510(k) · Cleared
ClearedPanoura X-ERA PF/NF/MF
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 Jan 31, 2019 as substantially equivalent to K122806 (Mic International, 2013) after a 170-day review. Its family tree reaches back 8 generations to 1997. 1 later device descends from it.
- Decided
- Jan 31, 2019
- Review
- 170 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K973598 (1997). 16 ancestors in all, the oldest K930338 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 6 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 5 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 4 generations backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 3 generations backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- 2 generations backK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- 1 generation backK122806 Image Works PanouraMic International · 2013
- This deviceK182198 Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK222666 X-View 3D Pan/X-View 2D PanTrident S.R.L · 2023
Most influential descendants
Showing 1 of 1 · See all- K222666X-View 3D Pan/X-View 2D PanTrident S.R.L · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −7 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −6 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −5 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −4 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −3 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| −2 | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| −1 | K122806 | Image Works Panoura | Mic International | 2013 | — |
| 0 (this device) | K182198 | Panoura X-ERA PF/NF/MF | The Yoshida Dental Mfg. Co., Ltd. | 2019 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K122806 | Image Works PanouraSummary page 6…d. Predicate devices Panoura X-ERA PF/NF/MF is substantially equivalent to the following legally marketed device: 510(k): K122806 Trade name: IMAGEWORKS PANOURA Regulation Name: Extraoral source x-ray… | 2013 |
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 |
|---|---|---|---|
| K222666 | X-View 3D Pan/X-View 2D Pan | 2023 | 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 22 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K222666 (Trident S.R.L, 2023) has gone furthest, with 0 descendants of its own.
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. 2019, 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 X-ERA PF/NF/MF 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 Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for general populations. The device must only be operated and used by dentists and other legally qualified professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182198: Panoura X-ERA PF/NF/MF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182198
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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