510(k) · Cleared
ClearedPanoura 18S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Yoshida Dental Mfg. Co., Ltd. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Jul 13, 2011 as substantially equivalent to K093683 (Instrumentarium Dental, Palodex Group OY, 2010) after a 72-day review. Its family tree reaches back 6 generations to 1997. 11 later devices descend from it.
- Decided
- Jul 13, 2011
- Review
- 72 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K973598 (1997). 14 ancestors in all, the oldest K930338 (1993). 11 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 4 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 3 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 2 generations backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 1 generation backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- This deviceK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- Descendant · cites it directly · 6 of its ownK122199 PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK161881 PreXion3D ExcelsiorPrexion Corporation · 2016
- Descendant · 2 generations on · 2 of its ownK152489 ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 2016
- Descendant · cites it directly · 2 of its ownK122806 Image Works PanouraMic International · 2013
- Descendant · 3 generations on · 1 of its ownK210820 EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013 · cites it directly6descendants
- K161881PreXion3D ExcelsiorPrexion Corporation · 2016 · 2 generations on2descendants
- K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 2016 · 2 generations on2descendants
- K122806Image Works PanouraMic International · 2013 · cites it directly2descendants
- K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −5 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −4 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −3 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −2 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −1 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| 0 (this device) | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| +1 | K122199 | PREXION3D Eclipse | The Yoshida Dental Mfg. Co., Ltd. | 2013 | — |
| +2 | K161881 | PreXion3D Excelsior | Prexion Corporation | 2016 | — |
| +2 | K152489 | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray | Panoramic Corp. | 2016 | — |
| +1 | K122806 | Image Works Panoura | Mic International | 2013 | — |
| +3 | K210820 | EAGLE EDGE AXR90 and AXR120 | Alliage S/A Industrias Medico Odontológica | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K093683 | Orthopantomograph OP300Summary page 2…KET NOTIFICATION 5 10(k) e. Predicate devices The PANOURA 18S is substantially equivalent to the following legally marketed device: 510(k): K093683 Trade name: ORTHOPANTOMOGRAPH 0P300 Product code: MUR The predicate device is hereinafter… | 2010 |
What descends from it? (11)
See all 113 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 14 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K122199 (The Yoshida Dental Mfg. Co., Ltd., 2013) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K093683.
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. 2011, this device’s year, is highlighted.
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 PANOURA 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The device must only be operated and used by dentists and other legally qualified professionals.
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/K111231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111231: Panoura 18S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111231
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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