510(k) · Cleared
ClearedCranex 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 Dec 17, 2004 as substantially equivalent to K972312 (Siemens AG, 1997) and 1 other predicate after a 16-day review. Its family tree reaches back 2 generations to 1997. 4 later devices descend from it.
- Decided
- Dec 17, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972312 (1997). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK972312 Siemens Orthophos DS/DS CephSiemens AG · 1997
- 1 generation backK040382 Cranex Basex D or Cranex Excel DSoredex Palodex Group OY · 2004
- This deviceK043307 Cranex DSoredex Palodex Group OY · 2004
- Descendant · cites it directly · 1 of its ownK110371 Encompass HF100- Eagle Panoramic/Cephalometric X-RayPanoramic Corp. · 2011
- Descendant · cites it directly · 1 of its ownK063459 Cranex NovusSoredex Palodex Group OY · 2006
- Descendant · 2 generations on · 0 of its ownK141130 EncompassPanoramic Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK092591 Orthopantomograph OP30Instrumentarium Dental, Palodex Group OY · 2009
Most influential descendants
Showing 4 of 4 · See all- K110371Encompass HF100- Eagle Panoramic/Cephalometric X-RayPanoramic Corp. · 2011 · cites it directly1descendant
- K063459Cranex NovusSoredex Palodex Group OY · 2006 · cites it directly1descendant
- K141130EncompassPanoramic Corp. · 2014 · 2 generations on0descendants
- K092591Orthopantomograph OP30Instrumentarium Dental, Palodex Group OY · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972312 | Siemens Orthophos DS/DS Ceph | Siemens AG | 1997 | — |
| −1 | K040382 | Cranex Basex D or Cranex Excel D | Soredex Palodex Group OY | 2004 | — |
| 0 (this device) | K043307 | Cranex D | Soredex Palodex Group OY | 2004 | — |
| +1 | K110371 | Encompass HF100- Eagle Panoramic/Cephalometric X-Ray | Panoramic Corp. | 2011 | — |
| +1 | K063459 | Cranex Novus | Soredex Palodex Group OY | 2006 | — |
| +2 | K141130 | Encompass | Panoramic Corp. | 2014 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K972312 | Siemens Orthophos DS/DS CephSummary page 1…/ EHD Predicate Device We consider that Cranex D is substantially equivalent in design, composition and function with Orthophos DS / DS Ceph (K972312) and with Cranex Basex D or Cranex Excel D (K040382). Product Description Cranex D is a panoramic ext… | 1997 |
| * | K040382 | Cranex Basex D or Cranex Excel DSummary page 1…anex D is substantially equivalent in design, composition and function with Orthophos DS / DS Ceph (K972312) and with Cranex Basex D or Cranex Excel D (K040382). Product Description Cranex D is a panoramic extraoral source dental x-ray system, which produces di… | 2004 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K110371 (Panoramic Corp., 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K972312.
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 D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043307: Cranex D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043307
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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