510(k) · Cleared
ClearedImage Works Panoura
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mic International · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Mar 8, 2013 as substantially equivalent to K111231 (The Yoshida Dental Mfg. Co., Ltd., 2011) and 1 other predicate after a 176-day review. Its family tree reaches back 7 generations to 1997. 2 later devices descend from it.
- Decided
- Mar 8, 2013
- Review
- 176 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K973598 (1997). 15 ancestors in all, the oldest K930338 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 5 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 4 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 3 generations backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 2 generations backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- 1 generation backK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- This deviceK122806 Image Works PanouraMic International · 2013
- Descendant · cites it directly · 1 of its ownK182198 Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK222666 X-View 3D Pan/X-View 2D PanTrident S.R.L · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −6 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −5 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −4 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −3 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −2 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| −1 | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| 0 (this device) | K122806 | Image Works Panoura | Mic International | 2013 | — |
| +1 | K182198 | Panoura X-ERA PF/NF/MF | The Yoshida Dental Mfg. Co., Ltd. | 2019 | — |
| +2 | K222666 | X-View 3D Pan/X-View 2D Pan | Trident S.R.L | 2023 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K111231 | Panoura 18SSummary page 2…nd used by dentists and other legally qualified professionals. h. Statement of substantial equivalence The IMAGEWORKS PANOURA is modified from the PANOURA 18S (k1 1123 1) by adding 3D imaging. The characteristics except 3D imaging of the IMAGE WORKS PANOURA are identical to those of the PAN… | 2011 |
| * | K093683 | Orthopantomograph OP300Summary page 2…llowing legally marketed device: 5 10(k): KI 11231 Trade name: PANOURA1I8S Product code: MUR 5 10(k): .K093683 Trade name: ORTHOPANTOMOGRAPH 0P300 Product code: MUH The predicate devices are hereinaf… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182198 | Panoura X-ERA PF/NF/MF | 2019 | 1 |
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 16 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K182198 (The Yoshida Dental Mfg. Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K111231.
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. 2013, 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 IMAGEWORKS PANOURA 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 of examined volume for the reconstruction
of 3D view. 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/K122806 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122806: Image Works Panoura.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122806
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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