# K040556: Trophypan C with Orthoimaging/Omsimaging Accessory

- Pathway: 510(k) (Special)
- Applicant: Eastman Kodak Company
- Decided: Apr 7, 2004 after 36 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TROPHYPAN/TROPHYPAN C System: named in the summary without a submission number

## Indications for use
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

Source page: https://510kreport.com/device/K040556
Methodology: https://510kreport.com/methodology