Visaris Vision® (Vision C, Vision U. Vision V, Vision X)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 30, 2016 VISARIS d.o.o. Belgrade % Mr. Daniel Kamm Prinicipal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114 Re: K160620 Trade/Device Name: Visaris Vision® (Vision C, Vision U, Vision V, Vision X) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: February 29, 2016 Received: March 4, 2016 Dear Mr. Kamm: 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 (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. {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 at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 yours. Michael D'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) K160620 Device Name Visaris Vision® (Vision C, Vision U. Vision V, Vision X) Indications for Use (Describe) The purpose of Visaris Vision® is to acquire, store, communicate, display and process medical X-ray images. These radiographic systems are intended for use by a qualified/trained physician or both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-variant: normal;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="word-spacing: normal;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="orphans: 2;"> <span style="widows: 2;"> <span style="display: inline !important;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-variant: normal;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="word-spacing: normal;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="orphans: 2;"> <span style="widows: 2;"> <span style="display: inline !important;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Belgrade ### Visaris Vision® (Vision C, Vision U. Vision V, Vision X) K160620 ### 1. Administrative Information ### Reason for Submission: 510(k) Notification for Visaris Vision®, a new device ### Submitter: | VISARIS d.o.o. Belgrade | | |----------------------------|----------------------------------------------------------| | Address: | Batajnički drum 10 deo 1b | | | 11080 Zemun | | | SERBIA | | Submission contact person: | Mr. Milan Ratković | | Contact telephone: | +381 11 2017 631 | | Contact e-mail: | mratkovic@visaris.com | | Date prepared: | January 19, 2016 | | Trade Names: | Visaris Vision® (Vision C, Vision U. Vision V, Vision X) | | Classification Name: | Stationary X-Ray System | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | | Device Class: | Class II | | Product Code: | KPR | #### Substantially equivalent device: | Trade Name: | Multix Fusion | |----------------------------|-------------------------| | Manufacturer: | Siemens | | 510(k) #: | K121513 | | Clearance Date: | August 10, 2012 | | Classification Name: | Stationary X-Ray System | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | | Device Class: | Class II | | Product Code: | KPR | ## 2. Device description: 21 CFR 807 92 (a) (4) Visaris Vision combines our Visaris Avanse® cleared PACS software (K150725) with all the other components required to make a complete digital diagnostic X-ray system, including tube stands, tube heads, collimators, generators, tables, and (already cleared) digital X-ray panels. Visaris Avanse®, the software component, is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detector technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control, image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module), DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows {4}------------------------------------------------ XP/7/8 operating system on any hardware platform meeting the minimum system requirements. These models are available: Vision C: A universal digital system employing an Overhead Tube Crane, a table, and a wall stand. Vision U: A universal U-Arm system Vision V: A floor mounted tube system Vision X: A universal straight Arm system All of these come with the previously cleared Visaris 360, the integrated digital radiology workflow system. (Visaris Avance, K150725) Various Brands of generators and Models available: (All HF) (All meet the US Performance Standard): Claymount, (up to 63 kW) CPI, (32kW to 100kW) EMD, (45 kW, to 80 kW) POSKOM (32 kW to 50 kW) Sedecal (40, 50, 65, or 80 kW) Visaris only supplies digital x-ray panels that have previously been cleared by FDA. This device employs our previously cleared software K150725. All of the panels listed below were previously tested with our software: | Detector | Clearance(s) | |--------------------------|----------------------------------------------------------------------| | Careray 1500-1800 Series | K153492 K153058 K141488 K150929 | | DRTech (Multiple Models) | K132842 K111655 K111583 K111344 K102474 K102284 K091747<br>K080064 | | iRay Venu | K123644 | | Konica AeroDr | K151465 K141271 K130936 | | Perkin Elmer XRPAD | K140551 | | Rayence XMARU | K140646, K131114, K130935 K123345 K122928 K122919 K122173<br>K122182 | | Toshiba FDX | K130883 | | Trixell Pixium | K131483 | | Varian PaxScan | K130318, K024147 | | Vieworks Vivix | K120020, K122866, K122865 | ## 3. Indications for Use: 21 CFR 807 92 (a) (5) The purpose of Visaris Vision® is to acquire, store, communicate, display and process medical X-ray images. These radiographic systems are intended for use by a qualified/trained physician or both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use. {5}------------------------------------------------ # 4. Technological characteristics: 21 CFR 807 92 (a) (6) Comparison Table | Comparable<br>Properties | Predicate Device: Siemens Multix<br>Fusion K12113 | Vision C, Vision U, Vision V, Vision X Digital Radiography Systems | Comparison Results | |-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Indications for<br>use | The Multix Fusion is a radiographic<br>system used in hospitals, clinics, and<br>medical practices. Multix Fusion enables<br>radiographic exposures of the whole<br>body including: skull, chest, abdomen,<br>and extremities and may be used on<br>pediatric, adult, and bariatric patients. It<br>can also be used for intravenous, small<br>interventions (like biopsy, punctures,<br>etc.) and emergency (trauma, critically ill)<br>applications. Exposures may be taken<br>with the patient sitting, standing, or in<br>the prone position. The Multix Fusion<br>system is not meant for mammography.<br>The Multix Fusion uses a mobile (wired)<br>or portable (wireless) digital detector for<br>generating diagnostic images<br>by<br>converting x-rays into electronic signals.<br>The Multix Fusion is also designed to be<br>used with conventional film/screen or<br>Computed Radiography (CR) cassettes. | The purpose of Visaris Vision® is to<br>acquire, store, communicate, display<br>and process medical X-ray images.<br>These radiographic systems are<br>intended for use by a qualified/trained<br>physician or technician on both adult<br>and pediatric subjects for taking<br>diagnostic x-rays. Not for<br>mammography, angiography,<br>interventional, or fluoroscopy use. | Equivalent | | Tube<br>crane/Tube<br>stand | Overhead tube crane with manual or<br>automated x-ray tube<br>assembly<br>movement. | Equivalent model: Vision C | Equivalent<br>Functionality | | Wall stand | Manual vertical movable wall stand,<br>tiltable tray. | Motorized | Equivalent<br>Functionality | | Table | Free-floating and height-adjustable,<br>maximum patient weight 660 lbs.,<br>working table height 20-5/16 inch to<br>37-5/8 inch. | Same. | Equivalent<br>Functionality | | X-ray tube | 150 kVp, 0.6 mm & 1 mm focal spots. | 150 kVp 0.6/1.2mm focal spots | Equivalent<br>Functionality | | Collimator | Siemens. | Claymount, X-Alliance, or Ralco (All<br>CFR Certified) | Equivalent<br>Functionality | | X-ray<br>Generator | 55, 65, or 80 kW Siemens brand | Various Models available: (All HF)<br>Claymount, (up to 63 kW)<br>CPI, (32kW to 100kW)<br>EMD, (45 kW, to 80 kW)<br>POSKOM (32 kW to 50 kW)<br>Sedecal (40, 50, 65, or 80 kW)<br>(All CFR Certified) | Equivalent<br>Functionality | | Comparable<br>Properties | Predicate Device: Siemens Multix<br>Fusion K12113 | Vision C, Vision U, Vision V, Vision X<br>Digital Radiography Systems | Comparison<br>Results | | Wireless<br>detector | 14" x 17" | 14" x 17" Uses FDA cleared<br>detector and software. Pixium<br>3543 EZ C (Other previously cleared<br>models available, see table above) | Equivalent<br>Functionality | | Fixed<br>detector | 17" x 17" | 17"x17". Uses FDA cleared<br>detector and software. Pixium<br>4343RC (Other previously cleared<br>models available) | Equivalent<br>Functionality | | Conventional<br>film/screen<br>systems or<br>CR cassettes | Film/Screen or CR Cassettes. | Comes with FDA cleared digital x-<br>ray panels. Conventional film and<br>CR cassettes can still be used. | Similar<br>Functionality | | Operator<br>console | GUI-based | Same | Similar<br>Functionality | | Photos | Image: Siemens Multix Fusion K12113 | Image: Vision C, Vision U, Vision V, Vision X Digital Radiography Systems | Similarity is<br>obvious. | | Power<br>Source | AC LINE | SAME | Same. | | Standards | 60601-1:2005; 60601-1-2:2014<br>60601-2-54 Edition 1.0; PS 3.1 - 3.20<br>(2011) 21CFR1020 | SAME | SAME | {6}------------------------------------------------ # 5. Non clinical testing Testing was performed successfully according to the following standards: | FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Standard Designation<br>Number And Date | Title Of Standard | |------------------------------|----------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 19-5 | IEC | 60601-1:2005 | Medical Electrical Equipment Part 1: General<br>Requirements For Basic Safety And Essential<br>Performance (IEC 60601 1:2005, MOD) | | 19-1 | IEC | 60601-1-2:2014 | Medical Electrical Equipment Part 12: General<br>Requirements For Basic Safety And Essential Performance<br>Collateral Standard: Electromagnetic Disturbances<br>Requirements And Tests | {7}------------------------------------------------ | FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Standard Designation<br>Number And Date | Title Of Standard | |------------------------------|----------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 12-274 | IEC | 60601-2-54 Edition<br>1.0 | Medical Electrical Equipment Part 2-54: Particular<br>Requirements For The Basic Safety And Essential<br>Performance Of X- Ray Equipment For Radiography And<br>Radioscopy [Including: Technical Corrigendum 1 (2010),<br>Technical Corrigendum 2 (2011)] | | 12-238 | NEMA | PS 3.1 - 3.20 (2011) | NEMA Digital Imaging and Communications in Medicine<br>(DICOM) Set | | N/A | FDA | 21CFR1020 | Electronic Products; Performance Standard for Diagnostic<br>X-Ray Systems and Their Major Components | All of the components subject to the CDRH performance standard are certified to comply with the standard by their respective manufacturers. We do not supply any non-certified components. All X-ray components (generators, tubes, collimators, and applicable accessories) carry an NRTL certification label (UL, ETL, etc.). The software employed was used unmodified from our clearance obtained in K150725. A detailed risk analysis was performed on the entire system, evaluating successful integration of the various components. # 6. Clinical testing Although not required for a determination of substantial equivalence, a clinical evaluation was performed with these objectives: - . verification in the normal working conditions of VISION C digital radiography device performances with respect to those claimed by the producer (Visaris d.o.o.) in their functional specification - . determination of all adverse effects in normal use and an estimate if these pose a risk with respect to the intended performance of the device. - evaluation of all known hazard sources and estimation of their actual risk to patients, operators or environment of the device in normal working condition The results were satisfactory. Confirmatory images were acquired with each of the proposed digital panels to assure system compatibility. ## 7. Substantial Equivalence Discussion. The Visaris Vision performs the same functions using the same technological methods to produce diagnostic x-ray images. In all material aspects, the Siemens and the Visaris systems are substantially equivalent to each other. ## Substantial Equivalence Conclusion: After analyzing bench test results, risk analysis, and clinical evaluation, it is the conclusion of VISARIS d.o.o. Belgrade Inc that the VISARIS Vision Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.