510(k) · Cleared
Recalled · 2006Cranex Tome Ceph, or Cranex Tome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orion Corporation Soredex · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Mar 27, 1998 as substantially equivalent to K884650 (Orion Corp., 1989) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1988. It has been recalled once.
- Decided
- Mar 27, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- EHD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K880982 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK880982 Oralix Pan DC Iii Ceph or Panoramic Mode OnlyOrion Corporation Soredex · 1988
- This deviceK974877 Cranex Tome Ceph, or Cranex TomeOrion Corporation Soredex · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880982 | Oralix Pan DC Iii Ceph or Panoramic Mode Only | Orion Corporation Soredex | 1988 | — |
| 0 (this device) | K974877 | Cranex Tome Ceph, or Cranex Tome | Orion Corporation Soredex | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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 |
|---|---|---|---|
| * | K884650 | Resubmitted ScanoraSummary page 1…nex Tome Ceph Common or Usual Name: Tomographic X-ray system Classification Name: System, Tomographic, Radiographic 90 IZF III Substantial Equivalent Devices Scanora (K884650) marketed by Orion Corporation Soredex, Tomographic functions Oralix Pan DC III Ceph (or Cranex 3 Ceph) (K880982) marketed by Ori… | 1989 |
| * | K880982 | Oralix Pan DC Iii Ceph or Panoramic Mode OnlySummary page 1…hic 90 IZF III Substantial Equivalent Devices Scanora (K884650) marketed by Orion Corporation Soredex, Tomographic functions Oralix Pan DC III Ceph (or Cranex 3 Ceph) (K880982) marketed by Orion Corporation Soredex , cephalometric functions IV Product Description Cranex Tome Ceph is a hi… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2006 | Not classified | Z-0816-2007 | Other | There may be a material defect in the up/down movement axle of the unit. This may cause the upper part of the unit to suddenly come down. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a 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?
Tomographic X-ray System, which is intended for diagnostic dental radiography at the dento-maxillofacial region and additionally cephalometry. The imaging methods are narrow beam radiography and spiral tomography and central projection cephalometry.
The method of image reception is film / intensifying screens.
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/K974877 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974877: Cranex Tome Ceph, or Cranex Tome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974877
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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