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declipseSPECT Laparoscopy is an enhancement of the declipseSPECT system for minimal invasive surgery using a laparoscopic gamma probe. declipseSPECT Laparoscopy works in conjunction with a laparoscopic nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Laparoscopy is intended to use the said detector and generate images of the distribution of radionuclides in the human body and determine the 3D localization of these radionuclides relative to surgical instruments by means of tracking technologies and image reconstruction techniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing in-situ, such as SPECT/CT and PET/CT. declipseSPECT Laparoscopy is used intraoperatively or on pathological specimens. For any intraoperative usage the laparoscopic gamma probe needs to be covered by a protective sterile cover. The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicians that are trained to use the system. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel. declipseSPECT Laparoscopy is compatible currently to following nuclear uptake detectors: | Probe<br>Manufacturer | Probe Model | Probe Handle Model | Energy range of<br>gamma rays | |-----------------------|-------------|--------------------|-------------------------------| | Crystal Photonics: | SG04 | CXS-OP-SZL-45 | 60-245 keV |

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declipseSPECT Viewer works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Viewer is intended to use the said detector and generate images of the distribution of radionuclides in the human body and determine the 3D localization of these radionuclides relative to surgical instruments by means of tracking technologies and image reconstruction techniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing in-situ, such as SPECT/CT and PET/CT. declipseSPECT Viewer may also be used intraoperatively or on pathological specimens if a protective cover is used to cover the nuclear uptake detector. dedipseSPECT Viewer may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicist and physicians that are trained to use the system. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

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Confident Surgery Suite 300 (CSS300) works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. CSS300 is intended to extend the said detector and generate images of the distribution of radionuclides in the human body by means of tracking technologies and image reconstruction techniques. CSS300 extends currently all nuclear uptake detectors by Crystal Photonics. CSS300 may also be used intraoperatively or on pathological specimens if a protective sheath is used to cover the nuclear uptake detector. CSS300 may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

CSS300 is an extension for nuclear uptake detectors designed to obtain 3D images from small organs and structures labeled using radionuclides emitting gamma rays by acquiring data while moving freely with the hand the said detectors. Examples of nuclear uptake detectors compatible with CSS300 are the nuclear uptake detectors by Crystal Photonics. CSS300 includes also analysis and display equipment, an optical camera, a cart and an ergonomic arm which allows positioning the required positioning sensor and camera in a suitable position while using the device.

The SI Handheld Gamma Finder is indicated to detect and quantify the gamma photons in the body intra-operatively or extra-operatively, when gamma emitting radiopharmaceuticals are administered into the human body.

The gamma-detector, energy discriminator, amplifier, controls and energy supply have been assembled into a single hand-held unit SI-Handheld Gamma Finder® (HGF), which is shielded by a biocompatible polymer. The probe's shape is conical; its shaft tapers off towards a tip that holds the collimator, the crystal and the PINdiode while a head of larger diameter houses the display, menu buttons, and other components. The device is held in one hand by the middle of the shaft. Outer diameters and weight are designed so as to allow single-handed use over periods of time longer than those of routine sentinel biopsies. The polymer casing of SI HGF is water resistant and thus allows extended cleansing with commercial surface disinfectants. The probe tip may even be immersed in disinfectants for several hours. This fulfills standard requirements of hospital hygiene. Disinfection of the probe is comparable to other, larger probes that are being used like Gamma Finder in conjunction with disposable sterile plastic covers. The HGF can be switched on or off by any key. Results are numerically shown in the liquid crystal display in counts per second (CPS), and updated every second. The HGF has only four keys. The currently measured value can be retained in the display for 5 seconds by pressing Key A. The HGF is packaged and transported in a small suitcase. The HGF can only be operated by a Sonnenschein Lithium Battery (SL2770/T), with a maximum charging current of 15 mA. It is not user replaceable. The display of the HGF will display an battery symbol, warning the user the battery life is approximately 20 hours from exhaustion. If the battery is exhausted, the display will show "LobAt". The only accessory is a Sterile Sleeve (No. SI-FOL-101) that accompanies each device, along with the User Manual.

For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region in open-surgical , laparoscopic or thoracoscopic surgical procedures.

The Modified GAMMA GUIDANCE SYSTEM is a portable battery powered system used for non-imaging procedures. It includes a hand-held sensor probes, a counting unit, and a cable interconnecting the two.

The intended use of the device here in question, i.e. the Care Wise C-Trak Automatic Analyzer, remains unchanged from the intended use of prior predicate Care Wise and other portable radioisotope detectors. The Care Wise C-Trak Automatic Analyzer is designed- as are all similar devices - to detect and quantify nuclear radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.

The Care Wise C-Trak Automatic Analyzer consists of a battery-powered analyzer designed to operate a hand held probe, display the data from the detected radiation, and display and control the system's operating parameters.

The Neoprobe® Model 1500 Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.

The Neoprobe® Model 1500 Portable Radioisotope Detector ("Model 1500") consists of (1) a microcomputer-based control unit: (2) a 12 mm collimated detector probe tip, a 12 mm non-collimated detector probe tip, and a 19 mm noncollimated probe tip, all of which are reusable, steam sterilizable and contain a cadmium zinc telluride crystal gamma ray detector; (3) a disposable sterile probe handle with an attached polypropylene cable; (4) a check source disk containing a known quantity of 1201; and (5) a chrome-plated Teflon-lined lead noise adjustment fixture used for periodic verification that the system continues to meet factory calibration readings.

The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. The GEN 1C in indicated for external and intraoperative detection of radioactivity in body tissues or organs in medical procedures where gamma emitting isotopes are administered.

The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector ("Model 1000") consists of a microcomputer-based control unit, a cadmium zinc telluride gamma ray detector probe, a cable used to connect the probe to the control unit, a check source containing a known quantity of 129 I, and a chrome-plated Teflon-lined lead noise adjustment fixture used for periodic verification that the system continues to meet factory calibration readings. The detector probe is available in two sizes: (1) a detector probe with a 19 mm external diameter and a detector diameter of 15 mm; and (2) a detector probe with an 11 mm external diameter and a detector diameter of 7 mm. Optional accessories include a detector probe collimator and a detector probe shield.