510(k) · Cleared
ClearedPantos, Models: Pantos 16, and Pantos DG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue X Imaging Srl · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Sep 11, 2003 as substantially equivalent to K972968 (Chicago X-Ray Systems, Inc., 1997) and 2 other predicates after a 92-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Sep 11, 2003
- Review
- 92 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K961826 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961826 DigipanTrophy Radiologie · 1996
- 1 generation backK983283 Signet Dxis Direct X-Ray Imaging SystemSignet Radiology, Inc. · 1998
- This deviceK031801 Pantos, Models: Pantos 16, and Pantos DGBlue X Imaging Srl · 2003
- Descendant · cites it directly · 0 of its ownK161131 FONA Pan/CephFona S.R.L · 2016
Most influential descendants
Showing 1 of 1 · See all- K161131FONA Pan/CephFona S.R.L · 2016 · cites it directly0descendants
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) | K031801 | Pantos, Models: Pantos 16, and Pantos DG | Blue X Imaging Srl | 2003 | — |
| +1 | K161131 | FONA Pan/Ceph | Fona S.R.L | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K972968 | Rotograph PlusSummary page 2…version of Rotograph Plus equipped with digital sensor DXIS by Signet or CDR Pan by Shick is substantially equivalent to PantOs DG. * Rotograph Plus, with 510(k) number K972968, is manufactured by Villa Sistemi Medicali SpA. Via delle Azalee, 3 - 20090 Buccinasco Milan Italy Phone +39 02 488 591, Fax +39… | 1997 |
| * | K983283 | Signet Dxis Direct X-Ray Imaging SystemSummary page 2…Sistemi Medicali SpA. Via delle Azalee, 3 - 20090 Buccinasco Milan Italy Phone +39 02 488 591, Fax +39 02 488 1844, ¢ DXIS, digital panoramic sensor, with 510(k) number K983283, is manufactured by SIGNET S.A.S. 115 bis blv du Général Giraud - 94100 Saint Maur des Fossés, FRANCE Phone +33 1 4883 7300, Fax… | 1998 |
| * | K982661 | CDR - Pan Model 4700Summary page 2…115 bis blv du Général Giraud - 94100 Saint Maur des Fossés, FRANCE Phone +33 1 4883 7300, Fax +33 1 4883 7310, ¢ CDR Pan, digital panoramic sensor, with 510(k) number K982661, is manufactured by Schick Technologies, Inc. 30-00 47" Avenue - Long Island City, NY 11101 Phone 718-482-2159, Fax: 718-937-5962… | 1998 |
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 |
|---|---|---|---|
| K161131 | FONA Pan/Ceph | 2016 | 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 7 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K161131 (Fona S.R.L, 2016) 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.
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 PantOs equipment, model PantOs 16, and PantOs DG are indicated for individuals requiring extra-oral dental radiographic examinations and diagnosis of diseases of the teeth, jaw, and oral structures. It exposes and acquires radiographic images at the dentomaxiliofacial region. Depending on the model, the anatomical structures are visualized either on a radiographic film or on a computer display, through a dedicated image-intensified fluoroscopic x-ray system.
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/K031801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031801: Pantos, Models: Pantos 16, and Pantos DG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031801
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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