FDX Console (DR-ID300CL) Software

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 16, 2017 FUJIFILM Medical Systems USA, Inc. % Mr. Peter Altman Regulatory and Quality Consultant 419 West Avenue STAMFORD CT 06902 Re: K170451 Trade/Device Name: FDX Console (DR-ID300CL) Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 8, 2017 Received: February 15, 2017 Dear Mr. Altman: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. 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Sincerely yours, Michael O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### K170451 Device Name FDX Console (DR-ID300CL) Software Indications for Use (Describe) The FDX Console is a workstation intended to associate digital (CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. The FDX Console is not for use in Mammography. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------|-----------------------------------------| | <label>Prescription Use (Part 21 CFR 801 Subpart D)</label> | <input checked="true" type="checkbox"/> | | <label>Over-The-Counter Use (21 CFR 801 Subpart C)</label> | <input type="checkbox"/> | PLEASE DO NOT WRITE BELOW THIS LINE = CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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The logo is simple and modern, and the tagline conveys the company's commitment to providing value through innovation. # 510(k) Summary # FDX Console (DR-ID300CL) Software ## Date: February 8, 2017 ## Submitter's Information: FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA ### Contact Person: | Name: | Peter Altman | |------------|-----------------------------------| | Title: | Regulatory and Quality Consultant | | Telephone: | (203) 602-3576 | | Facsimile: | (203) 602-3785 | ### Identification of the Device: | Proprietary/Trade Name: | FDX Console (DR-ID300CL) Software | | | | |-------------------------|---------------------------------------------|-------|------------|----------------------------------------| | Classification Name: | Picture Archiving and Communications System | | | | | Regulations Number: | 21 CFR 892.2050 | | | | | Product Codes: | LLZ | | | | | Device Class: | Class II | | | | | Review Panel: | Radiology | | | | | Common Name: | Medical | Image | Processing | Workstation or Acquisition Workstation | ## Identification of the Legally Marketed Predicate Devices: - 1. FDR D-EVO Flat Panel Detector System (DR-ID600) with Improved Virtual Grid Software, K153464 cleared 4/8/2016 - 2. Fuji Medical CR Console, K041990, cleared 8/6/2004 ### DEVICE DESCRIPTION l. The FDX Console is used by a radiographer for viewing Digital Radiography (DR) and Computed Radiography (CR) images for final quality assurance (QA) checking and image processing and optimization prior to transferring the images to external devices such as a PACS or a printer. Furthermore, when connected to Fuji Image Readers via a network, the FDX Console is used to enter patient ID information, exposure information, and in the case of CR register Image Plate (IP) barcode numbers. The FDX Console is compatible with the ACR/NEMA DICOM Version 3.0 standard. The four primary features of the FDX Console are patient identification, exam selection, image processing, and image transmission. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in a bold, sans-serif font, with a red square above the "I" in "FUJIFILM". Below the logo is the tagline "Value from Innovation" in a smaller, sans-serif font. The logo is simple and modern, and the tagline conveys the company's commitment to innovation. - Patient Identification feature: Patient demographics can be manually . entered using a keyboard or captured from a RIS/HIS using DICOM Worklist Management. Also, a Touch screen monitor and barcode reader streamlines this data entry. - Exam Selection feature: Select the patient, select the applicable exam, for CR barcode the Imaging Plate (IP), and touch Start to select the exam or use the DICOM Worklist Management feature with Auto Exam Select. - . Image Processing feature: DR and CR Images are processed, displayed and reviewed prior to image transfer. - Image Transmission feature: Images are transferred to other medical imaging devices for softcopy viewing or storage devices for archiving or to a printer for hardcopy film output. #### INDICATIONS FOR USE .............................................................................................................................................................................. The FDX Console is a workstation intended to associate digital (CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. The FDX Console is not for use in Mammography. #### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS . The FDX Console is a software device based upon the predicate devices. The modifications implemented in Version 10.0 do not alter the technological characteristics of the predicates, i.e., software is installed on off-the-shelf computer hardware running Microsoft Windows operating systems. #### SUBSTANTIAL EQUIVALENCE IV. The FDX Console Version 10.0 Software is substantially equivalent to the following legally marketed device: | Legally Marketed Device | 510(k) # | Clearance Date | |------------------------------------------------------------------------------------|----------|----------------| | Fuji Medical CR Console Model Flash IIP | K041990 | 8/6/2004 | | FDR D-EVO FPD System (DR-ID600) (includes the<br>FDX Console Version 9.0 software) | K153464 | 4/8/2016 | The CR Console has been chosen as the predicate device because it is the FDX Console's predecessor and therefore the general design including software, GUI, features, and capabilities are extremely similar. One of the major differences is that the FDX Console has the capability to acquire and process images from all Fujifilm digital radiography system whereas the CR Console was limited to Computed Radiography only. The FDX Console version 9.0 software was cleared with the FDR D-EVO FPD System (DR-ID600) in K153464. It has exactly the same image processing software as the subject Version 10.0 device. The only differences are that FDX Console V10.0 will be able to use the Microsoft Windows 10 operating {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a small red square above the "I" in Fujifilm. Below the logo, the words "Value from Innovation" are written in a smaller font. system and that this submission introduces the SmartController and RemoteDesktop software capabilities allowing remote operation of the FDX Console. The following comparison applies: | | Subject Device | Predicate Device | Predicate Device | |-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | FDX Console (DR-<br>ID300CL) Software | FDX Console (DR-<br>ID300CL) With Virtual Grid<br>Software Option<br>for the FDR D-EVO FPD<br>system (DR-ID600)<br>(K153464 cleared<br>4/8/2016) | Fuji CR Console (Flash<br>IIP)<br>(K041990 cleared<br>8/6/2004) | | Indications<br>for Use<br>Indications<br>for use for<br>options | The FDX Console is a<br>workstation intended to<br>associate digital (CR<br>and/or DR) images with<br>patient and exam<br>information, apply image<br>processing to facilitate<br>diagnosis, display the<br>image, and output the<br>resulting image and<br>exam data for further<br>display, distribution, or<br>archiving. The FDX<br>Console is not for use in<br>Mammography. | The Wireless/Wired FDR D-<br>EVO flat panel detector<br>system is intended to capture<br>for display radiographic<br>images of human anatomy. It<br>is intended for use in general<br>projection radiographic<br>applications including<br>pediatric and neonatal exams<br>wherever conventional film<br>/screen or CR systems may<br>be used. The FDR D-EVO is<br>not intended for<br>mammography, fluoroscopy,<br>tomography, and angiography<br>applications.<br>The FDR D-EVO can be used<br>with Virtual Grid Software,<br>which is optional image<br>processing software installed<br>on Fujifilm's FDX Console.<br>Virtual Grid Software can be<br>used in lieu of an anti-scatter<br>grid to improve image<br>contrast in general<br>radiographic images by<br>reducing the effects of scatter<br>radiation. | The Fuji CR Console is a<br>CR modality workstation<br>intended to associate digital<br>FCR images (except<br>mammography images)<br>with patient and exam<br>information, apply image<br>processing to facilitate<br>diagnosis, display the<br>image, and output the<br>resulting image and exam<br>data for further display,<br>distribution, or archiving.<br>None. | | | None. | | | | | | Image Processing Characteristics | | | Spatial<br>Frequency<br>Processing | Yes | Yes | Yes | | Tonal<br>Conversion | Yes | Yes | Yes | | Dynamic Range<br>Control<br>Processing<br>(DRC) | Yes | Yes | Yes | | Tomographic<br>Artifact<br>Suppression<br>Processing<br>(TAS) | Yes | Yes | Yes | | Gradation<br>Processing | Yes | Yes | Yes | | Multi-Objective<br>Frequency<br>Processing | Yes | Yes | Yes | | | Subject Device | Predicate Device | Predicate Device | | | FDX Console (DR-<br>ID300CL) Software | FDX Console (DR-<br>ID300CL) With Virtual Grid<br>Software Option<br>for the FDR D-EVO FPD<br>system (DR-ID600)<br>(K153464 cleared<br>4/8/2016) | Fuji CR Console (Flash<br>IIP)<br>(K041990 cleared<br>8/6/2004) | | (MFP)<br>Flexible Noise | | | | | Control (FNC) | Yes | Yes | Yes | | Grid Pattern<br>Removal (GPR) | Yes | Yes | Yes | | Image<br>Automatic<br>Composition<br>Processing<br>(Image<br>Stitching) | Yes | Yes | Yes | | CoRrection<br>Filter (CRF) | Yes | Yes | No | | Image<br>processing<br>without<br>normalization | Yes | Yes | No | | Tomosynthesis<br>Option | Yes | Yes | No | | Dual Energy<br>Subtraction(DE<br>S) Option | Yes | Yes | No | | Virtual Grid<br>Option | Yes | Yes | No | | Improved<br>Virtual Grid<br>Software (VG2) | Yes | Yes | No | | Miscellaneous | | | | | Workstation<br>Software<br>Version | 10.0 | 9.0 | A11 | | Transfer<br>images to<br>PACS | Yes | Yes | Yes | | Enter Patient<br>info manually | Yes | Yes | Yes | | Enter Patient<br>info from RIS | Yes | Yes | Yes | | Select Exam | Yes | Yes | Yes | | Minimum<br>Basic<br>Computer<br>Configuration<br>(as provided in<br>US) | Model: HP ProDesk<br>600 G2 Series Small<br>Form Factor PC<br>Processor: Intel Core<br>i5-6500 with 3.2GHz<br>RAM: 4GB (4x1GB)<br>Hard Drive: 500GB<br>CD/DVD: Slim<br>SuperMulti DVD drive<br>Display: 17 " or 21"<br>color (touchscreen) | Model: Mini Tower<br>Processor: Core 2 Duo<br>RAM: 2GB<br>Hard Drive: 80GB<br>CD/DVD: DVD drive<br>Display: 17 " or 21" color<br>(touchscreen optional)<br>Monitor.<br>Accessories: Keyboard,<br>Mouse, Barcode scanner | Model:DELL Optiplex<br>GX260<br>Processor: Pentium 4,<br>3.06GHz<br>Hard Drive: 40GB<br>RAM: 512MB<br>Display: 17 " or 21" color<br>(touchscreen optional)<br>Monitor. | | | Subject Device<br>FDX Console (DR-ID300CL) Software | Predicate Device<br>FDX Console (DR-ID300CL) With Virtual Grid<br>Software Option<br>for the FDR D-EVO FPD<br>system (DR-ID600)<br>(K153464 cleared<br>4/8/2016) | Predicate Device<br>Fuji CR Console (Flash IIP)<br>(K041990 cleared<br>8/6/2004) | | | optional) Monitor.<br>Accessories:<br>Keyboard, Mouse,<br>Barcode scanner | | | | Operating<br>System | Windows 10/Windows<br>7 Professional 32-bit | Windows Vista/Windows 7<br>Professional 32-bit | Windows 2000<br>Professional | | Image<br>Transfer | Same as Predicates | Standard network<br>connectivity via DICOM<br>protocol & via Fuji DMS<br>Network | Standard network<br>connectivity via DICOM<br>protocol & via Fuji DMS<br>Network | | Remote<br>Operation<br>Capability of<br>Console | SmartController and<br>Remote Desktop | None | None | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in bold, black letters, with a red square above the "I". Below the word is the tagline "Value from Innovation" in a smaller font. The logo is simple and modern, and the tagline suggests that Fujifilm is a company that values innovation. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a small red square above the "I" in Fujifilm. Below the logo, the words "Value from Innovation" are written in a smaller, black font. #### V. SUMMARY OF STUDIES Non-clinical Performance Data: The FDX Console conforms to the following voluntary standards: | Standard | Title | |------------------|------------------------------------------------------------------------------| | DICOM, V3.0 2007 | Digital Imaging and Communications in<br>Medicine (DICOM) | | IEC 62304: 2006 | Medical Device Software – Software Life<br>Cycle Processes | | IEC 62366: 2014 | Medical devices – Application of usability<br>engineering to medical devices | As required by the risk analysis, all verification and validation activities related to the FDX Console were performed and the results were satisfactory. The verification and validation results are provided in the submission. Clinical Performance Data: Clinical studies were not required as there is no change in image processing. The substantial equivalence has been demonstrated by nonclinical studies. #### VI. CONCLUSION Based upon the supporting data summarized above, we concluded the FDX Console (DR-ID300CL) Software is as safe and effective as the legally marketed devices K041990 andK153464 and does not raise different questions of safety and effectiveness than the predicate devices.