Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration". October 24, 2017 Varex Imaging Corporation % Ms. Catherine Mulcahy Regulatory Affairs Manager 121 Metropolitan Drive LIVERPOOL NY 13088 ## Re: K172951 Trade/Device Name: Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 27, 2017 Received: September 28, 2017 Dear Ms. Mulcahy: 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. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Michael D. 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}------------------------------------------------ | PSC Pridelisting Services (39) + 4 3 +5 TAG.<br>ਜ ਤੋਂ | Program of Pr | PORT POR BORD (TITT) | |-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------| | | a sun<br>in bus respection of mility<br>and only and sund sund of engsteve of beterings at rollermonity of not only not emit rebrud ent<br>of the information collection; including suggestions for reducing this burgen, to:<br>"In a goeses my you condint on spenson's not a prospectived to respond to respond to, a collection of<br>"DO NOT SENIO YOUR COMPLETED FORM TO THE PRA STAFF EMALL ADDRESS BELOW.<br>This section applies only to requirements of the Papervork Recurciton Act of 1885.<br>informion unies it displays a syelaily valid OMB number.<br>Paperwork Reduction Act (PRA) Start<br>Food and Dug Administration<br>Department of Health and Human Services<br>PRAAStaff@fdda.frhs.gov<br>Office of Chief Information Officer | | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | D Over-The-Counter Use (21 CFR 801 Subpart C | Type of Use (Select one or both, as applicable)<br>2 Presscription Use (Part 21 CFR 801 Suppart D) | | | | ( / the survey pur syder some and munder and municipalism<br>pur sus and and and and sen of est rot tot tot tot top bebreatives under in the Mark of AC suxed xers' only | | | all | sension, segment mages over a regioned sind distributed interesses with a later printer. 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The logo consists of a stylized "V" made up of three vertical lines in different colors: dark blue, light yellow, and green. To the right of the "V" is the word "VAREX" in dark blue and green. Below "VAREX" is the word "IMAGING" in smaller, dark blue letters. # Section 3: 510(k) Summary | Date Prepared: | 9/25/17 | | |----------------------------------------------|-------------------------------------------|--| | Contact Person: | Catherine Mulcahv | | | | Regulatory Affairs Manager | | | Telephone: | 315-234-6853 | | | Fax: | 315-234-6801 | | | Submitter Name: | Varex Imaging Corporation | | | | 121 Metropolitan Drive | | | | Liverpool, NY 13088 | | | Subject Device | | | | Trade Name: | Nexus DR™ Digital X-ray Imaging System | | | | (with PaxScan 4343RC and PaxScan 4343Rv3) | | | Common Name: | Digital Radiographic System | | | Regulation: | 21 CFR 892.1680 | | | Classification Name: Stationary X-ray System | | | | Class: | II | | | Primary Product Code: MQB | | | #### Primary Predicate Device | Trade Name: | Nexus DR™ Digital X-ray Imaging System<br>(with Grid Suppression) | |-----------------------|-------------------------------------------------------------------| | Common Name: | Digital Radiographic System | | Regulation: | 21 CFR 892.1680 | | Classification Name: | Stationary X-ray System | | Class: | II | | Primary Product Code: | MQB | | 510(k) Number: | K171138 | ### Device Description: The Varex Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The Nexus DR™ Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform. The modified device consists of an X-ray imaging receptor, PaxScan 4343RC or PaxScan 4343Rv3, computer, monitor, and the digital imaging software. The Varex Nexus DR™ Digital X-ray Imaging System is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). The Nexus 121 Metropolitan Park Drive, Liverpool, New York 13088 Main Document - Section 3 - Page 1 of 7 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made of three vertical lines in different colors: dark blue, light yellow, and green. To the right of the "V" is the word "VAREX" in dark blue, with the "EX" in green. Below the word "VAREX" is the word "IMAGING" in smaller, dark blue letters. DR™ Digital X-ray Imaging System is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package. Like the predicate device, the modified Nexus DRTM Digital X-ray Imaging System is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image. Identical to the predicate device, the modified device is capable of interfacing with a PaxScan flat panel detector in vTrigger Mode or RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. The modified device also retains the ability to apply the grid suppression feature. However, the modified device is capable of interfacing with the Varex PaxScan 4343RC and PaxScan 4343Rv3 detectors. The main difference between the additional detector models is mechanical; the PaxScan 4343RC is a cassette-sized portable tethered version whereas the PaxScan 4343v3 is utilized in a fixed configuration. Through the use of a digital flat panel detector, and a non-integrated generator, the Nexus DR™ Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) is capable of acquiring digital radiographic images, processing and then displaying them in high quality for clinical diagnosis. The Nexus DR™ Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format. ### Indications for Use: The Varex Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR™ Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software. The Varex Nexus DR™ Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography). {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of the word "VAREX" in blue, with the "X" in green. To the left of the word is a stylized "V" made up of three lines in blue, yellow, and green. Below the word "VAREX" is the word "IMAGING" in smaller, blue letters. #### Technological Characteristics Comparison: The Nexus DR™ Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) supports the same modality as the predicate device with similar components or imaging concepts, has the same Indications for Use as the predicate device, and delivers equivalent image quality as the predicate device. The comparison chart below reveals that functions performed by the predicate device are performed by the modified device for the DR application. Therefore, the modified device is substantially equivalent to the predicate device. However, the modified device, Nexus DR™ Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3), has the additional ability to interface with the PaxScan 4343RC and PaxScan 4343Rv3 detectors in RAD Mode or vTrigger Mode with the grid suppression feature. Only minor modifications were necessary to provide the ability to interface with these additional detectors. All other features and functions remain unchanged. The Nexus DR™ Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) operating in RAD Mode (Panel Acquisition Mode) is designed to communicate with X-ray generators that provide Select, Prep and Request signals. The Nexus DR™ Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) utilizes an external I/O box to interface with compatible X-ray generators; not integrated. If an X-ray generator does not provide Select, Prep and Request signals, vTrigger Mode (AED) is used; thus no connection to the generator is required. | Feature/Item | Nexus DRTM<br>Digital X-ray Imaging<br>System (Grid<br>Suppression) | Nexus DRTM<br>Digital X-ray Imaging<br>System (PaxScan<br>4343RC, 4343Rv3) | |----------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------------| | Device Type | Predicate Device | Subject Device | | 510 (k) Number | K171138 | TBD | | Flat Panel<br>Detector | Varex<br>PaxScan 4336Wv4 | Varex<br>PaxScan 4343RC/<br>PaxScan 4343Rv3 | | Detector<br>Material | a-Si sensor array with<br>CsI or Gd2O2S:TB<br>scintillator | Same | | Detector<br>Dimensions | 17" x 14" | 17" x 17" | | Pixel<br>Size | 139 x 139 microns | Same | | Detector Element<br>Matrix | 3072 x 2560 | 3072 x 3072 | | Dynamic<br>Range | 16 bits | Same | | QVAL<br>(Uniformity) | 14.1 +/- 3.8 | 17.3 +/- 4.2 | ## Comparison Chart: 121 Metropolitan Park Drive, Liverpool, New York 13088 Main Document - Section 3 - Page 3 of 7 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for Varex Imaging. The logo consists of the word "VAREX" in blue, with the word "IMAGING" in smaller letters underneath. To the left of the word "VAREX" are four vertical lines, three of which are blue and one of which is yellow. The logo is simple and modern, and it is likely used to represent the company's brand. | Spatial<br>Resolution | 3.2 lp/mm | Same | |------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------| | Modulation<br>Transfer Function | 0.9 @ 1 cycle/mm<br>0.25 @ 2 cycles/mm<br>0.17 @ 3cycles/mm | 0.55 @ 1 cycle/mm<br>0.27 @ 2 cycles/mm<br>0.14 @ 3cycles/mm | | Detective<br>Quantum<br>Efficiency | 0.58 @ 1 cycle/mm<br>0.43 @ 2 cycles/mm<br>0.26 @ 3 cycles/mm | 0.55 @ 1 cycle/mm<br>0.43 @ 2 cycles/mm<br>0.30 @ 3 cycles/mm | | External<br>Connectivity | DICOM<br>3.0 Compatible | Same | | Operator<br>Console | Graphical User<br>Interface | Same | | Image<br>Processor | Intel CPU Based PC | Same | | Image<br>Storage | Hard Drive | Same | | Operating<br>System | Windows 10 | Same | | Image Acquisition<br>Cycle Time | 12 seconds | 9 seconds | | Power<br>Requirements | 110/120V,<br>230/240V,<br>50/60 Hz | Same | | Grid<br>Suppression | Yes | Same | | Panel Acquisition<br>Mode | vTrigger<br>or RAD Mode | Same | | Generator<br>Interface | Applicable* | Same | * Generators meeting these requirements can be interfaced with the Nexus DR™ Digital X-ray Imaging System (with PaxScan 4343RC or PaxScan 4343Rv3) in RAD Mode. - -The Generator/Handswitch/Console shall (allow the user to) provide Select, Prep and Request radiographic exposure signals in the form of digital signals. - The Generator shall be capable of accepting Expose signals available as relay outputs. For example, the following generators are capable of interfacing with the Nexus DR™ Digital X-ray Imaging System in RAD Mode. | Manufacturer | Model | |--------------|----------------| | Bennett | HFQ-1250P | | Bennett | HFQ-1000 | | CGR | Prestilix 1600 | | CPI | CMP200 | | CPI | Indico 100 | | CPI | IQ | | CPI | Millennia | 121 Metropolitan Park Drive, Liverpool, New York 13088 Main Document - Section 3 - Page 4 of 7 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is the logo for Varex Imaging. The logo consists of the letter V, which is made up of three vertical lines in different colors: blue, yellow, and green. To the right of the V is the word "VAREX" in blue. Below the word "VAREX" is the word "IMAGING" in a smaller font size, also in blue. | Continental | TM | |------------------|--------------| | DELL | ATC 525 | | DELL | MP-500 | | DELL | ATC 725 | | Electromed | All Series | | EMD | Epsilon | | Gendex | ATC 525 | | General Electric | MVP | | General Electric | MPS | | Holigic | TM | | IMD | Atlas 100-30 | | Gendex | ATC 725 | | K&S Rontgenwerks | HFe | | Philips | Optimus 80 | | Picker | Convix | | Picker | MTS | | Picker | Synergen | | Quantum | Odyssey | | Sedecal | HF | | Sedecal | SHF | | Shimadzu | UD150-10 | | Siemens | Polydoros 80 | | Siemens | Polydoros IT | | Summit | Innovet | | Spellman | HFE | | Toshiba | KX080 | | Trex | TM | | Universal | MP-500 | ### Non-clinical Tests Discussion: Non-clinical Data submitted is consistent with FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" available at the website http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc eDocuments/ucm073781.pdf. Validation was completed in accordance with the Validation Protocols included with this submission. Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the Nexus DR™ Digital Xray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) is as safe and {8}------------------------------------------------ effective as the predicate devices and does not raise different questions of safety and effectiveness. #### Clinical Tests Discussion: Clinical images were not necessary to establish substantial equivalence based on the modifications to the device (the PaxScan 4343RC and PaxScan 4343Rv3 Flat Panel Detectors use identical technology as the predicate device image detector), and bench testing results provide enough evidence that the subject device works as intended. #### Standards and Guidance Documents: #### Electrical Safety and EMC Standards The modified device conforms to these consensus standards and has passed all relevant required testing: - AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2 Edition 3: 2007-03: Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (2007) ### Data Storage and Exchange Standards The Nexus DR™ Digital X-ray Imaging System is designed to meet American College of Radiology / American College of Cardiology / National Electrical Manufacturers Association DICOM, Version 3.0, Parts 1 through 8, Part 10 (Media Storage and File Formats), Part 11 (Media Storage Applications Profiles) and Part 12 (CD-R Annex): - NEMA PS 3.1 3.20; Digital Imaging and Communications in Medicine ● (DICOM) Set (2011) ### Radiation Control The Nexus DR™ Digital X-ray Imaging System meets the requirements of the Radiation Performance Standards of 21 CFR Subchapter J. applicable Sections 21 CFR 1020.30. 1020.31 and 1020.32. Any video monitors chosen for this application meet the requirements of the Radiation Performance Standards of 21 CFR Subchapter J, applicable Section 21 CFR 1020.10. Optical disk storage devices (reader and writer) comply with Radiation Performance Standards of 21 CFR Subchapter J, applicable Section 21 CFR 1040.10. ### Guidance {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of the letter V, which is made up of three vertical lines in different colors. The first line is dark blue, the second line is yellow, and the third line is green. To the right of the letter V is the word "VAREX" in dark blue, and below that is the word "IMAGING" in smaller letters. The following guidance documents were considered and utilized in the development of the modified device. Applicable identified requirements derived from these guidance documents have been met. - Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices ● - How to Prepare a Special 510(k) ● - Guidance for Content of Premarket Submissions for Software Contained in ● Medical Devices - Deciding When to Submit a 510(k) for a Change to and Existing Device ● - Pediatric Information for X-ray Imaging Device Premarket Notifications - Applying Human Factors and Usability Engineering to Medical Devices - . Use of Symbols in Medical Device Labeling - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Refuse to Accept Policy for 510(k)s ● - eCopy Program for Medical Device Submissions - Global Unique Device Identification Database (GUDID) ● ### Conclusion: Based upon the results of Verification and Validation testing, the Nexus DR™ Digital Xray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) has no new indications for use, has no significant technological differences, and is as safe and effective as, does not raise different questions of safety and effectiveness and is therefore substantially equivalent to the above listed current legally marketed predicate device.