Nexus DR Digital X-ray Imaging System
Device Facts
| Record ID | K171138 |
|---|---|
| Device Name | Nexus DR Digital X-ray Imaging System |
| Applicant | Varex Imaging Corporation |
| Product Code | MQB · Radiology |
| Decision Date | May 17, 2017 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
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).
Device Story
System acquires digital X-ray images using PaxScan 4336Wv4 flat panel detector; converts X-rays to visible light via scintillator, then to digital signal via TFT array. Operates in vTrigger (AED) or RAD mode (via external I/O box interfacing with X-ray generators). Software processes images, including new grid suppression feature to detect/remove line artifacts from anti-scatter grids. Used in clinical settings by operators to acquire, display, and export images via DICOM to PACS or printers. Enhances diagnostic detail; facilitates clinical decision-making by providing high-quality digital radiographs. Benefits patient through improved image quality and potential for reduced retakes.
Clinical Evidence
No clinical data. Substantial equivalence established via bench testing and validation protocols consistent with FDA guidance for solid-state X-ray imaging devices. Bench testing confirmed performance metrics (SNR, MTF, DQE, sensitivity) are equivalent to the predicate.
Technological Characteristics
Digital radiographic system; a-Si sensor array with CsI or Gd2O2S:TB scintillator; 17" x 14" detector; 139-micron pixel size; 16-bit dynamic range. Connectivity: DICOM 3.0. Software: Windows 10-based PC. Grid suppression algorithm implemented in software. Sterilization: N/A. Electrical safety: AAMI ANSI ES60601-1, IEC 60601-1-2.
Indications for Use
Indicated for general radiographic examinations and applications, excluding fluoroscopy, angiography, and mammography. Intended for use in multipurpose or dedicated clinical settings to replace conventional film or existing digital systems.
Regulatory Classification
Identification
A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- Nexus DR™ Digital X-ray Imaging System (with PaxScan 4336Wv4) (K161459)
Submission Summary (Full Text)
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2017
Varex Imaging Corporation % Ms. Catherine Mulcahy Regulatory Affairs Manager 121 Metropolitan Drive LIVERPOOL NY 13088
Re: K171138 Trade/Device Name: Nexus DR" Digital X-ray Imaging System (with Grid Suppression) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: April 17, 2017 Received: April 18, 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-
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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.
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 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. 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 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
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# Indications for Use
510(k) Number (if known)
#### K171138
#### Device Name
Nexus DRTM Digital X-ray Imaging System (with Grid Suppression)
#### Indications for Use (Describe)
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 dedications 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).
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" 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, with the "X" in green. Below "VAREX" is the word "IMAGING" in smaller, blue letters.
# Section 3: 510(k) Summary
| Date Prepared: | 5/5/17 | |
|---------------------------|-------------------------------------------------|--|
| Contact Person: | Catherine Mulcahy<br>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 DRTM Digital X-ray Imaging System | |
| | (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 | | |
| | | |
#### Primary Predicate Device
| Trade Name: | Nexus DR™ Digital X-ray Imaging System<br>(with PaxScan 4336Wv4) |
|-----------------------|------------------------------------------------------------------|
| 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: | K161459 |
## 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. Varian PaxScan 4336Wv4, 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
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Image /page/4/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of three vertical lines, with the first line being blue, the second line being yellow, and the third line being green. To the right of the "V" is the text "VAREX" in blue, and below that is the text "IMAGING" in a smaller font size.
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 DR™ 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 the same wireless PaxScan 4336Wv4 flat panel detector in vTrigger Mode.
However, the modified device is also capable of operating in RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. Through the use of a digital flat panel detector, and a non-integrated generator, the Nexus DR™ Digital X-ray Imaging System (with Grid Suppression) 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.
Anti-scatter grids play an important role for enhancing image quality in radiography by transmitting a majority of primary radiation and selectively rejecting scattered radiation. When anti-scatter grids are utilized by the end user, the modified device includes an additional feature that can detect and suppress the line artifacts caused by these grids.
## 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).
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Image /page/5/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of three vertical lines, with the left line being blue, the middle line being yellow, and the right line being green. To the right of the "V" is the word "VAREX" in blue, and below that is the word "IMAGING" in smaller, gray letters.
#### Technological Characteristics Comparison:
The Nexus DR™ Digital X-ray Imaging System (with Grid Suppression) 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 Grid Suppression), has the additional ability to interface with the Varian PaxScan 4336Wv4 wireless detector in RAD Mode with a new additional grid suppression feature. Grid Suppression is not dependent on panel acquisition mode.
The Nexus DR™ Digital X-ray Imaging System (with Grid Suppression) 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 Grid Suppression) 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.
Anti-scatter grids are used in radiography to improve image quality by reducing the amount of scatter X-rays from reaching the imaging receptor which, in turn, increases image contrast. The Nexus DR™ Digital X-ray Imaging System (with Grid Suppression) uses an intuitive software algorithm to detect and suppress the line artifacts caused by anti-scatter grids. Only minor modifications were necessary to implement Grid Suppression software for this device. All other features and functions remain unchanged.
| Feature/Item | Nexus DR™<br>Digital X-ray Imaging<br>System (PaxScan<br>4336Wv4) | Nexus DR™<br>Digital X-ray Imaging<br>System (Grid<br>Suppression) |
|------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Device Type | Predicate Device | Subject Device |
| 510 (k) Number | K161459 | TBD |
| Flat Panel<br>Detector | Varian<br>PaxScan 4336Wv4 | Same |
| Detector<br>Material | a-Si sensor array with<br>CsI or Gd2O2S:TB<br>scintillator | Same |
| Detector<br>Dimensions | 17" x 14" | Same |
| Pixel<br>Size | 139 x 139 microns | Same |
| Detector Element | 3072 x 2560 | Same |
| Matrix | | |
| Dynamic<br>Range | 16 bits | Same |
| Uniform<br>Density | 1.52 | Same |
| Spatial<br>Resolution | 3.2 lp/mm | Same |
| Sensitivity | 540 @ 1.1uGy/frame<br>1206 @ 3.9uGy/frame<br>4290 @ 10uGy/frame<br>12804 @ 30uGy/frame<br>(16-bit subject panel) | Same |
| Signal to Noise<br>Ratio | 73 @ 2.8uGy/frame<br>117 @ 7uGy/frame<br>174 @ 17uGy/frame<br>285 @ 50uGy/frame | Same |
| Modulation<br>Transfer<br>Function | 0.551 @ 1cycle/mm<br>0.234 @ 2cycles/mm<br>0.099 @ 3cycles/mm | Same |
| Detective<br>Quantum<br>Efficiency | 0.232 @ 1cycle/mm<br>0.15 @ 2cycles/mm<br>0.07 @ 3cycles/mm | Same |
| 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 |
| Total Image<br>Processing Time | 10 seconds<br>per image | Same |
| Power<br>Requirements | 110/120V,<br>230/240V,<br>50/60 Hz | Same |
| Grid<br>Suppression | No | Yes |
| Panel Acquisition<br>Mode | vTrigger | vTrigger<br>or RAD Mode |
| Generator<br>Interface | Not Applicable | Applicable* |
## Comparison Chart:
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Image /page/6/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of three diagonal lines in blue, yellow, and green. To the right of the "V" is the word "VAREX" in blue, with the word "IMAGING" in smaller blue letters below it. The logo is clean and modern, and the colors are bright and eye-catching.
* Generators meeting these requirements can be interfaced with the Nexus DR™ Digital X-ray Imaging System (with Grid Suppression) 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.
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Image /page/7/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of three diagonal lines in different shades of green and blue. To the right of the "V" is the word "VAREX" in a dark blue sans-serif font. Below "VAREX" is the word "IMAGING" in a smaller, lighter blue sans-serif font.
For example, the following generators are capable of interfacing with the Nexus DR™ Digital X-ray Imaging System (with Grid Suppression) in RAD Mode.
| Manufacturer | Model |
|------------------|----------------|
| Bennett | HFQ-1250P |
| Bennett | HFQ-1000 |
| CGR | Prestilix 1600 |
| CPI | CMP200 |
| CPI | Indico 100 |
| CPI | IQ |
| CPI | Millennia |
| 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:
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Image /page/8/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" 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, with the "X" in green. Below "VAREX" is the word "IMAGING" in smaller, light-blue letters.
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 Grid Suppression) is as safe and effective as the predicate devices and does not raise different questions of safety and effectiveness.
## Clinical Tests Discussion:
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.
Clinical images were not necessary to establish substantial equivalence based on the modifications to the device (the PaxScan 4336Wv4 Flat Panel Detector uses 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):
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Image /page/9/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" 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, with the "X" in green. Below the word "VAREX" is the word "IMAGING" in a smaller, sans-serif font, also in blue.
- 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
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 Grid Suppression) 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.
