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The Trophy Radiologie digital imaging kit, DIGIPAN, can replace the conventional film for primary diagnostic purpose. The image generated is displayed on a computer monitor. The image can then be archived through computer storage and archival means. Referral copies of the image can be obtained with optional hard copy systems.

DIGIPAN/DPI Digital Kit for Panoramic X-ray Device

This document is a 510(k) clearance letter from the FDA for the Trophy Radiologie DIGIPAN/DPI Digital Kit for Panoramic X-ray Device, dated December 21, 2001. It is a clearance for market, based on substantial equivalence to a predicate device.

The document does not contain information about acceptance criteria, device performance, sample sizes used for testing, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used, or training set details.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encience of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)." This means the device met the criteria for substantial equivalence to an existing device, rather than going through a de novo review that would typically involve establishing new acceptance criteria and conducting detailed performance studies against those criteria.

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