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Processor VP-7000 The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and light source together with monitor, recorder and various peripheral devices. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis. Light Source BL-7000 The BL-7000 Light Source is used for endoscopic observation, diagnosis, treatment, and image recording, If is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices.

VP-7000 and BL-7000 are intended to be used in conjunction with Fujinon/FUJIFILM endoscopes for endoscopic observation, diagnosis, treatment, and image recording. The description for each of the components of the subject device is below: The VP-7000 Video Processor: The Processor relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. The Processor incorporates internal digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor provides for optional structural enhancement through user modes FICE. BLI. BLI-bright and LCI. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 100-240V/50-60Hz/0.8-0.5A. The Processor is housed in a steelpolycarbonate case measuring 390x110x485mm. The DK-7000E Keyboard is a standard accessory of VP-7000. It is used to enter pertinent procedural information (patient, physician, date, etc.) for display on the video monitor and digital/analog storage systems. The Keyboard is also used to control operational features of the VP-7000 Processor. The Keyboard resembles a standard computer keyboard, and is provided with an instruction label attached to it. The BL-7000 Light Source: The Fujinon/FUJIFILM endoscope employs fiber bundles to transmit light from the light source and subsequently to the body cavity. The Light Source employs 79.2W 4 LED lamps. Brightness control is performed by the user. The device is AC operated at a power setting of 100-240V/50-60Hz/1.2-0.7A. The Light Source is housed in a steel-polycarbonate case measuring 390x155x485mm.

The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 are intended to be used in combination with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and in diagnosis during endoscopic evaluation.

The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 are used with previously cleared ultrasonic endoscopes, EG-530UR2 & EG-530UT2 (K120446) and EB-530US (K121035) to provide ultrasonic images of the trachea, bronchial tree, and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation. The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 consist of two components, Processor and Keyboard, which are used in conjunction with one another. The SU-1 PLATINUM or SU-1 ultrasonic processors connect to an ultrasonic endoscope and transmit ultrasound waves into the body cavity by driving the transducer installed on the ultrasonic endoscope. The SU-1 PLATINUM or SU-1 ultrasonic processors process the reflected ultrasound signals received by the ultrasonic transducer in the body cavity and convert the electrical signals into image or video signals. The signals are displayed on the monitor or printer as ultrasonic images. The Keyboard, CP-1, is used to control operational features of the SU-1 PLATINUM or SU-1 ultrasonic processor. The Fuifilm ultrasonic processor SU-1 PLATINUM and SU-1 can acquire and display real-time ultrasound data in different modes such as M, B, Color Doppler, Pulse Doppler, Duplex and Triplex. Additionally. SU-1 PLATINUM offers a feature/mode known as Elastrography, which is a medical imaging modality that maps the elastic properties of the target organs. Relative stiffness of the tissue is visualized as a color distribution map by a way of calculating the distortion of the tissue caused by external compression of inner vibration, and displaying disparities in stiffness levels as different colors.

Diathermic Slitter (FlushKnife) DK2618J and DK2623J are intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The devices are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract. Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The device is indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.

The Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter) (the "devices") are electrosurgical instruments that remove tissue and control bleeding by use of high-frequency ("HF") electrical current. The devices are provided sterile for single-use only. The devices are provided in various models (described below), but each is comprised of the following major components: The FlushKnife and ClutchCutter consist of the following major components: - · Slitter Electrode at distal tip of the device that performs ablation, incision, dissection, avulsion, cauterization, coagulation, and hemostasis of tissue via delivery of HF electrical current. - Operation wire Inner wire of the device that connects the handle and slider control to the slitter, facilitates manual control of slitter position, and delivers the HF electrical current to the slitter. - · Tube Flexible resin tube that is inserted into body cavities and insulates operation wire carrying the HF electrical current. - Slider Portion of handle that extends and retracts the slitter portion from the distal end of the tube (FlushKnife) or opens and closes slitter jaws (ClutchCutter) by means of the operation wire. - · Handle Proximal end of the device that provides for user control. - · Active Cord ("A-Cord") Connector Used to connect the device to the electrosurgical power supply unit via an A-cord. The devices are comprised of a proximal handle with slider that is connected to a flexible resin tube. The flexible resin tube covers and insulates the operation wire and slitter (when retracted). The operation wire controls the mechanical function of and delivers HF electrical current to the slitter. The proximal end of the operation wire is connected to the slider, which allows the operator to manually control the extension of the slitter (for the FlushKnife) or open and close (ClutchCutter) of the slitter Jaws. The distal end of the operation wire connects to the slitter, which is located at the distal tip of the device. The devices connect to a HF electrosurgical power supply unit by an active cord ("A-Cord") connector. HF electrical current generated by HF electrosurgical power supply unit flows to the slitter from the HF electrosurgical power supply unit via the A-cord connector, and the operation wire. The distal tip of the device is inserted through the forceps channel of the specified endoscope. Once inserted, the operator can extend the slitter from the tip of the endoscope (FlushKnife) or opens and closes slitter jaws (ClutchCutter) using the slitter is extended to the target site of a patient. Cleavage, resection, incision, ablation, hemostasis, coagulation, or excision of tissue is achieved by delivering HF current to the target tissue through the slitter.

The FDR D-EVO GL flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatic exams wherever conventional film/screen or CR systems may be used. This device is used to capture anatomic regions that are too large for conventional CR/DR format sizes. FDR D-EVO GL is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Fujifilm's FDR D-EVO GL FPD System (DR-ID1300) is a digital detector system that interfaces with, and acquires and digitizes x-ray exposures from, standard radiographic systems. The DR-ID1300 is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults and pediatrics including longlength exams where anatomic regions that are too large for conventional CR/DR format sizes, such as the entire spine or lower extremities, can be captured. The DR-ID1300 employs a new DR detector with a large exposure area size of ~ 17 x 49 inches. The detector can be placed in an appropriate stand for upright exams.

The EPX-4400 and EPX-4400HD Digital Video Processors with FICE are used for endoscopic observation, diagnosis, treatment, and image recording. The devices are intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). The devices may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.

The EPX-4400 and EPX-4400HD Digital Video Processor with FICE and light source consist of three components used in conjunction with one another: The VP-4400/4400HD Video Processor, The XL-4400/4400HD Light Source, and The DK-4400E Keyboard. The Processor relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. The Processor incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor provides for optional structural enhancement at the user's option. Spectral and structural enhancements are achieved through proprietary software. The Light Source employs a 300W Xenon lamp with a 75W emergency back-up Halogen lamp. Brightness control is performed by the user. The Keyboard is used to enter pertinent procedural information (patient, physician, date, etc.) for display on the video monitor and digital/analog storage systems. The Keyboard is also used to control operational features of the VP-4400/4400HD Processor. Both EPX-4400 and EPX-4400HD contain FICE which is an image processing technology.

The Fujifilm Endoscopes: EG-530CT, EG-530D, EC-530DL, and ES-530WE have the following indications for use: Indications for Use (EG-530CT): The EG-530CT Endoscope: This device is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. Indications for Use (EG-530D): The EG-530D Endoscope: This device is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. Indications for Use (EC-530DL): The EC-530DL Endoscope: This device is intended for the lower digestive tract, soecifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Indications for Use (ES-530WE): The ES-530WE Endoscope: This device is intended for the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.

The endoscopes are comprised of three general sections: an insertion portion and an umbilicus. The operation section controls the angulation (up/down/left/ight) of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charged couple device (CCD) image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water, provide suction, and a forceps channel. The forceps channels are used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged to the video processor and the light source. The proposed models are used in combination with Fuilfilm's video processor, light source and peripheral devices (water tank, endoscope accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, and cart). The minor modifications to the endoscopes were made for the purpose of overall product enhancement and general technological advancement.

The Wireless/Wired FDR D-EVO II flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The FDR D-EVO II is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Fujifilm's FDR D-EVO II Flat Panel Detector System (DR-ID1200) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures from, standard radiographic systems. The FDR D-EVO II is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired/tethered data communication between the detector and the system. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. While maintaining Fujifilm's unique Irradiated Side Sampling (ISS) design delivering high image quality. FDR D-EVO II offers the new and improved 1200 series flat panel detectors with upgraded wireless feature, memory exposure mode, and extended image readout feature. Additionally, the 1200 series detectors are equipped with several changes: Rounded-edge design for easy handling, image compression algorithm for faster image transfer, improved internal circuit design for electronic noise reduction, new LED design for easy detector identification, extra protection against ingress of water, and antibacterial coating designed to maintain cleanness. Not only the 1200 series detectors' robust design enhances load-bearing characteristics, but also the powersaving designs combined with the new battery packs and charger improve battery performance. The weight of 1200 series detectors is less than that of 600 series.

This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm's endoscopy system.

The Fujifilm Endoscopic CO2 Regulator GW-100 supplies CO2 gas to insufflate the gastrointestinal tract and water to wash the endoscope lens during an examination. The GW-100 is similar to Olympus' XECR-2 Endoscopic Insufflation Unit. The scientific fundamental technology and operating principle of the subject and predicate devices are similar. Both devices utilize a solenoid/decompression valve mechanism to dispense CO2. CO2 can either be supplied from a CO2 gas cylinder or from a facility's main CO2 supply. The GW-100 can be used with any Fujnon/Fujifilm gastrointestinal endoscope, Fujinon/Fuiifilm Video Processor/Light Source system, video monitor, footswitch, cart, endoscopic accessories, electrosurgical unit and other peripheral devices used for endoscopy.

ASPIRE Bellus is intended to receive digital mammography images and to display these images on monitors for radiologists' review for diagnostic and screening purposes. To assist radiologists, ASPIRE Bellus provides functions such as image review, measurement, post-processing, film printing, displaying mammography CAD results, and image manipulation. ASPIRE Bellus does not accept lossy compressed mammographic images, which should not be used for primary diagnostic interpretation. Display monitors connected to ASPIRE Bellus for diagnostic interpretation of mammographic images must be cleared for use in digital mammography. All images sent to or imported into the ASPIRE Bellus must conform to regulatory requirements. Image quality must conform to applicable quality guidelines.

FUJIFILM's Mammography Viewer SMV658 (V3.0) system receives mammography images directly from FUJIFILM's digital mammography acquisition systems using DICOM protocol and PACS via network. These images are displayed on mammography diagnostic monitors for doctors' review. The SMV658 system works as mammography workstation depending on its configuration (monitors) and license information (software key). The system provides visualization and image enhancement tools (such as image review, measurement, postprocessing, film printing, displaying mammography CAD results, and image manipulation) to assist the radiologists' review of mammography images for diagnostic and screening purposes.

Synapse 3D Lung and Abdomen Analysis is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Lung and Abdomen Analysis accepts DICOM compliant medical images acquired from CT. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to Synapse 3D Base Tools, Synapse 3D Lung and Abdomen Analysis is intended to; - use non-contrast and contrast enhanced computed tomographic images of the lung, provide custom workflows and UI, and reporting functions for lung analysis including boundary detection and volume calculation for pulmonary nodules in the lung based on the location specified by the user, segmentation of bronchial tubes in the lung, approximation of air supply region by the user specified bronchial tube, identifying, displaying and processing low absorption regions in the lung. - use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D. - analyze a bronchus path to reach a lung nodule using the volume data collected with CT, and simulate insertion of bronchoscope into the path.

Synapse 3D Lung and Abdomen Analysis is the updated version of previously - cleared Synapse 3D Lung and Abdomen Analysis software (cleared by CDRH via K120648 on 06/14/2012). Synapse 3D Lung and Abdomen Analysis is used in addition to Synapse 3D Base Tools (K120361) to analyze the images acquired from CT. Synapse 3D Lung and Abdomen Analysis is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning of DICOM compliant medical images. Synapse 3D Lung and Abdomen Analysis is an application that performs the CT lung analysis/airway, lung analysis scope, and abdomen 2D and 3D fat analysis.