510(k) · Cleared
ClearedKonica Direct Digitizer Regius, Model 170
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 Oct 11, 2002 after a 25-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Oct 11, 2002
- Review
- 25 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK023061 Konica Direct Digitizer Regius, Model 170Konica Minolta Medical & Graphic, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK042386 Direct Digitizer, Regius Model 190Konica Minolta Medical & Graphic, Inc. · 2004
- Descendant · 2 generations on · 4 of its ownK052095 Modification to: Direct Digitizer Regius Model 190Konica Minolta Medical & Graphic, Inc. · 2005
- Descendant · 3 generations on · 2 of its ownK071181 Direct Digitizer, Regius Model 110Konica Minolta Medical & Graphic, Inc. · 2007
- Descendant · 4 generations on · 1 of its ownK103703 Reguis SigmaKonica Minolta Medical & Graphic, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK051998 Regius Model 170 Direct DigitizerKonica Minolta Medical & Graphic, Inc. · 2005
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K042386Direct Digitizer, Regius Model 190Konica Minolta Medical & Graphic, Inc. · 2004 · cites it directly5descendants
- K052095Modification to: Direct Digitizer Regius Model 190Konica Minolta Medical & Graphic, Inc. · 2005 · 2 generations on4descendants
- K071181Direct Digitizer, Regius Model 110Konica Minolta Medical & Graphic, Inc. · 2007 · 3 generations on2descendants
- K103703Reguis SigmaKonica Minolta Medical & Graphic, Inc. · 2011 · 4 generations on1descendant
- K051998Regius Model 170 Direct DigitizerKonica Minolta Medical & Graphic, Inc. · 2005 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023061 | Konica Direct Digitizer Regius, Model 170 | Konica Minolta Medical & Graphic, Inc. | 2002 | — |
| +1 | K042386 | Direct Digitizer, Regius Model 190 | Konica Minolta Medical & Graphic, Inc. | 2004 | — |
| +2 | K052095 | Modification to: Direct Digitizer Regius Model 190 | Konica Minolta Medical & Graphic, Inc. | 2005 | — |
| +3 | K071181 | Direct Digitizer, Regius Model 110 | Konica Minolta Medical & Graphic, Inc. | 2007 | — |
| +4 | K103703 | Reguis Sigma | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
| +1 | K051998 | Regius Model 170 Direct Digitizer | Konica Minolta Medical & Graphic, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
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?
- Of its descendants, K042386 (Konica Minolta Medical & Graphic, Inc., 2004) has gone furthest, with 5 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.
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 Konica Direct Digitizer Model 170 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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K023061 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023061: Konica Direct Digitizer Regius, Model 170.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023061
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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