510(k) · Cleared
ClearedEV Apan Digital, Model K1VSM2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Afp Imaging Corp. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Aug 30, 2004 as substantially equivalent to K961826 (Trophy Radiologie, 1996) and 3 other predicates after a 123-day review. Its family tree reaches back 2 generations to 1996. 32 later devices descend from it.
- Decided
- Aug 30, 2004
- Review
- 123 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K961826 (1996). 5 ancestors in all. 32 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK961826 DigipanTrophy Radiologie · 1996
- 1 generation backK983283 Signet Dxis Direct X-Ray Imaging SystemSignet Radiology, Inc. · 1998
- This deviceK041120 EV Apan Digital, Model K1VSM2000Afp Imaging Corp. · 2004
- Descendant · cites it directly · 30 of its ownK090749 Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Villa Sistemi Medicali S.P.A. · 2009
- Descendant · 2 generations on · 27 of its ownK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- Descendant · 3 generations on · 24 of its ownK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · 4 generations on · 23 of its ownK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · 4 generations on · 22 of its ownK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K090749Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Villa Sistemi Medicali S.P.A. · 2009 · cites it directly30descendants
- K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · 2 generations on27descendants
- K122981Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 3 generations on24descendants
- K131695Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 4 generations on23descendants
- K142247Rayscan a-Expert 3DRay Co., Ltd. · 2015 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961826 | Digipan | Trophy Radiologie | 1996 | — |
| −1 | K983283 | Signet Dxis Direct X-Ray Imaging System | Signet Radiology, Inc. | 1998 | — |
| 0 (this device) | K041120 | EV Apan Digital, Model K1VSM2000 | Afp Imaging Corp. | 2004 | — |
| +1 | K090749 | Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191 | Villa Sistemi Medicali S.P.A. | 2009 | — |
| +2 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| +3 | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +4 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +4 | K142247 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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? (4)
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 2…quivalent to the several other Digital Panoramic systems currently legally marketed in United States. The equivalent systems examined are the Trophy DigiPan (K961826, K991912, K012514) and the Signet Radiology DXIS (K983283). The K lVSM2000 System and the predicate devices listed, t… | 1996 |
| * | K991912 | Modification to DigipanSummary page 2…e several other Digital Panoramic systems currently legally marketed in United States. The equivalent systems examined are the Trophy DigiPan (K961826, K991912, K012514) and the Signet Radiology DXIS (K983283). The K lVSM2000 System and the predicate devices listed, the Trophy DigiP… | 1999 |
| * | K012514 | Digipan / DpiSummary page 2…everal other Digital Panoramic systems currently legally marketed in United States. The equivalent systems examined are the Trophy DigiPan (K961826, K991912, K012514) and the Signet Radiology DXIS (K983283). The K lVSM2000 System and the predicate devices listed, the Trophy DigiPan and th… | 2001 |
| * | K983283 | Signet Dxis Direct X-Ray Imaging SystemSummary page 2…urrently legally marketed in United States. The equivalent systems examined are the Trophy DigiPan (K961826, K991912, K012514) and the Signet Radiology DXIS (K983283). The K lVSM2000 System and the predicate devices listed, the Trophy DigiPan and the Signet DXIS, have the same inten… | 1998 |
What descends from it? (32)
See all 322 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090749 (Villa Sistemi Medicali S.P.A., 2009) has gone furthest, with 30 descendants of its own.
- 1 other device also cites its predicate K961826.
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 EVApan Digital / K1VSM2000 Dental Panoramic Sensor is intended to be used with the STRATO Panoramic X-ray System (K00243-2), manufactured by VILLA SISTEMI MEDICALI S.P.A (registration number 8021091) and a computer work station station for Dental Panoramic Radiographic Imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041120 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041120: EV Apan Digital, Model K1VSM2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041120
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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