510(k) · Cleared
Recalled · 2006Direct Digitizer Regius Model 370
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 Jul 1, 2005 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 24 later devices descend from it. It has been recalled once.
- Decided
- Jul 1, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 0
24 later devices descend from it, 1 citing it directly.
- This deviceK051418 Direct Digitizer Regius Model 370Konica Minolta Medical & Graphic, Inc. · 2005
- Descendant · cites it directly · 23 of its ownK082347 Digital Radiography, Flexdr C30Konica Minolta Technoproduct Co., Ltd. · 2008
- Descendant · 2 generations on · 22 of its ownK102349 Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2010
- Descendant · 3 generations on · 14 of its ownK120477 Aerosync for Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2012
- Descendant · 3 generations on · 14 of its ownK113248 Aerodr System with P-21Konica Minolta Medical & Graphic, Inc. · 2012
- Descendant · 3 generations on · 13 of its ownK130936 Aerodr System with P-31Konica Minolta Medical & Graphic, Inc. · 2013
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K082347Digital Radiography, Flexdr C30Konica Minolta Technoproduct Co., Ltd. · 2008 · cites it directly23descendants
- K102349Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2010 · 2 generations on22descendants
- K120477Aerosync for Aerodr SystemKonica Minolta Medical & Graphic, Inc. · 2012 · 3 generations on14descendants
- K113248Aerodr System with P-21Konica Minolta Medical & Graphic, Inc. · 2012 · 3 generations on14descendants
- K130936Aerodr System with P-31Konica Minolta Medical & Graphic, Inc. · 2013 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051418 | Direct Digitizer Regius Model 370 | Konica Minolta Medical & Graphic, Inc. | 2005 | — |
| +1 | K082347 | Digital Radiography, Flexdr C30 | Konica Minolta Technoproduct Co., Ltd. | 2008 | — |
| +2 | K102349 | Aerodr System | Konica Minolta Medical & Graphic, Inc. | 2010 | — |
| +3 | K120477 | Aerosync for Aerodr System | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| +3 | K113248 | Aerodr System with P-21 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| +3 | K130936 | Aerodr System with P-31 | Konica Minolta Medical & Graphic, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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 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? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082347 | Digital Radiography, Flexdr C30 | 2008 | 23 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2006 | Not classified | Z-1481-06 | Other | A hand grip column, even though locked in position, moved downward about 3 cm while a patient was holding the hand grip for lateral exposure. When the hand grip moved down, the patient who was holding it lost his or her balance and almost… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082347 (Konica Minolta Technoproduct Co., Ltd., 2008) has gone furthest, with 23 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 Direct Digitizer, REGIUS MODEL 370 is an X-ray image controller which uses a Simulative phosphor as X-ray detector and intended to control and manages digital X-ray image file processing. The REGIUS MODEL 370 is NOT intended for use with digital mammography system.
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/K051418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051418: Direct Digitizer Regius Model 370.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051418
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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