510(k) · Cleared
ClearedPanoura Ultra Pan and Panoura Ultra Pan/Ceph Panoramic/Cephalometric X-Ray Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaycor Intl., Ltd. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Jan 27, 1997 as substantially equivalent to K811210 (Kaycor Intl., Ltd., 1981) after a 39-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Jan 27, 1997
- Review
- 39 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K811210 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK811210 Yoshida-Panoura 10Kaycor Intl., Ltd. · 1981
- This deviceK965072 Panoura Ultra Pan and Panoura Ultra Pan/Ceph Panoramic/Cephalometric…Kaycor Intl., Ltd. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811210 | Yoshida-Panoura 10 | Kaycor Intl., Ltd. | 1981 | — |
| 0 (this device) | K965072 | Panoura Ultra Pan and Panoura Ultra Pan/Ceph Panoramic/Cephalometric X-Ray Unit | Kaycor Intl., Ltd. | 1997 | — |
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 EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 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 |
|---|---|---|---|
| * | K811210 | Yoshida-Panoura 10Summary page 1…his product is similar in design and function to the Yoshida/Kaycor Panoura-10 Panoramic X-ray Unit, and Yoshida Kaycor Panoura-10C Panoramic/Cephalometric X- ray Unit. (K811210) 3. Indications for Use (intended use) The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph will be marketed for diagnostic radiogr… | 1981 |
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?
- Its one ancestor has no recall.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph will be marketed for
diagnostic radiographic use in dental, oral surgery, and orthodontic practices, and in other
medical facilities where these types of dental radiographs are routinely taken. These uses
are typical of the predicate devices in the Panoura-10 series.
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/K965072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965072: Panoura Ultra Pan and Panoura Ultra Pan/Ceph Panoramic/Cephalometric X-Ray Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965072
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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