Search Results

The equipment is intended to obtain position emission tomography (PET) images of parts of the fit in the patient aperture (e.g. head or breast) to detect abnormal pattern of distribution of a positron emitting radiopharmaceutical. This information can assist in diagnosis, therapeutic outcome assessment.

The SET-5002 PET scanner is designed to image the patient's breast or head which is placed in the aperture provided. The scanner can be easily switched from head to breast mode and back again with the push of a button on the control panel. When positrons are emitted from the radioactive drug administered to the patient, they annihilate electrons in body tissue. That process emits two annihilation photons (hereinafter "gamma rays") with an energy of 511 keV in the 180-degree direction. The PET System collects data by simultaneously counting both of these gamma rays using detectors arranged in a circular configuration. After collecting data for the specified scan time, an image is then reconstructed from that data based on the quantitative distribution of the radioactive drug. The following corrections are necessary for obtaining a quantitative distribution image: Normalization, Attenuation Correction, Scatter Correction, Random Correction, Decay Correction, Standard Time Correction, Count Losses Correction, and Cross Calibration. Operation of the system requires trained persons. The system is designed to be operated in a controlled medical environment such as a hospital or clinic. The unit is supplied with a computer which acquires and stores patient images. The scintillator type is Lutetium. The detectors are SiPM (Silicon photomultipliers).

The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The FDR Visionary Suite enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The FDR Visionary Suite uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.

The FDR Visionary Suite is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The FDR Visionary Suite can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The FDR Visionary Suite consists of an Xray high voltage generator, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. Optionally, the device is also used to perform tomosynthesis radiography by two different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed.

The RADspeed PRO is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed PRO uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.

The RADspeed PRO is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed PRO can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed PRO consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. Optionally, the device is also used to perform tomosynthesis radiography by three different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. Iteration (IR) mode is used to reduce metal artifact in tomosynthesis image. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed, IR mode is recommended to reduce metal artifact.

The Trinias is an angiographic X-ray system, which is used for diagnostic imaging and interventional procedures. The Trinias is intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

This notification is for a modification is the addition of the new MH-700 (ceiling mounted C-Arm). This is the functional equivalent of previous C-Arm MH-400. All options declared under K203535 remain available. The Lateral Angiographic C-arm Support MH-700 allows examination of a patient by fluoroscopy or radiography from different angles with the patient kept in a horizontal position in combination with a Frontal C-arm Support MH-600, an X-ray high voltage unit, X-ray tube unit, X-ray image recording unit (FPD), digital angiography system, catheterization table, etc. The range of available digital receptor panels remains unchanged from our predicate K203535. For installation, ceiling strength is important because the total weight of MH-700 exceeds 1200 kg. The MH-700 features faster movement speeds as compared to the previous model, the MH-400.

The Trinias is an angiographic X-ray system, which is used for diagnostic imaging and interventional procedures. The Trinias is intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

This notification is for a modified device. The modifications are: Updated user interfaces (wireless mouse, keyboard) A new model of catheterization table A new type of digital system console Additional x-ray tube choices Add alternate choices for the same sizes of digital flat panel detectors An additional size of available flat panel detector (12" x 16") An additional type of control cabinet.

The equipment is intended to be used for the fluoroscopy/radiography diagnosis in hospital. The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications. The equipment is used for total patient population. The equipment is NOT intended to be used for Mammography screening. The equipment is NOT intended to be used for interventional procedure. The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations. Stored images in the equipment can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server.

The Shimadzu FLUOROspeed is a universal X-ray RF system offering radiographic, fluoroscopic, and angiographic modes. As compared to our recently cleared system the SONIALVISION G4, (K190373) the positions of the tube head and the digital x-ray receptor panel have been swapped. This was done to respond to customer demand. This configuration is identical to products offered by Siemens (K173639) and GE Healthcare (K081091). The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat panel detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.

The equipment is intended to be used for the fluoroscopy/radiography diagnosis in hospital. The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications. The equipment is used for total patient population. The equipment is NOT intended to be used for Mammography screening. The equipment is NOT intended to be used for interventional procedure. The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations. Stored images in the equipment can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server. The Tomosynthesis option for the SONIALVISION G4 is intended to generate tomographic images of human anatomy including chest or extremities. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is not intended for mammographic applications

The Shimadzu SONIALVISION G4 is a universal X-ray RF system offering radiographic, fluoroscopic, angiographic and tomosynthesis techniques. Tomosynthesis technique is enabled by additional software option to the digital radiography system of the SONIALVISION G4. The Shimadzu SONIALVISION G4 is floor mounted table, and the system can be configured with Digital Radiography System, X-ray High Voltage Generator, Collimator and X-ray Tube. The purpose of this submission is to introduce an additional compatible digital x-ray receptor panel. This panel is manufactured by Canon. The panel was cleared by FDA for fluoroscopic use in K171194.

The RADspeed fit is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed fit enables radiographic exposure of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed fit uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The device is not intended for mammographic techniques. The indications for use remain the same as those for the predicate, except for the removal of tomographic technique.

The RADspeed fit is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed fit can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed fit consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. The X-ray generator of RADspeed fit has the capability to communicate with the digital radiography system to synchronize exposure timing, receive a code to select an anatomical program and to send X-ray technique factors and dose information after exposure.

The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The FDR Visionary Suite enables radiographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The FDR Visionary Suite uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/ trained professionals. The device is not intended for mammographic applications.

The FDR Visionary Suite is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The device can be used in a wide range of applications of digital radiography. The device consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support, collimator and digital radiography system. The system can be configured with radiographic table and/or radiographic stand as well. Optionally, the device is also used to perform tomosynthesis radiography by two different reconstruction modes, e.g. Filtered Back-Projection (FBP) mode and Shift-and-Add (SA) mode. SA reconstructed images are intended to be used alongside FBP reconstructed images and not for stand-alone diagnostic purpose.

The RADspeed Pro is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed Pro uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.

The RADspeed Pro is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed Pro can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed Pro consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. Optionally, the device is also used to perform tomosynthesis radiography by three different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. Iteration (IR) mode is used to reduce metal artifact in tomosynthesis image. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed. IR mode is recommended to reduce metal artifact.