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Fuji Computed Radiography Mammography Suite (FCRMS) ESSENTIAL PRESCRIBING INFORMATION PRESCRIPTION DEVICE Caution: Federal Law R

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Fuji Computed Radiography Mammography Suite (FCRMS) ESSENTIAL PRESCRIBING INFORMATION PRESCRIPTION DEVICE Caution: Federal Law R Fuji Computed Radiography Mammography Suite (FCRMS) ESSENTIAL PRESCRIBING INFORMATION PRESCRIPTION DEVICE Caution: Federal law restricts this device to sale by or on the order of a physician. DEVICE DESCRIPTION machine In conventional screen-film mammography (SFM), a mammographic x-ray receptor exposes the breast and projects an aerial x-ray intensity image onto a screen-film Radiography which is then processed to produce an analog image. The Fuji Computed the screen- (FCR) system with FCRMS installed (FCRm) and a display device replaces film receptor and chemical processing system to produce a digital image. devices FCRm should be used with mammographic x-ray machines and output display for primary that are cleared by the United States Food and Drug Administration (FDA) are: image interpretation in mammography. The requirements for these components Mammographic X-ray Machine in the United An x-ray machine specifically designed for mammography and legally sold States for mammography should be used. filter x-ray tube should have as a minimum a molybdenum target and molybdenum The any of (Mo/Mo) combination for calibration of the FCRm image reader and optionally with rhodium the following anode target and filter combinations: molybdenum target target with filter (Mo/Rh), rhodium target with rhodium filter (Rh/Rh), and tungsten rhodium filter (W/Rh). exposure The x-ray system should have both manual exposure control and automatic and kVp, or control (AEC). The AEC may be of the type controlling mAs only, or mAs mAs, kVp and filter, or mAs, kVp, filter, and target. Fuji Computed Radiography System FCRm consists of the following: * Fuji dual-side Imaging Plates HR-BD in 18cm x 24 cm or 24cm x 30 cm sizes, for capturing the x-ray images and a corresponding number of Fuji IP Cassettes DM in the same sizes, for transporting the imaging plates; * a Fuji ClearView image reader configured for dual-side reading and 50 plate in micrometer sampling pitch; for reading the x-ray image from the imaging the cassette; and * a Fuji Flash Plus TIP CR console unit, the "acquisition" workstation with FCRMS installed. Page 1 of 22 Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information console unit may be With FCRMS installed in the Flash Plus lip CR console unit, the referred to as a Fuji Flash Plus I1Pm (appending an italic m for mammography). m appended to the Similarly, a connected image reader may be labeled with an italic reader. A complete model name, e.g., a Fuji ClearView CSm or ClearView Im image ClearView m FCRm system for mammography (HR-BD imaging plates, DM cassettes, Flash Plus I1Pm reader (for example ClearView CSm, ClearView I m, or other), and console) is also known as an FCRm system. Softcopy or Hardcopy Display on a: Primary interpretation of softcopy images must be performed either cleared * review work station consisting of a PC-based computer with FDA mammography displays capable of handling DICOM MG "for presentation" images; or of * Fuji review workstation with FDA cleared mammography displays capable handling DICOM MG "for presentation" or "for processing" images. with a minimum The review workstation should have a minimum of two displays, each image array size of five megapixels. for mammography For primary interpretation of hardcopy images, use a printer cleared pixel pitch of 50 supports DICOM basic grayscale print management service with a that 3.6. micrometers or less and film maximum optical density of at least INDICATIONS FOR USE is a software device The Fuji Computed Radiography Mammography Suite (FCRMS) forms the Fuji in conjunction with a specified Fuji Computed Radiography system that, with a dedicated Computed Radiography for mammography (FCRm) device. FCRm that can be used mammographic x-ray machine generates digital mammographic images in the same clinical for screening and diagnosis of breast cancer. It is intended for use systems. The applications as traditional screen-film based mammographic (SFM) using either hardcopy mammographic images can be interpreted by a qualified physician film or softcopy display at a workstation. CONTRAINDICATIONS There are no known contraindications. WARNINGS AND PRECAUTIONS Cautions and Warnings in theFCRm User Guide: Warnings: * For U.S. only: Until an accreditation body has been approved to accredit the of an unit, FDA will continue its process for extending the certification FCRm notified already certified facility to include these specific units. Until otherwise Page 2 of 22 30 Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information by FDA, a facility with an FCRm unit (that does not have a corresponding approved accreditation body) will be exempt from the MQSA accreditation to cover its requirement but must request FDA to extend its current certification unaccredited FCRm unit. be * The mammographic x-ray system's automatic exposure control (AEC) should calibrated for use with FCRm prior to use. that is • The FCRm image reader must be calibrated with S value in mammography a based on an exposure to the imaging plate of 20 mR at 25 kVp using only air in the molybdenum (Mo) target and Mo filter (Mo/Mo 0.03 mm) with beam. * The x-ray system must have a molybdenum (Mo) target and Mo filter for S value calibration. mechanical * Insertion of a broken cassette into an FCRm reader can result in failure and system shutdown. Cautions: with x-ray *FCRm does not emit radiation; however, it is used in conjunction with the emitting equipment. Refer to the Cautions and Warnings associated x-ray emitting equipment. · Do not use the Fuji reader and console in the presence of a flammable anesthetic or gaseous mixtures. * The user should follow the x-ray exposure unit instructions in order to safely operate the exposure device. * Do not use the Flash Plus liP Computer Radiography (CR) console for primary interpretation of patient images. The site is *Only authorized, trained personnel should operate this equipment. are responsible for ensuring that proper operating techniques and procedures followed when operating the FCRm. to * The softcopy review station should be located in a suitably dark environment measured at the enhance image visibility during review. The ambient light level, not exceed 20 surface of the monitor screen (with the monitor turned off), should lux. * DO NOT remove any covers or attempt to service the system. The system contains no user serviceable parts. media. * Do not touch t-e recording surface of magnetic or optical storage review station * Do not add unauthorized software to the CR console or soft copy or cause computers. Unauthorized software may affect system performance conflicts with system operation. Page 3 of 22 _3/ Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information necessary, remove the DO NOT insert a moist cassette into the CR reader. If the imaging plate is dry) imaging plate from wet cassette and insert it (make sure into a dry cassette. for mammography. * Only use the HR-BD Imaging Plate and Fuji IP Cassette DM the imaging plates. * Do not use water, screen cleaner, or isopropyl alcohol to clean cleaning of an imaging Anhydrous ethanol is the only solution suitable for wet plate. of * A protective, plastic bag should be used to cover the cassette in the presence blood or other body fluids. * Always follow the facilities' infection control guidelines. or any * Always wear appropriate protective clothing when handling blood cleaning solutions. should be cleaned and Equipment contaminated with blood or other body fluids disinfected with the appropriate agents. ensure that imaging plates * In a fixed site or mobile environment, after exposure, quality. are read without undo delay to preserve optimal image Manual: Cautions and Warninms in the FCRm Quality Control Cautions: for mammographic * Use only the Fuji IP Cassette DM and Fuji IP HR-BD imaging and QC testing. and QC tests, * Perform the Sensitivity Conformation test prior to the Acceptance filter at 25kVp. Do not using only molybdenum (Mo) target and Mo 0.03 mm cause an error in use any additional filter as the use of another filter may sensitivity confirmation. the lowest MR * If the mammography x-ray unit will not allow 20 mR exposures, 25 kVp for the sensitivity exposure greater than 20 should be used. Always use confirmation test. Page 4 of 22 Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information POTENTIAL ADVERSE EFFECTS FCRm: The following potential adverse effects that apply to mammography using * excessive breast compression; * excessive x-ray exposure; * electrical shock; * infection and skin irritation; or * abrasion or puncture wound SUMMARY OF NON-CLINICAL STUDIES Sensitometric Response by exposing The sensitometric response of the Fuji HR-BD imaging plate was assessed imaging with representative plates to x-ray beams with spectra typical of mammographic processing was a polymethylmethacrylate (PMMA) phantom in the beam. No image The pixel values obtained from the central region of the images were performed. in this case for recorded (see Figure 1). QL is the variable name used for the pixel value, an unprocessed image. ,-,2,500 04 QL( 11 bit) with 40mam PMMA ....! QL(1 lIbit) with 70mm PMMA ~1,5000--21000 _ _ ~1,500 ,000 ux500 C / 0 ----- ----- 1.OOE-01 1.00E+00 1.00E+01 1.00E+02 1.00E+03 ex pnslre(mR) Figure 1. Sensitometric Response of Imaging Plate Page 5 of 22 335 Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information Spatial Resolution of FCRMS The spatial resolution of the HR-BD imaging plate with the image processing x-ray was measured by imaging contrast transfer function phantoms with mammographic Transfer spectra. The Modulation Transfer (MTF) was calculated from the Contrast along with MTF Function (CTF) data. The results for processed and unprocessed images for a SFM system are shown in Figure 2.
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