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The FUJIFILM Bronchoscope Model EB-530P is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

The FUJIFILM Bronchoscope Model EB-530P is comprised of three general sections: a control/ operating section, an insertion and an umbilicus. The control/operating section controls the angulation (up/down) of the distal end of the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary charged coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion 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 umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The subject device is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K122535.

SP-900: The FUJIFILM Ultrasonic Processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation. PB2020-M: This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities.

The FUJIFILM Ultrasonic Processor SP-900 and Ultrasonic Probe PB2020-M consists of five components: 1) processor (SP-900), 2) probe (PB2020-M), 3) control pad (CP-900), 4) scanner (RS-900), and 5) power cord. The SP-900 generates ultrasound waves into the body cavity by driving the ultrasonic transducer installed in the PB2020-M, which is inserted through the forceps channel of an endoscope. The SP-900 processes the reflected ultrasound signals which the PB2020-M receives in the body cavity and further converts the processed electrical signals into video signals to relay to a monitoring system. The SP-900 can acquire and display real-time ultrasound data in B-mode. The CP-900 is used to control operational features of the RS-900 provides the mechanical scanning for acquiring a two-dimensional image. The power cord supplies power to the SP-900.

The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.

The ASPIRE Cristalle (K133972) (FDR MS-3500) is an integrated FFDM system combining an X-ray system made by Fujifilm with Fujifilm's a-Se detector and FDR-AWS3000 acquisition workstation (AWS). The system creates digital mammography images by direct capture of x-ray energy using a detector of Fujifilm design utilizing an a-Se photo-conversion layer with TFT readout circuitry to acquire image data and transfer images to the AWS for automated post processing, technologists' preview and QC, and subsequent transmission to hard copy printers, diagnostic workstations and archiving systems. The ASPIRE Cristalle provides powered compression and AEC modes. The subject of this premarket notification is a software upgrade to the predicate device. The hardware is unchanged. The software is unchanged with the exception that the subject device incorporates improved grayscale and frequency processing software named Dynamic Visualization II for Mammography (DVIIm) in the FDR-AWS3000 image acquisition software. DVIIm image processing consists of EDR2m and MFP2 image processing. - . Exposure Data Recognition 2 for mammography (EDR2m) = the EDR2m algorithm analyzes image data and identifies various anatomic structures using a statistical estimation method as opposed to original EDR's histogram analysis method. EDR2m determines the parameters to optimize brightness and contrast of the image based on the analysis result. - . Multi-Object Frequency Processing 2 (MFP2) - MFP2 optimizes the brightness, contrast and sharpness of the image using parameters determined by the EDR2m processing. MFP2 uses additional low frequency tables and a combination of automatic and preset dynamic range control operations. DVIIm takes full advantage of the wide range of image data acquired with the high sensitivity of Fujifilm's advanced detector technologies. DVIIm provides improved contrast and density stability throughout the entire exposure region and achieves improved visibility across a wide range of breast compositions including the presence of implants.

ASPIRE Bellus II is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting. This product accepts DICOM compliant medical images acquired from a variety of imaging devices including, MG, CT, PT, MR, CR, DX, and US, etc. This product also provides general 2D/3D viewing and general image processing, measurements, annotations, reporting, printing, storing, and general image administration tools, etc. This product does not accept lossy compressed mammographic images, which should not be used for primary diagnostic interpretation. Display monitors connected to this product for diagnostic interpretation of mammographic images must be approved for use in digital mammography. All images sent to or imported into this product must conform to regulatory requirements. Image quality must conform to applicable quality guidelines.

ASPIRE Bellus II is medical application software with speedy image display and intelligent functions by image processing technologies. This application can support user to efficiently perform interpretation of examination images and make a diagnosis using various modality images and generate Mammography reports for diagnostic/screening purposes. ASPIRE Bellus II can receive various diagnostic images directly from image acquisition systems or PACS via network using DICOM protocol. Images are displayed on viewer monitors for doctors' review.

The Fujifilm Duodenoscope Model ED-530XT is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

The Fujifilm Duodenoscope Model ED-530XT is comprised of three main sections: an operation section, an insertion portion, and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion portion contains glass fiber bundles, several channels and a CCD image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water and provide suction, as well as a forceps channel. The forceps channel is 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 in to the video processor and the light source.

Dynamic Visualization II Image Processing is an optional software for the FDX Console, intended to provide optimized image quality over a wide range of patient thicknesses, especially for bariatric imaging. The device is not intended for mammography use.

Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures, from standard radiographic svstems. The FDR D-EVO 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 exams. The Acquisition Workstation for the DR-ID600 is the FDX Console. Dynamic Visualization II Image Processing (DVII) is optional software included in v9.0 of the FDX Console. The FDX Console and Dynamic Visualization II software may be used with Fujifilm DR and CR X-ray systems. Dynamic Visualization II is an enhanced version of Fujifilm's Dynamic Visualization™ (DV) image processing software. The enhancements made to DVII are designed to provide optimized image quality over a wide range of patient thicknesses, and can be particularly useful when imaging bariatric patients. DVII uses the same image processing sequence as the predicate DV, but the EDR (Exposure Data Recognition) and MFP (Multi-objective Frequency Processing) algorithms have been modified. When compared to the current EDR and MFP algorithms, the corresponding new algorithms (EDR2, MFP2) have been modified as follows: EDR2 - to identify and optimize various anatomic structures in an acquired image prior to the subsequent application of contrast and sharpness image processing steps, EDR2 uses a feature recognition method as opposed to conventional EDR's histogram analysis method. MFP2 - similar to MFP, MFP2 sharpens and balances contrast in anatomic structures in an image after being subject to Exposure Data Recognition. MFP2 uses additional low frequency tables and a combination of automatic and preset dynamic range control operations.

The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endscopic procedures such as mucosal resection. The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are comprised of three main sections: an attaching portion, a distal portion, and a drain portion. The attaching portion is a wider diameter opening which is used to connect the hood to an applicable endoscope; a distal portion is the ending portion of the hood which tapers into narrower diameter opening, the drain slits on the distal portion form drain portion which prevent the fluids lodging on the surface of the endoscope. The subject devices are used in combination with their respective applicable Fujifilm's endoscopes as shown in the table 7.1. All the applicable endoscopes marketed in USA are cleared under respective 510(k) notices.

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, coagulation and hemostasis of tissue within the digestive tract.

Diathermic Slitter (FlushKnife) is sterile and intended for single used electrosurgical instruments that remove tissue and control bleeding by use of high-frequency ("HF") electrical current. The device is 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 high frequency (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 and retraction of the distal end of the operation wire connects to the slitter, which is located at the distal tip of the device. The device connects to a HF electrosurgical power supply unit by an active cord ("A-Cord") connector. HF electrical current generated by a HF electrosurgical power supply unit flows to the slitter from the HF electrosurgical power supply unit via the A-cord, 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 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 device is provided sterile for single-use only. The device can supply sterile water or fluids to its distal end target site via a water/fluid supply channel. The port for the water/fluid supply channel is located on the handle at the proximal end of the device. The sterile water or fluid also aids in the removal of debris, blood and extraneous material from the distal end of the device or a target site. To supply sterile water or fluid to the distal end target site, a syringe filled with water or fluid is connected to the water/fluid inlet at the proximal handle. Besides a syringe, alternate delivery methods can also be used to supply sterile water or fluid to the distal end target site of the device.

The FDR AQRO (DR-XD 1000) is a digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. The FDR AORO is not intended for mammography.

FUJIFILM's FDR AQRO (DR-XD1000) is a compact, economical, lightweight, nonmotorized, low power (2.5 kW), mobile X-ray system designed to work with FUJIFILM's GOS and Csl scintillator FDR D-EVO2 (DR-ID 12XXSE) family of digital X-ray detectors coupled. The D-EVO2 detectors received clearance on 7/23/2014 via 510(k) K142003. The FDR AQRO includes a built-in operation console. The AQRO's console uses Version 10.0 of Fujifilm's FDX Console Software. This software received 510(k) clearance via K170451 on 3/16/2017. The console software includes Virtual Grid 2 (VG2) Image Processing functionality. The VG2 function allows using the mobile X-ray system without a physical grid, resulting in a dose reduction of up to 50% (when compared to using a physical grid). The Virtual Grid 2 Image Processing software received clearance on 4/8/2016 via K153464. The reduction in the external dimensions of FDR AQRO enables smooth movement in the hospital and at the bedside because of an integrated X-ray tube and high-voltage generator (mono-block) that eliminates the need for High Voltage cables and utilizes less space. A high performance Li-ion battery provides up to twelve (12) hours of continuous use (at ~20 exposures/hour) with a quick full charge in four hours. A quick charge of 15 minutes provides one hour of usage. Exposure may also be made when the AC power cord is plugged in.

Synapse 3D Perfusion 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, and treatment planning. Synapse 3D Perfusion Analysis accepts DICOM compliant medical images acquired from CT and MR. 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 Perfusion Analysis provides the parameter images by post-processing of dynamic scanned CT arteriography and magnetic resonance (MR) images acquired with contrast agents to aid the assessment of cerebral (CT and MR), myocardial (CT) and abdomen (CT) blood flows. The parameter images are Blood Volume (BV), Blood Flow (BF), Mean Transit Time (MTT), and Time To Peak (TTP),

Synapse 3D Perfusion Analysis is medical device software for Perfusion Analysis that provides the parameter images by post-processing of dynamic scanned CT arteriography and MR images acquired with contrast agents to aid the assessment of cerebral (CT and MR), myocardial (CT) and abdomen (CT) blood flows. The parameter images are Blood Volume (BV), Blood Flow (BF), Mean Transit Time (MTT), and Time to Peak (TTP). The perfusion parameter images can be presented to the trained medical professionals as the time-density curves (TDC) and perfusion characteristics maps (in parametric and summary) to assist them in assessing the blood flows. Synapse 3D Perfusion Analysis includes the following perfusion analysis applications. - (1) Brain Perfusion (CT and MR) (unchanged from the FDA-cleared version K120637) is an application that analyzes the cerebral blood flow using the contrast-enhanced dynamic scanned CT and MR cerebral arteriography images. The Brain Perfusion post-processes the cerebral arteriography CT and MR images, and generates the parameter images of Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), MTT, and TTP. - (2) 4D Perfusion (CT) is an application that analyzes the changes in the cerebral blood flow over time (in 4D) using the contrast-enhanced multi-phase 3D whole-brain images. The 4D Perfusion post-processes the cerebral arteriography CT and MR images, and generates the 4D (over time) parameter images of CBV, CBF, MTT, and TTP. - (3) Abdominal Perfusion (CT) is an application that analyzes the blood flow of abdominal organs over time (in 4D) using the contrast-enhanced multi-phase 3D abdomen images. The Abdominal Perfusion post-processes the abdominal CT images, and generates the parameter images of Tissue Blood Volume (TBV), Tissue Blood Flow (TBF), MTT, and TTP. - (4) Cardiac Perfusion (CT) is an application that analyzes the myocardial blood flow using the multi-phase 3D heart images. The Cardiac Perfusion post-processes the contrast-enhanced Myocardial CT images, and generates the parameter images of Myocardial Blood Volume (MBV), Myocardial Blood Flow (MBF), MTT, and TTP. Synapse 3D Perfusion Analysis runs on Windows standalone and server/client configuration installed on a commercial general-purpose Windows-compatible computer. Synapse 3D Perfusion Analysis is an optional software module that works with Synapse 3D Base Tools (cleared by CDRH via K120361 on 04/06/2012) which is connected through DICOM standard to medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medical devices, and it retrieves image data via network communication based on the DICOM standard. The retrieved image data are stored on the local disk managed by Synapse 3D Base Tools, and the associated image-related information of the image data is registered in the database and is used for display, image processing, analysis, etc. The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer.