510(k) · Cleared
ClearedDirect Digitizer, Regius Model 190
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 15, 2004 as substantially equivalent to K023061 (Konica Minolta Medical & Graphic, Inc., 2002) after a 104-day review. Its family tree reaches back 1 generation to 2002. 5 later devices descend from it.
- Decided
- Dec 15, 2004
- Review
- 104 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023061 (2002). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK023061 Konica Direct Digitizer Regius, Model 170Konica Minolta Medical & Graphic, Inc. · 2002
- This deviceK042386 Direct Digitizer, Regius Model 190Konica Minolta Medical & Graphic, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK052095 Modification to: Direct Digitizer Regius Model 190Konica Minolta Medical & Graphic, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK071181 Direct Digitizer, Regius Model 110Konica Minolta Medical & Graphic, Inc. · 2007
- Descendant · 3 generations on · 1 of its ownK103703 Reguis SigmaKonica Minolta Medical & Graphic, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK120131 Regius SIGMA2Konica Minolta Medical & Graphic, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK092717 Direct Digitizer, Regius Model 210Konica Minolta Medical & Graphic, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K052095Modification to: Direct Digitizer Regius Model 190Konica Minolta Medical & Graphic, Inc. · 2005 · cites it directly4descendants
- K071181Direct Digitizer, Regius Model 110Konica Minolta Medical & Graphic, Inc. · 2007 · 2 generations on2descendants
- K103703Reguis SigmaKonica Minolta Medical & Graphic, Inc. · 2011 · 3 generations on1descendant
- K120131Regius SIGMA2Konica Minolta Medical & Graphic, Inc. · 2012 · 4 generations on0descendants
- K092717Direct Digitizer, Regius Model 210Konica Minolta Medical & Graphic, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023061 | Konica Direct Digitizer Regius, Model 170 | Konica Minolta Medical & Graphic, Inc. | 2002 | — |
| 0 (this device) | K042386 | Direct Digitizer, Regius Model 190 | Konica Minolta Medical & Graphic, Inc. | 2004 | — |
| +1 | K052095 | Modification to: Direct Digitizer Regius Model 190 | Konica Minolta Medical & Graphic, Inc. | 2005 | — |
| +2 | K071181 | Direct Digitizer, Regius Model 110 | Konica Minolta Medical & Graphic, Inc. | 2007 | — |
| +3 | K103703 | Reguis Sigma | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
| +4 | K120131 | Regius SIGMA2 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| +2 | K092717 | Direct Digitizer, Regius Model 210 | Konica Minolta Medical & Graphic, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K023061 | Konica Direct Digitizer Regius, Model 170Summary page 1…21 CFR 892. 1650. 7. Predicate Device The Direct Digitizer, REGIUS MODEL 190 is substantially equivalent to our Konica Direct Digitizer REGIUS MODEL170, 510(k) number: K023061. Comparison of the principal characteristics of the two devices is shown in the Appendix 1 Cross-reference table. === Page 2 ==… | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052095 | Modification to: Direct Digitizer Regius Model 190 | 2005 | 4 |
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?
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.
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 Direct Digitizer, REGIUS Model 190 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities. This device is not intended for use with digital mammography system.
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/K042386 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042386: Direct Digitizer, Regius Model 190.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042386
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