510(k) · Cleared
ClearedFONA Pan/Ceph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fona S.R.L · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Nov 3, 2016 as substantially equivalent to K031801 (Blue X Imaging Srl, 2003) and 1 other predicate after a 196-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Nov 3, 2016
- Review
- 196 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K973642 (1997). 22 ancestors in all, the oldest K961826 (1996). No later device cites it as a predicate yet.
- Root · 8 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 7 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 6 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 5 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 4 generations backK102124 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2010
- 3 generations backK120263 Volux 21C, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2012
- 2 generations backK123070 Galileos FamilySirona Dental Systems GmbH · 2013
- 1 generation backK150217 Orthophos SLSirona Dental Systems GmbH · 2015
- This deviceK161131 FONA Pan/CephFona S.R.L · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −7 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −6 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −5 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −4 | K102124 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2010 | — |
| −3 | K120263 | Volux 21C, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2012 | — |
| −2 | K123070 | Galileos Family | Sirona Dental Systems GmbH | 2013 | — |
| −1 | K150217 | Orthophos SL | Sirona Dental Systems GmbH | 2015 | — |
| 0 (this device) | K161131 | FONA Pan/Ceph | Fona S.R.L | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K031801 | Pantos, Models: Pantos 16, and Pantos DGSummary page 4…ct code: MUH 1.3 Predicate devices The new FONA Pan/Ceph device is substantially equivalent to the following legally marketed predicate devic- es: PantOs (K031801) manufactured by Blue X Imaging Srl, the former company name of FONA Srl, primary predicate device: Regulation name: Ex… | 2003 |
| * | K150217 | Orthophos SLSummary page 4…e former company name of FONA Srl, primary predicate device: Regulation name: Extraoral source X-ray system Product codes: MUH, EHD, MQB. ORTHOPHOS SL (K150217) manufactured by Sirona Dental Systems GmbH, which incorporates, for the panoramic and cephalometric modalities, the same typ… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- None of the 22 ancestors has a recall.
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. 2016, 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 FONA Pan/Ceph device, comprising models FONA XPan DG, FONA XPan DG Plus, FONA ART Plus, and FONA ART Plus C, is an extraoral source dental X-ray system intended to perform panoramic or cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images.
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/K161131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161131: FONA Pan/Ceph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161131
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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