SKR 3000Konica Minolta, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK223267 SKR 3000Konica Minolta, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK191645 SKR 4000Konica Minolta, Inc. · 2019
Show all 10 generations
- Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 9 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 8 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 7 generations backK031633 Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc. · 2003
- 6 generations backK082347 Digital Radiography, Flexdr C30Konica Minolta Technoproduct Co., Ltd. · 2008
- 5 generations backK102349 Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2010
- 4 generations backK113248 Aerodr System with P-21Konica Minolta Medical & Graphic, Inc. · 2012
- 3 generations backK141271 Aerodr System 2Konica Minolta, Inc. · 2014
- 2 generations backK162504 SKR 3000Konica Minolta, Inc. · 2016
- 1 generation backK172793 SKR 3000Konica Minolta, Inc. · 2017
- This deviceK182688 SKR 3000Konica Minolta, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −9 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −8 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −7 | K031633 | Canon Inc., Digital Radiography, Model Cxdi-40C | Canon USA, Inc. | 2003 | — |
| −6 | K082347 | Digital Radiography, Flexdr C30 | Konica Minolta Technoproduct Co., Ltd. | 2008 | — |
| −5 | K102349 | Aerodr System | Konica Minolta Medical & Graphic, Inc. | 2010 | — |
| −4 | K113248 | Aerodr System with P-21 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| −3 | K141271 | Aerodr System 2 | Konica Minolta, Inc. | 2014 | — |
| −2 | K162504 | SKR 3000 | Konica Minolta, Inc. | 2016 | — |
| −1 | K172793 | SKR 3000 | Konica Minolta, Inc. | 2017 | — |
| 0 (this device) | K182688 | SKR 3000 | Konica Minolta, Inc. | 2018 | — |
| +1 | K210619 | SKR 3000 | Konica Minolta, Inc. | 2021 | — |
| +2 | K213908 | SKR 3000 | Konica Minolta, Inc. | 2022 | — |
| +3 | K223267 | SKR 3000 | Konica Minolta, Inc. | 2022 | — |
| +1 | K191645 | SKR 4000 | Konica Minolta, Inc. | 2019 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K172793 | SKR 3000Summary page 4…n Name / Number: Stationary x-ray system / 21 CFR 892.1680 Regulatory Class: Class II Product Code(s): 90-MQB, 90-LLZ Predicate Device(s): K172793 - SKR 3000 (KONICA MINOLTA, INC.) Regulation Name: Stationary x-ray system (21CFR 892.1680)… | 2017 |
What descends from it? (4)
2 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 20 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K210619 (Konica Minolta, Inc., 2021) has gone furthest, with 2 descendants of its own.
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. 2018, 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 a 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/K182688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182688: SKR 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182688
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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