510(k) · Cleared
ClearedDirect Digitizer, Regius Model 110
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 May 30, 2007 as substantially equivalent to K052095 (Konica Minolta Medical & Graphic, Inc., 2005) after a 30-day review. Its family tree reaches back 3 generations to 2002. 2 later devices descend from it.
- Decided
- May 30, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K023061 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK023061 Konica Direct Digitizer Regius, Model 170Konica Minolta Medical & Graphic, Inc. · 2002
- 2 generations backK042386 Direct Digitizer, Regius Model 190Konica Minolta Medical & Graphic, Inc. · 2004
- 1 generation backK052095 Modification to: Direct Digitizer Regius Model 190Konica Minolta Medical & Graphic, Inc. · 2005
- This deviceK071181 Direct Digitizer, Regius Model 110Konica Minolta Medical & Graphic, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK103703 Reguis SigmaKonica Minolta Medical & Graphic, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK120131 Regius SIGMA2Konica Minolta Medical & Graphic, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K023061 | Konica Direct Digitizer Regius, Model 170 | Konica Minolta Medical & Graphic, Inc. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K071181 | Direct Digitizer, Regius Model 110 | Konica Minolta Medical & Graphic, Inc. | 2007 | — |
| +1 | K103703 | Reguis Sigma | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
| +2 | K120131 | Regius SIGMA2 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K052095 | Modification to: Direct Digitizer Regius Model 190Summary page 1…mon Name Computed Radiography Image Reader 7. Classification Class II, 90 MQB, 21 CFR 892. 1630. 8. Predicate Device Direct Digitizer, REGIUS Model 190, 510(k) number: K052095 9. Description of Device The Direct Digitizer, REGIUS Model 110 is an X-ray image reader which uses a stimulable phosphor plate… | 2005 |
| † | K090359 | Model DD341 / REGIUS150 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103703 | Reguis Sigma | 2011 | 1 |
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 5 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103703 (Konica Minolta Medical & Graphic, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K052095.
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. 2007, 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 Direct Digitizer, REGIUS Model 110 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. REGIUS Model 110 also reads the image…
Read the full statement (128 words)
The Direct Digitizer, REGIUS Model 110 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. REGIUS Model 110 also reads the image data of long areas of anatomy and to verify the position for a radiotherapy location. 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/K071181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071181: Direct Digitizer, Regius Model 110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071181
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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