Who is the manufacturer of SyncVision System?

Volcano Corporation filed the 510(k) submission for SyncVision System (K172574).

What is the FDA product code for SyncVision System?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SyncVision System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SyncVision System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SyncVision System

K172574 · Volcano Corporation · OWB · Oct 5, 2017 · Radiology

Device Facts

Record ID	K172574
Device Name	SyncVision System
Applicant	Volcano Corporation
Product Code	OWB · Radiology
Decision Date	Oct 5, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2

Intended Use

The SyncVision System is an image acquisition and processing system. It is indicated for use as follows: · To provide quantitative information regarding the calculated dimensions of arterial segments. · To enhance visualization of the stent deployment region. · To be used in-procedure in the catheterization lab and off-line for post-procedural analysis. · To obtain a co-registration of an angiographic x-ray image and IVUS images. · To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values.

Device Story

SyncVision System is an image acquisition and processing workstation used in catheterization labs. It captures fluoroscopic x-ray streams, IVUS images, and FFR/iFR pressure wire data. The system automates co-registration of these modalities, allowing clinicians to view aligned anatomical locations on a single display. It performs quantitative coronary analysis (QCA) including lesion diameter, length, and stenosis percentage. It provides temporal and spatial filtering for stent deployment visualization. The system replaces manual registration workflows, reducing the need for clinicians to visually estimate identical locations across separate monitors. It supports in-procedure guidance and post-procedural analysis. Benefits include improved visualization, streamlined workflow, and precise anatomical correlation for interventional cardiologists.

Clinical Evidence

No clinical data was required. Substantial equivalence was demonstrated through non-clinical performance testing, including software verification (unit, integration, system level), QCA verification, IVUS/FM co-registration verification, and usability/human factors engineering validation. All tests met predefined acceptance criteria.

Technological Characteristics

Workstation-based image processing system. Hardware includes medical-grade isolation transformer (600VA), USB joystick, keyboard, mouse, and monitor. Connectivity via site-specific cables to existing fluoroscopy/IVUS systems. Software-based QCA using digital edge detection via density curve gradients and least-cost optimization. Operates on Windows 7 64-bit. Class I equipment per IEC/EN 60601-1.

Indications for Use

Indicated for use in catheterization labs by clinicians, technicians, and research personnel for trans-catheter cardiovascular diagnostic and therapeutic interventions on the heart and connected blood vessels. Used for quantitative arterial measurements, stent visualization, and co-registration of angiographic x-ray images with IVUS or intravascular blood pressure data.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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

SyncVision System (K161756)

Related Devices

K161756 — SyncVision System · Volcano Corporation · Sep 5, 2016
K132558 — SYNC-RX SYSTEM · Volcano Corporation · Dec 12, 2013
K151904 — SyncVision System · Volcano Corporation · Jul 31, 2015
K100849 — SYNC-RX SYSTEM, MODEL AS00010 · Sync-Rx, Ltd. · May 21, 2010
K253714 — IntraSight Plus · Philips Image Guided Therapy Corporation · Feb 24, 2026

Submission Summary (Full Text)

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 5, 2017 Volcano Corporation % Ms. Elaine Alan Regulatory Affairs Specialist 3721 Valley Centre Drive. Suite 500 SAN DIEGO CA 92130 Re: K172574 Trade/Device Name: SyncVision System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB Dated: August 25, 2017 Received: August 28, 2017 Dear Ms. Alan: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. {1}------------------------------------------------ the quality systems (OS) 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 (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. 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172574 Device Name SyncVision System #### Indications for Use (Describe) - The Sync Vision System is an image acquisition and processing system. It is indicated for use as follows: - · To provide quantitative information regarding the calculated dimensions of arterial segments. - · To enhance visualization of the stent deployment region. - · To be used in-procedure in the catheterization lab and off-line for post-procedural analysis. - · To obtain a co-registration of an angiographic x-ray image and IVUS images. - · To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the word "VOLCANO" in large, bold, blue letters. To the left of the word is a gray square with rounded corners. Inside the square is a white triangle with a blue triangle inside of it. The blue triangle is pointing downwards. # 510(k) Summary This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. | Date Prepared: | September 29, 2017 | |----------------|--------------------| |----------------|--------------------| # CONTACT/ | SUBMITTER: | Elaine Alan Regulatory Affairs Specialist Volcano Corporation 3721 Valley Center Dr. San Diego, CA 92130 | | Tel: 858-764-1281 Email: ealan@volcanocorp.com | |---------------|----------------------------------------------------------------------------------------------------------------------|-----------|---------------------------------------------------| | Manufacturer: | Volcano Corporation 2870 Kilgore Road Rancho Cordova, CA 95670 Establishment Registration Number: 2939520 | | | | DEVICE: | Trade Name: | | SyncVision System | | | Common Name: | | SyncVision System | | | Classification Name: | | Interventional fluoroscopic x-ray system | | | Classification: | | 21 CFR 892.1650 | | | Device Class : | Class II | | | | Product Code: | OWB | | | | Panel: | Radiology | | PREDICATE DEVICE: SyncVision System, K161756 Volcano Corporation Philips Volcano, 3721 Valley Centre Drive, Suite 500, San Diego, CA 92130 USA www.volcanocorp.com, Tel 800 228 4728, Fax 916 638 8112 {4}------------------------------------------------ ## DEVICE DESCRIPTION: The current standard procedure in the catheterization laboratory (cath lab) for utilizing x-ray and IVUS image streams calls for referencing the native x-ray, IVUS and FFR/iFR imaging and displayed value streams of the patient's vasculature separately on different displays or monitor. This configuration requires the physician, usually an interventional cardiologist, to estimate an identical location on the patient's vasculature location on both the x-ray, IVUS image streams, and FFR/iFR displayed value streams visually on adjacent windows on the same display. The SyncVision System (System) is displayed on a monitor that is situated next to the native xray, IVUS and FFR/iFR imaging and displayed value streams either in the cath lab or in the control room. The System provides a means to view the angiographic, IVUS, and FFR/IFR values on a single display and automates the manual registration processes performed by the physician. The objective of the SyncVision System is to optimize and facilitate trans-catheter cardiovascular interventions by means of automated on-line image processing. The current focus of the SyncVision System is on trans-catheter diagnostic and therapeutic interventions performed on the heart and the blood vessels directly connected to it. The SyncVision System's core component is an image acquisition and processing workstation situated in the coronary catheterization control room. The System also includes additional components such as a procedure room joystick, control room monitor, keyboard and mouse, medical grade isolation transformer along with site-specific cables and video equipment. Cables also connect the workstation to an existing output monitor (not supplied with the System) situated in the procedure room and provide the user in the procedure room with the visual output of the System side-by-side to the existing displays. The SyncVision System intends to capture the fluoroscopic image stream on line and perform the following functions for the purpose of assisting the interventional cardiologist in visualizing and quantitating the information resulting from images produced by the existing imaging modalities: - During lesion evaluation: Angiogram selection, quantitative coronary measurements (lesion diameters, length, and stenosis percentage), vessel region enhancement and vessel region stabilization are performed instantly and on line. - During device positioning, deployment and post-deployment: An on-line image stream, that is enhanced and stabilized, is displayed side-by-side with the existing fluoroscopic image stream. - . Import and display of IVUS images, leading to a joint display of images acquired by X-Ray and IVUS images corresponding to same selected luminal locations or segments (also known as IVUS Co-registration). - Import and display of Physiological values, leading to a joint display of images acquired by X-Ray and Physiological values corresponding to same selected luminal locations or segments (also known as Physiological Co-registration). The Co-Registration is an automation of a manual workflow process used by interventional cardiologists today. The manual procedure in the cath lab for utilizing x-ray and IVUS image {5}------------------------------------------------ streams calls for referencing the native x-ray and IVUS image streams of the patient's vasculature separately on different displays. This configuration requires the cardiologist to estimate an identical location on the patient's vasculature on the two native image streams (xray and IVUS) on two separate displays. The SyncVision System automates this process by providing an option to display an identical anatomical location on both the x-ray and IVUS image streams automatically on adjacent windows on the same display. # INDICATIONS FOR USE: The SyncVision System is an image acquisition and processing system. It is indicated for use as follows: - To provide quantitative information regarding the calculated dimensions of arterial segments. - To enhance visualization of the stent deployment region. - To be used in-procedure in the catheterization lab and off-line for post-procedural analysis. - To obtain a co-registration of an angiographic x-ray image and IVUS images. - To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values. The primary modifications are to software of the SyncVision Software to enhance the Physiology Co-Registration capability, which correlates between physiological values obtained from Volcano's pressure wire pullback (both iFR and FFR calculations) and their respective locations on a selected angiographic image. There are also administrative, infrastructure, and service modifications. The primary modifications of the new device compared to the predicate device are provided in the Modification Comparison table below. | Proposed Modification | Predicate Device SyncVision System SW 4.0/HW 2.1 K161756 | Proposed Device SyncVision System SW4.1/HW2.1 | Comments | |------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Automated Roadmap: Automation of the Pathway indication phase in the Physiology Co- Registration workflow | During co-registration set-up, after performing an angiogram and the pressure wire pullback, the system selects the angiogram frame to be used then the user manually indicates the pathway to be used for the physiology pullback. | During co-registration set-up, after performing an angiogram and the pressure wire pullback, the system selects the angiogram frame and automatically calculates the pathway to be used for co- registration. | Eliminates the need to perform the manual processes. The user may still elect to edit or manually draw the pathway. A new Edit Pathway button has been added to the GUI for this function. | | Co-registration region indication represented by white triangle at the proximal & distal ends of the co-registration region. | During co-registration set-up, after performing an angiogram and the pressure wire pullback, the area in which the pullback was performed is not indicated. | During co-registration set-up, after performing an angiogram and the pressure wire pullback, the area in which the pullback was performed is marked | Aids the user in visualizing the area of interest of the vessel that was used for Co- Registration. | | Proposed Modification | Predicate Device SyncVision System SW 4.0/HW 2.1 K161756 | Proposed Device SyncVision System SW4.1/HW2.1 | Comments | | Display of Measurement Points - Display white dots on the roadmap, representing the iFR measurement location. | Display of 'white dots' not available. In the current system to view a single measured point the user clicks along the Roadmap and the cursor indicates the measured location on the Roadmap. | The measured points will appear as 'white dots' along the Roadmap. The user is able to view and click all measured points along the Roadmap. | Provides the user with a visual aid of where the values were measured during pullback. | | Allow multiple length measurements in the Physiology Co-Registration results tab | The user can perform only one length measurement at a time along the vessel or the trend line. | The user can perform multiple length measurements at a time along the vessel or the trend line. | New feature enhancement. | | Enhancement related to Tri-registration workflow | After performing Tri- registration between Angiography, Physiology, and IVUS the user must switch between screens to see the desired view. | After performing Tri- registration a joint display comprising of Angiography, Physiology, and IVUS Co-Registration data is provided on one screen. | Improvement to workflow | | Enhancement related to Tri-registration workflow | The user needs to perform an IVUS Co- Registration first and then perform Physiology Co-Registration using the same Roadmap image in order to obtain Tri- Registration. | The workflow is flexible as the user can perform Co- Registrations in any order. | Improvement to workflow | | Addition of "iFR Estimated" calculation on the GUI | When performing a single length measurement the system calculates and displays the number of yellow pressure drops within a length measurement, this is called "iFR drop in selection" (which is not a new feature). The physician then manually adds this number to the iFR distal value shown on the screen as a supplement reference. | When performing single or multiple length measurements the system calculates the number of the yellow pressure drops within the length measurement, this is called "iFR drop in selection". The System adds this number to the iFR distal value and displays the result on the screen as "iFR Estimated". | The result of the calculation is shown on the screen as an iFR Estimated value. This value will now be displayed for ease of use to the clinician. | | Proposed Modification | Predicate Device SyncVision System SW 4.0/HW 2.1 K161756 | Proposed Device SyncVision System SW4.1/HW2.1 | Comments | | Compatibility with new Volcano FFR Software (SW) version 2.5 | Compatible with FFR Software version 2.4.1 | Compatible with FFR Software version 2.5 | Compatible with the latest software version | | Compatibility with the new pressure wire Verrata® Plus | Compatible with Verrata pressure wire | Compatible with Verrata Plus pressure wire | Additional pressure wire compatibility added | | Removal of the use of the ECG signal | The system can process Co-registration with or without an ECG signal: -if ECG is used the System uses the ECG signal for automatic angiogram frame selection -if ECG is not used System selects the middle frame of the angiogram. | Removed the ECG signal option. The System automatically selects the angiogram frame. | Removed ECG option from workflow. The option to modify the frame selection or manually select an angiogram frame is still available to the user. | ## Modification Comparison {6}------------------------------------------------ {7}------------------------------------------------ # SUMMARY OF TECHNOLOGICAL CHARACTERISTICS: The subject device provides additional angiographic features to the predicate device SyncVision System, cleared under K161756. There are no hardware or component changes. The software changes are enhancements to the current features, administrative, infrastructure, and service changes. This submission is for software and subsequent labeling changes. The devices are identical in terms of: - Indications for use, - Design, - Materials, - . Specifications, - Principles of Operation, and ● - Fundamental Scientific Technology. ● A comparison of the technological characteristics between the new device and those of the predicate device is provided in the Technological Comparison table below: | Technical Attributes | Predicate Device SyncVision System SW 4.0/HW 2.1 K161756 | Proposed Device SyncVision System SW4.1/HW2.1 | Comment | |--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The SyncVision System is an image acquisition and processing system. It is indicated for use as follows: • To provide quantitative information regarding the | The SyncVision System is an image acquisition and processing system. It is indicated for use as follows: • To provide quantitative information regarding the | Same | | Technical Attributes | Predicate Device SyncVision System SW 4.0/HW 2.1 K161756 | Proposed Device SyncVision System SW4.1/HW2.1 | Comment | | | calculated dimensions of arterial segments. - To enhance visualization of the stent deployment region. - To be used in-procedure in the catheterization lab and off-line for post-procedural analysis. - To obtain a co-registration of an angiographic x-ray image and IVUS images. - To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values. | calculated dimensions of arterial segments. - To enhance visualization of the stent deployment region. - To be used in-procedure in the catheterization lab and off-line for post-procedural analysis. - To obtain a co-registration of an angiographic x-ray image and IVUS images. - To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values. | | | User Group | Intended for use by clinicians, technicians and research personnel | Intended for use by clinicians, technicians and research personnel | Same | | Application | Accessory to existing vessel image systems for image manipulation and co-registration and to provide vessel measurements | Accessory to existing vessel image systems for image manipulation and co-registration and to provide vessel measurements | Same | | Use Environment | To be used in the catheterization lab; online during the procedure, and offline for immediate post- procedural analysis. | To be used in the catheterization lab; online during the procedure, and offline for immediate post- procedural analysis | Same | | Compatibility with the catheter- laboratory fluoroscopy Systems | - Siemens Axiom Artis & Siemens Artis Zee - Philips Allura Xper FD10/20 & Philips Allura Clarity - GE Innova - Toshiba Infinix - Shimadzu Trinias/Voyager | - Siemens Axiom Artis & Siemens Artis Zee - Philips Allura Xper FD10/20 & Philips Allura Clarity - GE Innova - Toshiba Infinix - Shimadzu Trinias/Voyager - Philips Intuis - Philips Azurion (Allura R9) | Additional systems | | Compatible with the following IVUS system & catheters | - Volcano s5/CORE Systems with SW version 3.2.2 and above, and FM software version 2.4.1 - Eagle Eye Platinum IVUS catheter - Verrata pressure guide wire | - Volcano s5/CORE Systems with SW version 3.4 and 3.5, and FM software version 2.5 - Eagle Eye Platinum IVUS catheter - Verrata pressure guide wire - Verrata Plus pressure guide wire | Updated to current s5/CORE Systems software, and the FM software version 2.5. Additional pressure guide wire | | | Predicate Device SyncVision System SW 4.0/HW 2.1 K161756 | Proposed Device SyncVision System SW4.1/HW2.1 | Comment | | Technical Attributes | | | | | Compatible ECG Monitors | Compatible with most modern ECG monitors which are equipped with an Auxiliary output signal and are commonly used in the cath-lab and have analog outputs (input range $\pm$ 10V). ADC resolution: 16 bit. Minimum amplitude required is 200mV. The configuration of the SyncVision System is compatible with common layouts and configurations of catheter laboratories. | N/A | ECG acquisition is no longer required for angiogram frame selection | | Image Source | Angiography/fluoroscopy/ Intravascular Ultrasound (IVUS)/ FFR/iFR pressure wires | Angiography/fluoroscopy/ Intravascular Ultrasound (IVUS)/ FFR/iFR pressure wires | Same | | Source Image Type | Native angiography/fluoroscopy/ultrasound images | Native angiography/fluoroscopy/ultrasound images | Same | | Image Size | Any image size, according to native source image | Any image size, according to native source image | Same | | Image Depth support | X-Ray: 8 bit grayscale IVUS: 24 bit RGB or converted to an 8 bit grayscale to display IVUS in black & white | X-Ray: 8 bit grayscale IVUS: 24 bit RGB or converted to an 8 bit grayscale to display IVUS in black & white | Same | | Image Frame Selection for Measurements | Angiogram - The system automatically presents an image frame, and in most cases this will be a frame in which the vessel is filled with contrast media IVUS - User selectable FFR/iFR - user selectable | Angiogram - The system automatically presents an image frame, and in most cases this will be a frame in which the vessel is filled with contrast media IVUS - User selectable FFR/iFR - user selectable | Same | | Manual Override | Manual override of selected angiogram or IVUS image | Manual override of selected angiogram or IVUS image | Same | | Quantitative Information | Quantitative Coronary Analysis (QCA) applied to angiogram and IVUS images | Quantitative Coronary Analysis (QCA) applied to angiogram and IVUS images | Same | | QCA Interface | The user marks the designated lesion, location, or diameter using a point-and-click input device | The user marks the designated lesion, location, or diameter using a point-and-click input device | Same | | QCA Calibration | Optional, using the Guiding Catheter. If a calibration was not performed, only the % stenosis will be calculated and displayed | Optional, using the Guiding Catheter. If a calibration was not performed, only the % stenosis will be calculated and displayed | Same | | Edge Detection | Digital edge detection by calculation of the derivatives (or gradients) of the density curve across the lumen and finding their | Digital edge detection by calculation of the derivatives (or gradients) of the density curve across the lumen and finding their | Same | | | Predicate Device SyncVision System | Proposed Device | | | Technical Attributes | SW 4.0/HW 2.1 | SyncVision System SW4.1/HW2.1 | Comment | | | K161756 | | | | | peak values, followed by least-cost | peak values, followed by least-cost | | | QCA Display | optimization Angiogram: Vessel walls superimposed on the vessel image in addition to Minimum Lumen Diameter (MLD) marker line and two reference-point marker lines. IVUS: Diameter is displayed on the IVUS axial image and length is displayed on the IVUS longitudinal view | optimization Angiogram: Vessel walls superimposed on the vessel image in addition to Minimum Lumen Diameter (MLD) marker line and two reference-point marker lines. IVUS: Diameter is displayed on the IVUS axial image and length is displayed on the IVUS longitudinal view | Same | | Vessel | MLD (mm), segment diameter(s) (mm), segment length (mm), reference diameter (mm) and % stenosis | MLD (mm), segment diameter(s) (mm), segment length (mm), reference diameter (mm) and % stenosis | Same | | QCA Measurement Precision | -MLD Precision: 0.15 mm - % Narrowing Precision: 5% - Segment Precision: 0.5 mm | -MLD Precision: 0.15 mm - % Narrowing Precision: 5% - Segment Precision: 0.5 mm | Same | | IVUS C- Registration Measurements: (Diameter and Length | Diameter: Precision ≤ 0.1mm Length: Precision ≤ 0.5mm | Diameter: Precision ≤ 0.1mm Precision ≤ 0.5mm | Same | | Manual Diameter Measurements on axial IVUS images | Precision ≤ 0.1mm | Precision ≤ 0.1mm | Same | | Area Measurement Precision | Precision ≤ ±0.1mm² | Precision ≤ ±0.1mm² | Same | | FFR/iFR Co- Registration Length Measurements | Precision ≤ 2.0 mm | Precision ≤ 2.0 mm | Same | | Balloon/Stent Enhancement | Enhanced visualization of the stent deployment region by tracking and alignment of balloon markers, and averaging of multiple consecutive frames. Enhancement is performed by means of temporal and spatial filtering of the aligned frames. | Enhanced visualization of the stent deployment region by tracking and alignment of balloon markers, and averaging of multiple consecutive frames. Enhancement is performed by means of temporal and spatial filtering of the aligned frames. | Same | | Method Enhancement Algorithm | Marker detection and alignment Enhancement is performed by means of temporal and spatial filtering of the aligned frames | Marker detection and alignment Enhancement is performed by means of temporal and spatial filtering of the aligned frames | Same | | Technical | Predicate Device SyncVision System | Proposed Device SyncVision System | Comment | | Attributes | SW 4.0/HW 2.1 K161756 | SW4.1/HW2.1 | | | Power Supply | Medical grade isolation transformer 600VA - Toroid ISB- 060W or compatible | Medical grade isolation transformer 600VA - Toroid ISB- 060W or compatible | Same | | Joystick | Standard USB, 2-button | Standard USB, 2-button | Same | | Joystick Catheterization | EUR RAIL 10 x 25 mm US RAIL 3/8" x 1 | EUR RAIL 10 x 25 mm US RAIL 3/8" x 1 | Same | | Table Rail Compatibility | 1/8"(9.52x28.57mm) | 1/8"(9.52x28.57mm) | | | Monitor | Flat panel 19" or above monitor with VGA and DVI inputs Resolution 1280x1024 or above | Flat panel 19" or above monitor with VGA and DVI inputs Resolution 1280x1024 or above | Same | | Mouse and Keyboard | Keyboard: standard USB keyboard Mouse: Standard USB mouse | Keyboard: standard USB keyboard Mouse: Standard USB mouse | Same | | Operating System | Windows 7 64bit Professional Ed. | Windows 7 64bit Professional Ed | Same | | Electrical Specifications | Class I equipment, per IEC/EN 60601-1 H/W v2.0: Input 120V to 240V auto voltage selector 50/60Hz Output 120V-240V voltage selector 50/60Hz | Class I equipment, per IEC/EN 60601-1 H/W v2.1: Input 100V to 240V auto voltage selector 50/60Hz Output 100V-240V voltage selector 50/60Hz Minimum power 400VA (at 240V) Minimum outputs 4 (IEC320 C14 socket) Over load protection fuse 100V & 240V On/Off switch Power cord: medical grade minimum wire diameter AWG18 (0.75mm²) 3.5m max length Fuses: 100VA 8.0A, 120VAC: 6.3A, 240VAC: 3.15A | H/W v2.0 not compatible with SyncVision SW version 4.1 | | Environmental Conditions | Ambient temperature range: +15°C to +35°C (+59°F to +95°F) Relative humidity range: 30% - 85% Atmospheric pressure range 700hpa to 1060hpa…

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