510(k) · Cleared
ClearedSignet Dxis Direct X-Ray Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signet Radiology, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Nov 6, 1998 as substantially equivalent to K961826 (Trophy Radiologie, 1996) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 1996. 36 later devices descend from it.
- Decided
- Nov 6, 1998
- Review
- 49 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961826 (1996). 2 ancestors in all. 36 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK961826 DigipanTrophy Radiologie · 1996
- This deviceK983283 Signet Dxis Direct X-Ray Imaging SystemSignet Radiology, Inc. · 1998
- Descendant · cites it directly · 32 of its ownK041120 EV Apan Digital, Model K1VSM2000Afp Imaging Corp. · 2004
- Descendant · 2 generations on · 30 of its ownK090749 Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Villa Sistemi Medicali S.P.A. · 2009
- Descendant · 3 generations on · 27 of its ownK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- Descendant · 4 generations on · 24 of its ownK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · 5 generations on · 23 of its ownK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K041120EV Apan Digital, Model K1VSM2000Afp Imaging Corp. · 2004 · cites it directly32descendants
- K090749Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Villa Sistemi Medicali S.P.A. · 2009 · 2 generations on30descendants
- K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · 3 generations on27descendants
- K122981Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 4 generations on24descendants
- K131695Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 5 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961826 | Digipan | Trophy Radiologie | 1996 | — |
| 0 (this device) | K983283 | Signet Dxis Direct X-Ray Imaging System | Signet Radiology, Inc. | 1998 | — |
| +1 | K041120 | EV Apan Digital, Model K1VSM2000 | Afp Imaging Corp. | 2004 | — |
| +2 | K090749 | Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191 | Villa Sistemi Medicali S.P.A. | 2009 | — |
| +3 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| +4 | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +5 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K961826 | DigipanSummary page 1…S® Direct X-ray Imaging System Common/Usual Name: Digital x-ray imaging system Classification Name: Extra-oral source x-ray system 3. PREDICATE DEVICES Trophy Digipan (K961826) Siemens Orthophos DS (K972312) Planmeca Dimax (510(k) # not known) 4. DEVICE DESCRIPTION The Signet DXIS® is intended for dent… | 1996 |
| * | K972312 | Siemens Orthophos DS/DS CephSummary page 1…Common/Usual Name: Digital x-ray imaging system Classification Name: Extra-oral source x-ray system 3. PREDICATE DEVICES Trophy Digipan (K961826) Siemens Orthophos DS (K972312) Planmeca Dimax (510(k) # not known) 4. DEVICE DESCRIPTION The Signet DXIS® is intended for dental radiographic examination and… | 1997 |
| * | — | Planmeca Dimax Named without a submission number |
What descends from it? (36)
See all 363 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?
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
THE DXIS® IS INTENDED FOR DENTAL RADIOGRAPHIC EXAMINATION AND DIOGNOSIS OF DISEASES OF THE TEETH, JAW AND ORAL STRUCTURE.
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/K983283 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983283: Signet Dxis Direct X-Ray Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983283
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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