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The Respiratory Gating System AZ-733VI is intended to be used with diagnostic x-ray or radiation therapy systems to gate these devices on and off when target points of the patient's respiratory cycle are within preset limits.

The Respiratory Gating System AZ-733VI employs a respiratory sensor which can be fixed directly to or near to a patient, and detects the respiratory motion changes according to the type of sensor, the Load Cell (standard component), the Laser Sensor (option component) or the IRP Sensor (option component). The signal from the sensor is primarily amplified at the Amp Box which is attached to each Respiratory Sensor and sent to the Sensor Port as an analog signal. At the Sensor Port, the analog signal is coarsely adjusted manually, converted to digital signal, smoothed by moving-average method and processed to detect a respiratory phase. Then, as a respiratory information, the respiratory waveform and the respiratory phase are sent to the Application on the Personal Computer via the Relay Box. The Application performs the fine adjustment of the selected respiratory waveform by the user manually or automatically. The user also sets a Gate signal output condition and selects a mode for the method of generating Gate signal. This Gate signal is output to external equipment (image diagnostic equipment such as a whole body CT equipment, linear accelerator system and radiotherapy equipment) from the Relay Box or the Sensor Port when those respiratory signals reach the preset conditions set by the user. The status of the Gate signal ON and OFF is also displayed on the LCD Display. The Application has a function of managing patient information. This function involves the input, registration, referring, revision and delete of patient information. The Application also provides the function of recording, playback, referring and output by a text file format of respiratory information and Gate signal ON/OFF status as well as Beam signal ON/OFF status.

The AZ-733 Respiratory Gating System is intended to be used with diagnostic x-ray or radiation therapy systems to gate these devices on and off when target points of the patient's respiratory cycle are within preset limits.

The AZ-733 Respiratory Gating System system employs a respiratory sensor which can be fixed directly to or nearly to a patient, and detects the respiratory motion changes according to the type of sensor, a load cell (standard) or laser sensor (optional). The Load Cell detects the mechanical expansion of the thoracic cavity resulting from the respiratory motion as the pressure changes of up/downward movement of the chest and abdomen. The Laser Sensor detects the distance change to the chest surface with the expansion of the thoracic cavity resulting from the respiratory motion of the chest and abdomen. The analog signals from the Respiratory Sensor are detected and transmitted to the Sensor Port. There those signals are amplified, converted into digital form, and then output through a cable to the Wave Deck. The Wave Deck processes the signals, changing them into serial format for transmission to the Personal Computer. The Personal Computer monitors the respiratory signals all the time and commands the Wave Deck to output the gating signals when those respiratory signals reach the preset phase of respiration. Those gating (TTL) signals are transmitted to diagnostic imaging apparatus like X-ray CT or radiation therapy equipment.

The Anzai eZ-Scope AN Portable Gamma Camera is indicated for use to image the distribution of radionuclides in the human body using planar imaging techniques. The eZ-Scope may be used intraoperatively or on pathological specimens if a protective sheath is used.

The Anzai EZ-Scope AN Portable Gamma Camera is a currently marketed portable gamma camera. utilizing a solid state detector. rather than a scintilator, to detect gamma rays. The cadmium-zinc-tellurium detector allows sharp energy discrimination and spatial resolution. The detector arrav is made from pixelized cadmium-zinc-telluride (CZT) crystals, with each of the 256 pixels having dimensions of 2 x 2 mm. The system is available in two configurations, eZ-Scope AN and eZ-Scope Light. These differ primarily in the computer, the former model using a desktop computer and the latter a laptop. In the desktop version, the computer is mounted on a cart, while the laptop version does not have a cart. The present 510(k) is for an addition to the indications for use statement (see next section) pertaining to intraoperative use. The user manual has been modified to include instructions for disinfecting the camera head and covering it with a protective plastic sheath to prevent contamination of a sterile field in case of an accidental puncture of the sheath during intraoperative use.