510(k) · Cleared
ClearedCranex Basex D or Cranex Excel D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soredex Palodex Group OY · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Jul 13, 2004 as substantially equivalent to K983057 (Sirona Dental Systems GmbH, 1998) and 1 other predicate after a 147-day review. Its family tree reaches back 1 generation to 1997. 5 later devices descend from it.
- Decided
- Jul 13, 2004
- Review
- 147 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972312 (1997). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972312 Siemens Orthophos DS/DS CephSiemens AG · 1997
- This deviceK040382 Cranex Basex D or Cranex Excel DSoredex Palodex Group OY · 2004
- Descendant · cites it directly · 4 of its ownK043307 Cranex DSoredex Palodex Group OY · 2004
- Descendant · 2 generations on · 1 of its ownK110371 Encompass HF100- Eagle Panoramic/Cephalometric X-RayPanoramic Corp. · 2011
- Descendant · 2 generations on · 1 of its ownK063459 Cranex NovusSoredex Palodex Group OY · 2006
- Descendant · 3 generations on · 0 of its ownK141130 EncompassPanoramic Corp. · 2014
- Descendant · 3 generations on · 0 of its ownK092591 Orthopantomograph OP30Instrumentarium Dental, Palodex Group OY · 2009
Most influential descendants
Showing 5 of 5 · See all- K043307Cranex DSoredex Palodex Group OY · 2004 · cites it directly4descendants
- K110371Encompass HF100- Eagle Panoramic/Cephalometric X-RayPanoramic Corp. · 2011 · 2 generations on1descendant
- K063459Cranex NovusSoredex Palodex Group OY · 2006 · 2 generations on1descendant
- K141130EncompassPanoramic Corp. · 2014 · 3 generations on0descendants
- K092591Orthopantomograph OP30Instrumentarium Dental, Palodex Group OY · 2009 · 3 generations on0descendants
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) | K040382 | Cranex Basex D or Cranex Excel D | Soredex Palodex Group OY | 2004 | — |
| +1 | K043307 | Cranex D | Soredex Palodex Group OY | 2004 | — |
| +2 | K110371 | Encompass HF100- Eagle Panoramic/Cephalometric X-Ray | Panoramic Corp. | 2011 | — |
| +2 | K063459 | Cranex Novus | Soredex Palodex Group OY | 2006 | — |
| +3 | K141130 | Encompass | Panoramic Corp. | 2014 | — |
| +3 | K092591 | Orthopantomograph OP30 | Instrumentarium Dental, Palodex Group OY | 2009 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 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? (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 |
|---|---|---|---|
| * | K983057 | Orthophos 5/Plus/CDSummary page 1…Predicate Device We consider that Cranex Basex 0 and Cranex Excel D are substantially equivalent in design, composition and function with Orthophos DS (K983057 & K972312). Product Description Cranex Basex D and Cranex Excel 0 are panoramic extraoral source dental x-ray… | 1998 |
| * | K972312 | Siemens Orthophos DS/DS CephSummary page 1…icate Device We consider that Cranex Basex 0 and Cranex Excel D are substantially equivalent in design, composition and function with Orthophos DS (K983057 & K972312). Product Description Cranex Basex D and Cranex Excel 0 are panoramic extraoral source dental x-ray systems,… | 1997 |
| † | K880982 | Oralix Pan DC Iii Ceph or Panoramic Mode Only | 1988 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043307 | Cranex D | 2004 | 4 |
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 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 Cranex Basex D and Cranex Excel D dental panoramic equipments are indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040382 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040382: Cranex Basex D or Cranex Excel D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040382
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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