510(k) · Cleared
ClearedTrophypan C with Orthoimaging/Omsimaging Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Apr 7, 2004 after a 36-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 7, 2004
- Review
- 36 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | TROPHYPAN/TROPHYPAN C System Named without a submission number |
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.
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 PRACTICEWORKS, TROPHYPAN/TROPHYPAN C System with the OrthoimagingSystem accessory is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce dental radiographic X-ray images of the dento-maxillo-facial area and store these images along with relevant patient examination information for use by dentists. By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging System accessory, the dentist can acquire…
Read the full statement (106 words)
The PRACTICEWORKS, TROPHYPAN/TROPHYPAN C System with the OrthoimagingSystem accessory is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce dental radiographic X-ray images of the dento-maxillo-facial area and store these images along with relevant patient examination information for use by dentists.
By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging System accessory, the dentist can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040556: Trophypan C with Orthoimaging/Omsimaging Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040556
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026