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The OPTEO digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional xray tube, and placing an electronic sensor in the patient's mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures the images into a computer. The computer, which is not provided by OWNDY, controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions. The Opteo digital system is designed to collect instant images of human oral tissue and teeth without the use of a conventional x-ray film. It is used with a conventional x-ray tube and a computer for dental radiographic imaging. The Opted is covered with a single use disposable sheath and positioned in the oral cavity opposite the tooth the dentist wishes to x-ray tube (which is not part of Opted) is pointed at the sensor and activated. The emitted radiation from the x-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to.

Intraoral detector for capturing x-ray images from an extraoral source generator. Captured images are automatically transmitted in digital form via USB connection for display, storage, and printing on the practitioner's computer using imaging software. Intraoral detector for capturing x-ray images from an extraoral source generator. Captured images are automatically transmitted in digital form via USB connection for display, storage, and printing on the practitioner's computer using imaging software. The device is a modified version of the predicate and is similar in terms of basic component materials, overall design, and labeling ... Both the original predicate and the 510(k) device are covered with a single-use disposable hygienic sheath and positioned in the patient's mouth for radiographic examination of areas of the oral region. An external x-ray generator emits radiation that is partially absorbed by bone areas and soft tissue. Unabsorbed x-rays strike a scintillator in the device which converts the x-ray energy beam into light. An optical fiber filters this stream of photons. The light then hits an electron light sensor (CMOS) that in turn reemits it in the form of an electrical pulse. The resulting pixel matrix is sent to a connected computer and saved as a gray-scale image. Imaging software on the PC processes the image and enables nearly instant viewing and storage of the x-ray image ... The only significant modification to the original Visteo was integration of control box electronics with sensor board electronics in order to eliminate the control box, as more fully discussed in Section 12.

I-MAX Touch 3D, panoramic X-ray imaging system with cephalostat, is an extra-oral source Xray system which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry. It also has the capability, using the CBVT technique, to generate dentomaxillofacial 3D images. The device uses a cone shaped X-ray beam projected on a flat panel detector; the examined volume image is reconstructed to be viewed on 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals

The I-MAX Touch 3D is a panoramic x-ray system utilizing digital imaging. It can be equipped with a cephalostat. The device can be equipped with accessories to fulfill different diagnostic needs. The images are acquired by a flat panel detector and are displayed on a monitor; image processing, manipulation, archiving, communication and 3D reconstruction (starting from cross-sectional images taken using CBVT (Cone Beam Volumetric Tomography) technique) are performed using a computer.

The VISTEO digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional x-ray tube, and placing an electronic sensor in the patient's mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures the images into a computer. The computer, which is not provided by OWANDY, controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, controls, image inversion, and pseudo color renditions. The main advantages of this digital imaging system are : - high definition ensuring high-value diagnostics - interface allowing image processing in the PC In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.

The VISTEO system consists of the following components: the sensor and its cable, a USB/data box, with sensor adapter. The sensor body is made hermitically sealed shell which encapsulates a black and white CMOS chip. The sensor attaches the USB/data box (processing unit) via a 1 meter removable cable. The sensor, when exposed to radiation, captures image in the form of a charge pattern on its surface (CMOS). The resulting electronic signals are digitised and sent to a computer for image presentation. According to the 2 different models, there are two possible sizes: D001 model (size 1): the outer dimensions are approximately 1.5 x 1.0 x 0.3 inches (38,9 x 24,9 x 7,4mm) with rounded edges. D002 model (size 2): the outer dimensions are approximately 1.7 x 1.2 x 0.3 inches (42.9 x 30.9 x 7,4mm) with rounded edges. The USB/data box relays the data from to the computer for display. The data box is a 5.4 x 1.8 x 0.7 inches (13.8x 1.8 x 0.7 cm) box with an USB cable connection. Positioner accessories : 2 bite blocks (bitewing and endo) + 1 aiming ring

The I-MAX Touch (PAN and CEPH) is intented for dental radiographic examination of the teeth and specifically for panoramic examinations, TMJ studies, implantology and Cephalometry. It is to be only used by dental practitioners and/or radiologists. The I-Max Touch (PAN and Ceph) is a digital image acquisition system to be used in conjunction with a Villa Sistemi Medicali Digital Panoramic X-ray System, such as I-Max Plus or Strato D, to capture images by a sensor, digitalize the image, review images and format images to be sent to a PC, according to a standard protocol, through the existing acquisition board of panoramic system.

Extra oral source X-Ray System

The KRYSTAL-X WiFi digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional x-ray tube (which is a third party device, not part of Krystal-X WiFi), and placing an electronic sensor in the patients' mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures instantaneously and transmits the images by WiFi to the computer. The computer and imaging software (which is not provided by OWANDY) controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions. The main advantages of this digital imaging system are: high definition, ensuring high-value diagnostics, and reduction of X-rav dosage. In no case, is it to be used directly by the patient. So, it is used exclusively in a healthcare specific environment. The WiFi device modification to our model Krystal-X in no way alters the indications for use of this device beyond what was originally approved in K053172.

Krystal-X WiFi is a wireless digital X-ray sensor for intraoral radiography.

The IMAX CEPH digital X-ray sensor is intended to capture extra oral x-ray images of a patient's head when exposed to X-rays for diagnostic purposes.

The process is automatic and continues transmitting the digital image to a Personal Computer VIA USB interface.

The UNIVERSAL-X digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional x-ray tube, and placing an electronic sensor in the patients mouth instead of conventional film. The sensor , upon radiation exposure, automatically captures the images into a computer. The computer , which is not provided by OWANDY , controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions. The main advantages of this digital imaging system are - high definition ensuring high-value diagnostics - interface allowing image processing in the PC In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment. The UNIVERSAL-X digital system is designed to collect instant images of human oral tissue and teeth without the use of a conventional x-ray film. It is used with a conventional X-ray tube and a Computer for dental radiographic imaging. The Universal-X is covered with a single use disposable sheath and positionned in the oral cavity opposite the tooth the dentists wishes to xray. The dental X-ray tube (which is not part of Universal-X) is pointed at the sensor and activated. The emitted radiation from the X-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to. In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.

The UNIVERSAL-X system consists of the following components : the sensor and its cable, a data box, and a PC with sensor adapter. The sensor body is made hermitically sealed shell which encapsulates a black and white CCD. The sensor attaches the processing unit via a 3 meters cable. The outer dimensions are approximately 42.77 X 28.40 mm with rounded edocs. The datas/USB box relays the data to the computer for display. The data box is a 44.5 mm X 161.2 X 154 mm box with an USB cable connection. The sensor, when exposed to radiation, captures image in the form of a charge pattern on its surface (CCD). The resulting electronic signals are digitised and sent to a computer for image presentation.