510(k) · Cleared
ClearedReguis Sigma
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 Jun 2, 2011 as substantially equivalent to K071181 (Konica Minolta Medical & Graphic, Inc., 2007) and 1 other predicate after a 164-day review. Its family tree reaches back 4 generations to 2002. 1 later device descends from it.
- Decided
- Jun 2, 2011
- Review
- 164 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K023061 (2002). 7 ancestors in all, the oldest K913844 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK023061 Konica Direct Digitizer Regius, Model 170Konica Minolta Medical & Graphic, Inc. · 2002
- 3 generations backK042386 Direct Digitizer, Regius Model 190Konica Minolta Medical & Graphic, Inc. · 2004
- 2 generations backK052095 Modification to: Direct Digitizer Regius Model 190Konica Minolta Medical & Graphic, Inc. · 2005
- 1 generation backK071181 Direct Digitizer, Regius Model 110Konica Minolta Medical & Graphic, Inc. · 2007
- This deviceK103703 Reguis SigmaKonica Minolta Medical & Graphic, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK120131 Regius SIGMA2Konica Minolta Medical & Graphic, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120131Regius SIGMA2Konica Minolta Medical & Graphic, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K023061 | Konica Direct Digitizer Regius, Model 170 | Konica Minolta Medical & Graphic, Inc. | 2002 | — |
| −3 | 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 | — |
| −1 | K071181 | Direct Digitizer, Regius Model 110 | Konica Minolta Medical & Graphic, Inc. | 2007 | — |
| 0 (this device) | K103703 | Reguis Sigma | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
| +1 | K120131 | Regius SIGMA2 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K071181 | Direct Digitizer, Regius Model 110Summary page 1…ame Direct Digitizer, REGIUS SIGMA 5. Classification Class HI, 90 MOB, 21 CFR 892.1630. 6. Predicate Device Direct Digitizer, REGIUS Model 110, 510(k) number: K071181 Point-of-Care CR360, 510O(k) number: K073630 7. Indications for Use The Direct Digitizer, REGIUS SIGMA is an X-ray image rea… | 2007 |
| * | K073630 | Modification to: Bpcard, Model Z-7000-0700Summary page 1…fication Class HI, 90 MOB, 21 CFR 892.1630. 6. Predicate Device Direct Digitizer, REGIUS Model 110, 510(k) number: K071181 Point-of-Care CR360, 510O(k) number: K073630 7. Indications for Use The Direct Digitizer, REGIUS SIGMA is an X-ray image reader which uses a. stimulable phosphor plate (Pl… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120131 | Regius SIGMA2 | 2012 | 0 |
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 9 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K120131 (Konica Minolta Medical & Graphic, Inc., 2012) has gone furthest, with 0 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. 2011, 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 SIGMA 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 in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103703: Reguis Sigma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103703
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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