Search Results

Brasseler GEM is a USB-driven digital intraoral x-ray sensor which is intended to acquire dental radiographic images. Brasseler GEM must be operated by healthcare professionals who have been trained and are competent using various methods of acquiring radiographic images of dental anatomy. Brasseler GEM can be used with dental positioning devices and holders to assist with aligning an x-ray source beam with the sensor and anatomy. Brasseler GEM can also be aligned by hand with assistance of patient.

Brasseler GEM is a USB-driven digital sensor designed for health care professionals already acquainted with the standard procedures for acquiring dental intraoral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using appropriate additional diagnostic aides, professional judgement, and experience. Brasseler GEM10 is for pediatric use and adult periapical use, GEM15 is for pediatric and adult bitewing and periapical use, and GEM20 is for adult use including bitewings. The Brasseler GEM design uses advanced ergonomic principles with four beveled corners, a moderate profile, and a rounded casing providing enhanced comfort for patients. Brasseler GEM is positioned in the patient's mouth in the same manner as intraoral film is positioned. Brasseler GEM has a CMOS x-ray imager that creates a digital image from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to Brasseler GEM through the standard USB port. Image analysis software is not part of the submission. For Brasseler GEM to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer. Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings. Brasseler GEM capture x-ray images suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions. Inadequate images may result in misdiagnosis thereby subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient. Functions of the Brasseler GEM detector are controlled by software (firmware). The software of Brasseler GEM is of Moderate Level of Concern and is not based on the software of the predicate, Clio Prime. Brasseler GEM shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs. Brasseler GEM can be used either in combination with positioners manufactured to facilitate the positioning and alignment with an x-ray beam, or it may also be positioned by hand with the assistance of the patient. Brasseler GEM can be used with patients of any age, providing the correct positioning of the sensor in the patient mouth can be realized. Using Brasseler GEM is a suitable diagnostic method and may offer reduced radiation exposure compared to analog procedures. Available software image enhancement tools may enhance sensitivity and consequently reduce errors introduced by subjective analysis. Brasseler GEM can perform and achieve the same type of two-dimensional images as conventional (traditional) film sizes 0, 1 and 2. Brasseler GEM cannot be used to, or as a substitution for extraoral or other types of dental x-ray. When using Brasseler GEM and software as a diagnostic aide, clinical experience and a combination of the diagnostic aides should be used to form a diagnosis and should not be solely relied upon for diagnosis.