510(k) · Cleared
ClearedDigital Radiography, Flexdr C30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta Technoproduct Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 18, 2008 as substantially equivalent to K051418 (Konica Minolta Medical & Graphic, Inc., 2005) and 1 other predicate after a 95-day review. Its family tree reaches back 4 generations to 1998. 23 later devices descend from it.
- Decided
- Nov 18, 2008
- Review
- 95 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981556 (1998). 5 ancestors in all. 23 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 3 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 2 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 1 generation backK031633 Canon Inc., Digital Radiography, Model Cxdi-40CCanon USA, Inc. · 2003
- This deviceK082347 Digital Radiography, Flexdr C30Konica Minolta Technoproduct Co., Ltd. · 2008
- Descendant · cites it directly · 22 of its ownK102349 Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2010
- Descendant · 2 generations on · 14 of its ownK120477 Aerosync for Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2012
- Descendant · 2 generations on · 14 of its ownK113248 Aerodr System with P-21Konica Minolta Medical & Graphic, Inc. · 2012
- Descendant · 2 generations on · 13 of its ownK130936 Aerodr System with P-31Konica Minolta Medical & Graphic, Inc. · 2013
- Descendant · 2 generations on · 12 of its ownK141271 Aerodr System 2Konica Minolta, Inc. · 2014
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K102349Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2010 · cites it directly22descendants
- K120477Aerosync for Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2012 · 2 generations on14descendants
- K113248Aerodr System with P-21Konica Minolta Medical & Graphic, Inc. · 2012 · 2 generations on14descendants
- K130936Aerodr System with P-31Konica Minolta Medical & Graphic, Inc. · 2013 · 2 generations on13descendants
- K141271Aerodr System 2Konica Minolta, Inc. · 2014 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −3 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −2 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −1 | K031633 | Canon Inc., Digital Radiography, Model Cxdi-40C | Canon USA, Inc. | 2003 | — |
| 0 (this device) | K082347 | Digital Radiography, Flexdr C30 | Konica Minolta Technoproduct Co., Ltd. | 2008 | — |
| +1 | K102349 | Aerodr System | Konica Minolta Medical & Graphic, Inc. | 2010 | — |
| +2 | K120477 | Aerosync for Aerodr System | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| +2 | K113248 | Aerodr System with P-21 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| +2 | K130936 | Aerodr System with P-31 | Konica Minolta Medical & Graphic, Inc. | 2013 | — |
| +2 | K141271 | Aerodr System 2 | Konica Minolta, Inc. | 2014 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051418 | Direct Digitizer Regius Model 370Summary page 1…Digital Imager) 6. Classification Class II, 21 CFR 892. 1630, Solid State X-ray Imager 7. Product Code 90 MQB 8. Predicate Device Direct Digitizer, Regius Model 370, K051418 Canon Inc, Digital Radiography Mode! CXDI-40C, K031633 3-1 9. Description of Device FlexDR C30 is comprised of… | 2005 |
| * | K031633 | Canon Inc., Digital Radiography, Model Cxdi-40CSummary page 1…. 1630, Solid State X-ray Imager 7. Product Code 90 MQB 8. Predicate Device Direct Digitizer, Regius Model 370, K051418 Canon Inc, Digital Radiography Mode! CXDI-40C, K031633 3-1 9. Description of Device FlexDR C30 is comprised of a reader and an elevator stand that raises and lowers t… | 2003 |
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102349 | Aerodr System | 2010 | 22 |
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 10 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K102349 (Konica Minolta Medical & Graphic, Inc., 2010) has gone furthest, with 22 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. 2008, 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 device is intended for use for medical purpose in a hospital, etc., in order to convert X-ray image data to digital signal and to transfer the converted data to printer, filing system, image display device, etc.
Flex DR C30 is not intended for use with FFDM systems.
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/K082347 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082347: Digital Radiography, Flexdr C30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082347
Report an extraction error
Are you the manufacturer?
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