510(k) · Cleared
ClearedOrthophos DS/DC Ceph, Orthophos 5/Plus/CD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Dec 6, 2001 as substantially equivalent to K972312 (Siemens AG, 1997) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1997. 16 later devices descend from it.
- Decided
- Dec 6, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972312 (1997). 2 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972312 Siemens Orthophos DS/DS CephSiemens AG · 1997
- This deviceK013650 Orthophos DS/DC Ceph, Orthophos 5/Plus/CDSirona Dental Systems GmbH · 2001
- Descendant · cites it directly · 15 of its ownK033073 Orthophos XG DS/CephSirona Dental Systems GmbH · 2003
- Descendant · 2 generations on · 7 of its ownK103711 Orthophos XG 3D / CephSirona Dental Systems GmbH · 2011
- Descendant · 3 generations on · 5 of its ownK150217 Orthophos SLSirona Dental Systems GmbH · 2015
- Descendant · 2 generations on · 5 of its ownK122918 Rayscan a-ExpertRay Co., Ltd. · 2013
- Descendant · 3 generations on · 4 of its ownK131693 Rayscan a-ExpertRay Co., Ltd. · 2013
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K033073Orthophos XG DS/CephSirona Dental Systems GmbH · 2003 · cites it directly15descendants
- K103711Orthophos XG 3D / CephSirona Dental Systems GmbH · 2011 · 2 generations on7descendants
- K150217Orthophos SLSirona Dental Systems GmbH · 2015 · 3 generations on5descendants
- K122918Rayscan a-ExpertRay Co., Ltd. · 2013 · 2 generations on5descendants
- K131693Rayscan a-ExpertRay Co., Ltd. · 2013 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972312 | Siemens Orthophos DS/DS Ceph | Siemens AG | 1997 | — |
| 0 (this device) | K013650 | Orthophos DS/DC Ceph, Orthophos 5/Plus/CD | Sirona Dental Systems GmbH | 2001 | — |
| +1 | K033073 | Orthophos XG DS/Ceph | Sirona Dental Systems GmbH | 2003 | — |
| +2 | K103711 | Orthophos XG 3D / Ceph | Sirona Dental Systems GmbH | 2011 | — |
| +3 | K150217 | Orthophos SL | Sirona Dental Systems GmbH | 2015 | — |
| +2 | K122918 | Rayscan a-Expert | Ray Co., Ltd. | 2013 | — |
| +3 | K131693 | Rayscan a-Expert | Ray Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K972312 | Siemens Orthophos DS/DS CephSummary page 1…ommon/Usual Name: Dental panoramic and cephalometric X-ray system Classification Name: Extraoral source dental X-ray system 3. PREDICATE DEVICE Orthophos DS / DS Ceph (K972312) Orthophos 5 / PLUS / CD (K983057) 4. INTENDED USE The Orthophos PLUS DS / PLUS DS Ceph is an extraoral source dental X-ray sys… | 1997 |
| * | K983057 | Orthophos 5/Plus/CDSummary page 1…and cephalometric X-ray system Classification Name: Extraoral source dental X-ray system 3. PREDICATE DEVICE Orthophos DS / DS Ceph (K972312) Orthophos 5 / PLUS / CD (K983057) 4. INTENDED USE The Orthophos PLUS DS / PLUS DS Ceph is an extraoral source dental X-ray system intended to produce X-rays for… | 1998 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033073 | Orthophos XG DS/Ceph | 2003 | 15 |
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?
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 Orthophos PLUS DS / PLUS DS Ceph is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
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/K013650 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013650: Orthophos DS/DC Ceph, Orthophos 5/Plus/CD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013650
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026