(283 days)
No
The summary describes image fusion, tracking, and augmented reality projection, but does not mention any AI or ML algorithms being used for image analysis, decision support, or other functions. The focus is on spatial registration and visualization.
No
The device is described as an augmented reality-based medical display workstation intended for visualization and interaction, providing visual information and reference for analysis, planning, and display of images. It is not intended for therapy or treatment.
No
The text explicitly states: "The XR90 (XR90-SYS) system is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis."
No
The device description explicitly states the system is comprised of a commercial, off-the-shelf augmented reality head-mounted display, a streamer, and an electromagnetic (EM) field generator, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- XR90 Intended Use: The XR90 is a medical display workstation used for visualizing and interacting with medical images (Ultrasound, CT) and tracked interventional devices. It is intended for pre-operative planning and intra-operative guidance during procedures. It does not involve the analysis of specimens from the human body.
- Device Description: The description focuses on augmented reality technology, image fusion, and tracking of instruments and anatomy for visual guidance. It does not mention any components or processes related to the analysis of biological samples.
Therefore, the XR90 falls under the category of medical devices used for image visualization and guidance during procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The XR90 (XR90-SYS) is a medical display workstation intended for 3D image visualization and image interaction in conjunction with traditional imaging and monitors. The virtual images are generated from tracked Ultrasound, tracked interventional device, and 3D volumetric data acquired from CT sources and stereoscopically projected such that the proximity of the virtual interventional device is displayed relative to live ultrasound and 3D models from previously acquired CT. The device is intended to provide visual information and reference to be used by the health care professionals for analysis of surgical options during pre-operative planning, and the heads-up, intra-operative display of the images during ultrasound-guided needle-based procedures. Virtual images on the heads-up display should always be used in conjunction with traditional monitors.
The XR90 (XR90-SYS) system is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis.
The XR90 (XR90-SYS) system is intended to be used as a reference display for consultation and guidance to assist the clinician who is responsible for making all final patient management decisions.
During system use, the position and orientation tracking of the interventional instruments should always be available to the clinician on traditional imaging and monitors.
Product codes
LLZ
Device Description
The MediView™ XR90 (XR90-SYS) system is an augmented reality-based medical device to be used adjunctively to clinical ultrasound (US) systems, with the ability to stereoscopically project and fuse standard-of-care US with digital anatomical models based on pre-procedural computed tomography (CT) imaging in biopsies and percutaneous ablations to overcome the limitations of two-dimensional image fusion. The XR90 (XR90-SYS) system provides visual information and remote collaboration features.
XR90 (XR90-SYS) and cleared image fusion devices spatially register and project virtual representations of a) tracked interventional instruments and b) imaged patient anatomy in a common coordinate system. Accordingly, the use of XR90 (XR90-SYS) involves the co-registration of virtual objects (tracked device, US, and CT) for visual information and does not involve use of stereoscopic projection to physical (i.e., real-world) anatomy for navigation, consistent with predicate devices. XR90 (XR90-SYS) spatially registers and stereoscopically co-projects three types of virtual objects: (1) Holographic Light Ray (HLR), (2) CT-based virtual anatomy, and (3) live ultrasound b-sector (Flashlight) with the HUD ultrasound display/augmented reality user interface, while maintaining the same principle of operation compared to predicate devices. Accordingly, the paired registration of holographic entities are:
- (1) HLR and virtual US-sector (Flashlight),
- (2) CT-based virtual anatomy and virtual US-sector (Flashlight), and
- (3) HLR and CT-based virtual anatomy.
The system is comprised of a commercial, off-the-shelf augmented reality head-mounted display, wirelessly connected to a streamer which interfaces with a GE Vivid iq ultrasound system and an electromagnetic (EM) field generator. The US signal is transmitted from the streamer to the headmounted display, where a virtual display of the US image is stereoscopically projected into the user's field-of-view in conjunction with pre-acquired CT-based images and tracked instrumentation.
The XR90 (XR90-SYS) system is capable of teleprocedural collaboration through the head-mounted display using Microsoft Dynamics 365 Remote Assist, allowing for other healthcare professionals to securely connect remotely to the head-mounted display, viewing the US signal and communicating (both through voice and needle annotation on the screen) in real-time with the local proceduralist. The remote collaborator may interact with the proceduralist via mobile device, laptop, desktop, or head-mounted display but the collaborator participates as an observer and should not make care decisions. The combination of teleprocedure communication and Holographic Needle Guide features provide workflow and ergonomics to the user for pre-operative planning and intra-operative display of virtual images. XR90 (XR90-SYS) is intended to be used adjunctively to standard of care imaging and provides guidance to the user. Proceduralists must refer to standard of care (conventional monitors) and prioritize clinical experience and/or judgement when using the XR90 (XR90-SYS) system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, previously acquired CT.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professionals, Hospital operating rooms and procedure rooms.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
Non-clinical bench testing on the XR90 (XR90-SYS) system was performed to demonstrate the system meets the performance specifications per the device's intended use. The testing concluded that XR90 (XR90-SYS) does not raise any new questions of safety and effectiveness. This included the System Accuracy Verification, Cadaver Study which concluded that the registration and fusion of virtual images was within acceptable limits in a phantom and cadaver model. Additionally, the system performance was evaluated in an animal model.
System accuracy performance testing summary:
Phantom: Mean TRE (mm) 2.543 mm, 95% Upper Bound for TRE (mm) 2.726 mm, TRE Measured at Mean Needle Depth of (cm): 7.1 cm.
Cadaver: Mean TRE (mm) 2.293 mm, 95% Upper Bound for TRE (mm) 2.825 mm, TRE Measured at Mean Needle Depth of (cm): 8.5 cm.
Animal: Mean TRE (mm) 2.9 mm, 95% Upper Bound for TRE (mm) 3.4 mm, TRE Measured at Mean Needle Depth of (cm): 7.6 cm.
Angular errors in an animal model:
In-plane angular errors: Mean Angular Error (degrees) 7.08°, 95% Upper Bound (degrees) 8.77°.
Out-of-plane angular errors: Mean Angular Error (degrees) 4.79°, 95% Upper Bound (degrees) 6.50°.
Other non-clinical testing:
- Bench testing performance tests verified: Measurement of Positional Accuracy of the EM Tracking Subsystem in accordance with ASTM F2554-22; Accuracy of the system registration, including Target Registration Error and Image Fusion Registration Error, in a benchtop phantom study and in a cadaver model, as well as measurement validation of distances measured in the system against a ground truth; Latency and data communication on the benchtop; Registration/image target tracking on the benchtop.
- Electrical safety tested in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.
- Electromagnetic Compatibility (EMC) tested in accordance with IEC 60601-1-2:2014.
- System cleaning and disinfection validation performed according to AAMI TIR 30:2011/(R)2016, AAMI TIR 12:2010, and FDA guidance:" Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" (March 17, 2015).
- Sterilization validation according to ISO 11135:2014.
- Biocompatibility of all user contact materials tested according to ISO 10993-1:2018 and FDA guidance on the use of ISO 10993-1.
- Software verification and validation testing conducted as required by IEC 62304 and FDA guidance on general principles of software validation, January 11, 2002.
- Usability evaluation validated the system with intended users in simulated use conditions to ensure tasks, including critical tasks, were met and no new issues of safety or effectiveness were raised.
A GLP porcine study evaluated the safety, efficacy, and accuracy (including Target Registration Error and angular errors) of the system when used in adjunct to standard-of-care imaging during ultrasound-guided needle-based procedures in porcine models. Secondary endpoints included evaluating overall procedure time, complications, and overall clinical usability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
MediView XR, Inc. Adam Cargill Director, QARACA 10000 Cedar Ave Ste# Gcic 2-153 CLEVELAND, OHIO 44106
July 13, 2023
Re: K223125
Trade/Device Name: Xr90 (xr90-sys) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: June 9, 2023 Received: June 12, 2023
Dear Adam Cargill:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb, Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223125
Device Name XR90 (XR90-SYS)
Indications for Use (Describe)
The XR90 (XR90-SYS) is a medical display workstation intended for 3D image visualization and image interaction in conjunction with traditional imaging and monitors. The virtual images are generated from tracked Ultrasound, tracked interventional device, and 3D volumetric data acquired from CT sources and stereoscopically projected such that the proximity of the virtual interventional device is dive to live ultrasound and 3D models from previously acquired CT. The device is intended to provide visual information and reference to be used by the health care professionals for analysis of surgical options during pre-operative planning, and the heads-up, intra-operative display of the images during ultrasound-guided needle-based procedures. Virtual images on the heads-up displays be used in conjunction with traditional monitors.
The XR90 (XR90-SYS) system is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis.
The XR90 (XR90-SYS) system is intended to be used as a reference display for consultation and guidance to assist the clinician who is responsible for making all final patient management decisions.
During system use, the position and orientation tracking of the interventional instruments should always be available to the clinician on traditional imaging and monitors.
Type of Use (Select one or both, as applicable)
| ☑ 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/0 description: The image contains the logo for MediView. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of curved lines in shades of blue, green, and orange. To the right of the graphic is the company name "MediView" in a blue sans-serif font, with the tagline "TRANSFORMATIVE VISION" in smaller, lighter blue letters below it.
510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR $807.92.
| Sponsor: | MediView XR, Inc.
10000 Cedar Ave
STE GCIC 2-153
Cleveland, OH 44106
Establishment Registration Number: 9102640
Phone: (661) 917-9775 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Adam Cargill
Director, QARACA |
| Date Prepared: | July 12, 2023 |
| Subject Device: | Trade Name: XR90 (XR90-SYS)
Submission Number: K223125
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management and Processing System
Regulatory Class: Class II
Product Code: LLZ
Common Name: System, Image Processing, Radiological |
| Predicate Device: | Trade Name: HOLOSCOPE-i
Premarket Notification: K210072
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management and Processing System
Regulatory Class: Class II
Product Code: LLZ
Common Name: System, Image Processing, Radiological |
| Reference Device: | Trade Name: PercuNav Image Fusion and Interventional Navigation
Premarket Notification: K170716
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed Tomography X-Ray System
Regulatory Class: Class II
Product Code: JAK
Common Name: System, X-Ray, Tomography, Computed
Associated Product Code: IYO, LLZ
Common Name: System, Imaging, Pulsed Echo, Ultrasonic |
Device Description
The MediView™ XR90 (XR90-SYS) system is an augmented reality-based medical device to be used adjunctively to clinical ultrasound (US) systems, with the ability to stereoscopically project and fuse standard-of-care US with digital anatomical models based on pre-procedural computed tomography (CT) imaging in biopsies and percutaneous ablations to overcome the limitations of two-dimensional image fusion. The XR90 (XR90-SYS) system provides visual information and remote collaboration features.
4
Image /page/4/Picture/0 description: The image contains the logo for MediView. On the left side of the logo is a circular graphic with three curved lines in the colors orange, blue, and green. To the right of the graphic is the company name "MediView" in blue, with the words "TRANSFORMATIVE VISION" in smaller green font underneath.
XR90 (XR90-SYS) and cleared image fusion devices spatially register and project virtual representations of a) tracked interventional instruments and b) imaged patient anatomy in a common coordinate system. Accordingly, the use of XR90 (XR90-SYS) involves the co-registration of virtual objects (tracked device, US, and CT) for visual information and does not involve use of stereoscopic projection to physical (i.e., real-world) anatomy for navigation, consistent with predicate devices. XR90 (XR90-SYS) spatially registers and stereoscopically co-projects three types of virtual objects: (1) Holographic Light Ray (HLR), (2) CT-based virtual anatomy, and (3) live ultrasound b-sector (Flashlight) with the HUD ultrasound display/augmented reality user interface, while maintaining the same principle of operation compared to predicate devices. Accordingly, the paired registration of holographic entities are:
- (1) HLR and virtual US-sector (Flashlight),
- (2) CT-based virtual anatomy and virtual US-sector (Flashlight), and
- (3) HLR and CT-based virtual anatomy.
The system is comprised of a commercial, off-the-shelf augmented reality head-mounted display, wirelessly connected to a streamer which interfaces with a GE Vivid iq ultrasound system and an electromagnetic (EM) field generator. The US signal is transmitted from the streamer to the headmounted display, where a virtual display of the US image is stereoscopically projected into the user's field-of-view in conjunction with pre-acquired CT-based images and tracked instrumentation.
The XR90 (XR90-SYS) system is capable of teleprocedural collaboration through the head-mounted display using Microsoft Dynamics 365 Remote Assist, allowing for other healthcare professionals to securely connect remotely to the head-mounted display, viewing the US signal and communicating (both through voice and needle annotation on the screen) in real-time with the local proceduralist. The remote collaborator may interact with the proceduralist via mobile device, laptop, desktop, or head-mounted display but the collaborator participates as an observer and should not make care decisions. The combination of teleprocedure communication and Holographic Needle Guide features provide workflow and ergonomics to the user for pre-operative planning and intra-operative display of virtual images. XR90 (XR90-SYS) is intended to be used adjunctively to standard of care imaging and provides guidance to the user. Proceduralists must refer to standard of care (conventional monitors) and prioritize clinical experience and/or judgement when using the XR90 (XR90-SYS) system.
Intended Use
The XR90 (XR90-SYS) is a medical display workstation intended for 3D image visualization and image interaction in conjunction with traditional imaging and monitors. The virtual images are generated from tracked Ultrasound, tracked interventional device, and 3D volumetric data acquired from CT sources and stereoscopically projected such that the proximity of the virtual interventional device is displayed relative to live ultrasound and 3D models from previously acquired CT. The device is intended to provide visual information and reference to be used by the health care professionals for analysis of surgical options during pre-operative planning, and the heads-up, intra-operative display of the images during ultrasoundguided needle-based procedures. Virtual images on the heads-up display should always be used in conjunction with traditional monitors.
The XR90 (XR90-SYS) system is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis.
5
Image /page/5/Picture/0 description: The image contains the logo for MediView. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of curved lines in the colors blue, orange, and green. To the right of the graphic, the company name "MediView" is written in blue, with the words "TRANSFORMATIVE VISION" written in a smaller font size below the company name.
The XR90 (XR90-SYS) system is intended to be used as a reference display for consultation and guidance to assist the clinician who is responsible for making all final patient management decisions.
During system use, the position and orientation tracking of the interventional instruments should always be available to the clinician on traditional imaging and monitors.
The intended use and indications for use are similar to the predicate Real View Imaging Ltd. HOLOSCOPE-i (K210072, referred to as HOLOSCOPE-i throughout this document).
Summary of Technological Characteristics
The XR90 (XR90-SYS) system has a similar intended use and indications for use, principles of operation. and technological characteristics as the legally marketed predicate device, HOLOSCOPE-i (K210072) and the legally marketed reference device, PercuNav Image Fusion and Navigation System (K170716).
- Intended Use: Like HOLOSCOPE-i, the proposed XR90 (XR90-SYS) is a medical display . workstation intended for 3D image visualization and image interaction. Additionally, both devices are intended to be used as a reference display as an adjunct to the interpretation of images performed using legally marketed diagnostic imaging systems and are not intended for primary diagnosis.
- . Intended Users: Like HOLOSCOPE-i, the proposed XR90 (XR90-SYS) is intended to be used by health care professionals who are responsible for making all final patient decisions.
- . Principles of Operation: Like HOLOSCOPE-i, the proposed XR90 (XR90-SYS) receives medical imaging data from standard imaging modalities and generates 3D models to enable the health care professional to visualize the patient's anatomy. Like PercuNav, the proposed XR90 (XR90-SYS) provides image-guided diagnostic and intervention that enables fusion of diagnostic images and pre-procedural reference of tracked instruments to physician-defined targets.
- . Visualization and Navigation: Like the HOLOSCOPE-i, the proposed XR90 (XR90-SYS) provides three-dimensional visualization and image interaction by acquiring data from CT and ultrasound sources to intraoperatively display the images to provide visual information to be used by the health care professional. Similar to the reference device, the proposed XR90 (XR90-SYS) provides real-time, three-dimensional visualization and reference tools for all stages of intervention, including pre-procedure planning and intra-procedural virtual display of images. The system uses transformed two-dimensional patient images into representations that can be fused with live ultrasound.
- Tool Tracking: Both the reference device and XR90 (XR90-SYS) utilize EM tracking to track an ● ultrasound probe and interventional instrument (eTRAX - K092619). Similar hardware is utilized for the EM field generator, cable connection interface, tracked interventional instrument, and micro-EM sensors.
- Registration: Similar to the reference device, the proposed XR90 (XR90-SYS) performs spatial mapping from one image space to another image space (registration), allowing the physician to correlate scan sets with each other and to the tracked instrument.
- o Automatic Registration: The reference device, PercuNav, contains an automatic registration method, in which the ultrasound probe is swept across anatomical landmarks, and then the ultrasound image is registered with the CT images. Similarly, XR90-SYS) contains an automatic registration feature in which a user gazes at each Registration Marker in a sweeping motion, and the system automatically performs the registration of CT-based Holographic Anatomy, ultrasound Flashlight, and tracked interventional instrument using the registration method described in the Device Description and Principles of Operation document.
6
Image /page/6/Picture/0 description: The image shows the logo for MediView. The logo consists of a circular graphic on the left and the word "MediView" on the right. The circular graphic is made up of three curved lines in different colors: orange, blue, and green. Below the word "MediView" is the phrase "TRANSFORMATIVE VISION" in a smaller font.
- Manual Registration: The reference device, PercuNav, contains a manual registration O method in which corresponding points on different imaging modalities are used to translate the images. Similarly, XR90 (XR90-SYS) contains an "Adjustment" feature, in which corresponding points on the CT-based Holographic Anatomy and ultrasound Flashlight are used to translate the CT-based Holographic Anatomy to the real-time ultrasound.
- Proiected Path of Interventional Instrument: The reference device contains a "biopsy" line ● that is aligned with the user-specified target prior to insertion. This is similar to the Holographic Needle Guide and alignment of the Holographic Light Ray with the user-specified target on the Flashlight to be used for pre-operative planning.
- . Targeting Feedback Indicators: The reference device contains an "Ultrasound Guidance Bar" on the right side of the screen that helps detect whether the target is in the ultrasound scanning plane after a target is set. Similarly, the XR90 (XR90-SYS) system contains visual and auditory feedback indicators on in-plane or out-of-plane targeting while aligning the Holographic Light Ray with the Ultrasound Flashlight.
Based on the above comparison, the XR90 (XR90-SYS) has a similar intended use and similar technological and functional features as the predicate device in providing tools and workflows designed to support users with 3D visualization and image interaction with medical device images. Similar to the cited predicate device, XR90 (XR90-SYS) is used for image viewing and interaction both prior to and during procedures.
The XR90 (XR90-SYS) system is substantially equivalent to the predicate device with regards to intended use and technological characteristics and any differences between the XR90 (XR90-SYS) system and the predicate do not introduce new questions of safety or efficacy. Performance testing demonstrates the device performs as intended.
Summary of Performance Data
Verification and validation testing data summarized below were provided in support of the substantial equivalence documentation.
Non-Clinical Performance Testing:
Non-clinical bench testing on the XR90 (XR90-SYS) system was performed to demonstrate the system meets the performance specifications per the device's intended use. The testing concluded that XR90 (XR90-SYS) does not raise any new questions of safety and effectiveness. This included the System Accuracy Verification, Cadaver Study which concluded that the registration and fusion of virtual images was within acceptable limits in a phantom and cadaver model. Additionally, the system performance was evaluated in an animal model. System accuracy performance testing is summarized below:
7
Image /page/7/Picture/0 description: The image shows the logo for MediView. The logo consists of a circular design on the left and the word "MediView" on the right. The circular design is made up of curved lines in different colors, including blue, green, and orange. Below the word "MediView" is the phrase "TRANSFORMATIVE VISION" in a smaller font.
| Test | Mean TRE (mm) | 95% Upper Bound for
TRE (mm) | TRE Measured at Mean
Needle Depth of (cm): |
|---------|---------------|---------------------------------|-----------------------------------------------|
| Phantom | 2.543 mm | 2.726 mm | 7.1 cm |
| Cadaver | 2.293 mm | 2.825 mm | 8.5 cm |
| Animal | 2.9 mm | 3.4 mm | 7.6 cm |
The angular errors, including in-plane and out-of-plane error between the tip of the needle and target was measured in an animal model, and is summarized below:
| Test | Mean Angular Error
(degrees) | 95% Upper Bound
(degrees) |
|-----------------------------|---------------------------------|------------------------------|
| In-plane angular errors | 7.08° | 8.77° |
| Out-of-plane angular errors | 4.79° | 6.50° |
The following non-clinical testing was conducted to evaluate the device:
- Bench testing performance tests demonstrated the system meets its performance requirements by ● verifying the following elements:
- Measurement of Positional Accuracy of the EM Tracking Subsystem in accordance with O ASTM F2554-22
- Accuracy of the system registration, including Target Registration Error and Image O Fusion Registration Error, in a benchtop phantom study and in a cadaver model, as well as measurement validation of distances measured in the system against a ground truth.
- Latency and data communication on the benchtop O
- Registration/image target tracking on the benchtop O
- . Electrical safety was tested in accordance with ANSI AAMI 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.
- Electromagnetic Compatibility (EMC) was tested in accordance with IEC 60601-1- 2:2014 -● Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- . System cleaning and disinfection validation was performed according to AAMI TIR 30:2011/(R)2016, AAMI TIR 12:2010, and FDA guidance:" Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" (March 17, 2015).
- . Sterilization validation according to ISO 11135:2014
- The biocompatibility of all user contact materials was tested according to ISO 10993-1:2018 and ● FDA guidance on the use of ISO 10993-1.
- . Software verification and validation testing was conducted as required by IEC 62304 and FDA guidance on general principles of software validation, January 11, 2002.
8
Image /page/8/Picture/0 description: The image contains the logo for MediView. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of four curved segments in different colors: blue, light blue, orange, and green. To the right of the graphic is the word "MediView" in a blue, sans-serif font. Below "MediView" is the phrase "TRANSFORMATIVE VISION" in a smaller, green, sans-serif font.
-
Usability evaluation the system was validated with intended users in simulated use conditions to ● ensure tasks, including critical tasks, were met and no new issues of safety or effectiveness were raised.
The following performance testing was also conducted to evaluate the device: -
The XR90 (XR90-SYS) system was verified and validated in a GLP porcine study that evaluated ● the safety, efficacy, and accuracy (including Target Registration Error and angular errors) of the system when used in adjunct to standard-of-care imaging during ultrasound-guided needle-based procedures in porcine models. Secondary endpoints of the study included evaluating overall procedure time, complications, and overall clinical usability.
Substantial Equivalence Conclusion
MediView XR maintains that the subject device is substantially equivalent to the legally marketed predicate based on the comparison information provided above and further extrapolated in the substantial equivalence comparison table below. Verification testing, including system level tests, and safety tests established the performance, functionality, and reliability characteristics of the system. It is concluded that the XR90 (XR90-SYS) system is substantially equivalent to the legally marketed predicate device (K210072).
9
Image /page/9/Picture/0 description: The image contains the logo for MediView. The logo consists of a circular design with overlapping segments in shades of blue, green, and orange on the left. To the right of the circular design is the word "MediView" in a teal sans-serif font, with the words "TRANSFORMATIVE VISION" in a smaller teal font below it.
Substantial Equivalence Table
The table below outlines the similarities and differences between the subject XR90 (XR90-SYS) system and the predicate Real View Inaging Ltd. HOLOSCOPE-i system, in addition to the Philips PercuNav Image Fusion and Interventional Navigation as a reference device.
| | Subject Device:
MediView XR90 (XR90-
SYS) System (K223125) | Predicate Device: Real View
Imaging Ltd.
HOLOSCOPE-i (K210072) | Reference Device:
Philips PercuNav Image
Fusion and Interventional
Navigation System
(K170716) | Explanation of
Differences |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Number | K223125 | K210072 | K170716 | N/A |
| Product Code(s) | LLZ | LLZ | JAK/IYO/LLZ | Equivalent to predicate device. |
| Regulation | Medical Image Management and
Processing System (21 CFR
892.2050) | Medical Image Management and
Processing System (21 CFR
892.2050) | Computed Tomography X-Ray
System (21 CFR 892.1750) | |
| Intended Use | The XR90 (XR90-SYS) is a
medical display workstation
intended for 3D image
visualization and image
interaction in conjunction with
traditional imaging and monitors.
The virtual images are generated
from tracked Ultrasound, tracked
interventional device, and 3D
volumetric data acquired from
CT sources and stereoscopically
projected such that the proximity
of the virtual interventional
device is displayed relative to
live ultrasound and 3D models
from previously acquired CT.
The device is intended to provide
visual information and reference
to be used by the health care | The HOLOSCOPE-i is a medical
display workstation intended for
3D image visualization and image
interaction. The holograms are
generated from 3D volumetric
data acquired from CT and
Ultrasound sources. The device is
intended to provide visual
information to be used by the
health care professional for
analysis of surgical options, and
the intraoperative display of the
images. The HOLOSCOPE-i is
intended to be used as an adjunct
to the interpretation of images
performed using diagnostic
imaging systems and is not
intended for primary diagnosis.
The HOLOSCOPE-i is intended | The PercuNav system is a
stereotaxic accessory for
computed tomography (CT),
magnetic resonance (MR),
ultrasound (US), and positron
emission tomography (PET). CT,
Ultrasound, PET, and MR may
be fused in various
combinations, such as CT with
MR, MR with ultrasound, and so
on. It may include
instrumentation to display the
simulated image of a tracked
insertion tool such as a biopsy
needle or probe on a computer
monitor screen that shows
images of the target organs and
the current and the projected
future path of the interventional | There are no fundamental
differences in the intended use
of the XR90 (XR90-SYS)
system compared to the
predicate device.
• The XR90 (XR90-SYS)
system is not an accessory to
imaging modalities, but rather,
indicated to be used
adjunctively to ultrasound.
Ultrasound images may be
fused with previously acquired
CT imaging, whereas the
reference allows for fusion in
various combinations. |
| Subject Device:
MediView XR90 (XR90-
SYS) System (K223125) | Predicate Device: Real View
Imaging Ltd.
HOLOSCOPE-i (K210072) | Reference Device:
Philips PercuNav Image
Fusion and Interventional
Navigation System
(K170716) | Explanation of
Differences | |
| professionals for analysis of
surgical options during pre-
operative planning, and the
heads-up intra-operative display
of the images during ultrasound-
guided needle-based procedures.
Virtual images on the heads-up
display should always be used in
conjunction with traditional
monitors.
The XR90 (XR90-SYS) system
is intended to be used as an
adjunct to the interpretation of
images performed using
diagnostic imaging systems and
is not intended for primary
diagnosis.
The XR90 (XR90-SYS) system
is intended to be used as a
reference display for consultation
and guidance to assist the
clinician who is responsible for
making all final patient
management decisions.
During system use, the position
and orientation tracking of the
interventional instruments should
always be available to the
clinician on traditional imaging
and monitors. | to be used as a reference display
for consultation to assist the
clinician who is responsible for
making all final patient
management decisions. | instrument. The PercuNav
system is intended for treatment
planning and guidance for
clinical, interventional, or
diagnostic procedures.
The PercuNav system also
supports an image-free mode in
which the proximity of the
interventional device is
displayed relative to another
device. The PercuNav system is
intended to be used in
interventional and diagnostic
procedures in a clinical setting.
The PercuNav system is also
intended for use in clinical
interventions to determine the
proximity of one device relative
to another.
Example procedures include, but
are not limited to, the following:
• Image fusion for diagnostic
clinical examinations and
procedures
• Soft tissue biopsies (liver, lung,
kidney, breast, pancreas, bladder,
adrenal glands, lymph node,
mesentery, and so on.)
• Soft tissue ablation (liver,
kidney, breast, pancreas, lung,
and so on)
• Bone ablations
• Bone biopsies | • The XR90 (XR90-SYS)
system utilizes a head-
mounted display for viewing
imaging in augmented reality
(AR), as opposed to the
predicate, which uses an
optical unit attached to a
boom.
• XR90 (XR90-SYS) is a
supplement to live imaging in
clinical interventions and is
not meant to replace standard
of care imaging.
• Similar to the reference,
XR90 (XR90-SYS) is not
intended to be the sole
guidance for any procedure.
Philips also included this
statement in a more recent
510(k) submission for their
PercuNav device (K201053),
so this is similar in both
devices.
The differences in intended
use between the predicate and
XR90 (XR90-SYS) do not
affect the safety or efficacy of
the device, as each have
similar underlying technology
and basic components. | |
| | Subject Device:
MediView XR90 (XR90-
SYS) System (K223125) | Predicate Device: Real View
Imaging Ltd.
HOLOSCOPE-i (K210072) | Reference Device:
Philips PercuNav Image
Fusion and Interventional
Navigation System
(K170716) | Explanation of
Differences |
| | | | • Nerve blocks and pain
management
• Drainage placements
• Tumor resections | |
| Intended Use
Environment | Hospital operating rooms and
procedure rooms | Interventional suites, hybrid
operating rooms, and diagnostic
clinics | Hospital operating rooms,
outpatient surgery centers and
procedure rooms | Similar to the predicate. XR90
(XR90-SYS) is not intended to
be used in diagnostic clinics,
as the EM field generator is
designed to be compatible
with tables found in operating
or procedure rooms. |
| Main System
Components | • EM Field Generator
• Tool Connection Unit
(SCU/SIU)
• Computing Hardware
(Server/Router)
• Microsoft HoloLens 2 head-
mounted display configured with
XR90 (XR90-SYS) Software
• Instrumentation [see 'Tracking'
below] | • Optical Unit
• Computing Hardware
• Cart and boom mechanical
fixture to mechanically connect
the Optical Unit and system
computer
• 3D Control Device | • EM Field Generator
• Tool Connection Unit (TCU)
• Computing Hardware
• Monitor to display PercuNav
Software
• Instrumentation [see 'Tracking'
below] | XR90 (XR90-SYS) uses a
Microsoft HoloLens 2 to
display imaging and tracked
instrumentation for pre-
operative planning and intra-
operative display of virtual
images, as opposed to the
predicate device, which
utilizes an optical unit
connected to a boom
mechanical fixture.
Predicate device uses a 3D
Control Device for interaction,
while XR90 (XR90-SYS) is
"hands-free," using voice and
hand gestures. |
| | Subject Device:
MediView XR90 (XR90-
SYS) System (K223125) | Predicate Device: Real View
Imaging Ltd.
HOLOSCOPE-i (K210072) | Reference Device:
Philips PercuNav Image
Fusion and Interventional
Navigation System
(K170716) | Explanation of
Differences |
| Modes of Operation | • On a head-mounted display, the
interaction with the software is
performed using hand gestures.
Voice commands are optional for
further interaction with the
software.
• Ultrasound parameters may be
changed on the local US system,
not in the XR90 (XR90-SYS)
software.
There are different viewing
options for the US imaging,
including:
• Heads-Up Display (HUD)
• Registered Holograms (In-situ
Flashlight Mode registered with
CT-based models and tracked
instrumentation) | • 3D Control Device is used for
interfacing with the hologram.
• 3D volumetric data is received
from CT or US and generates a
hologram in the holographic
display.
• Spatial Light Modulator (SLM)
is used to generate holograms and
guided to the desired projection
area via the optical system
adjacent to the SLM. | • The viewing of imaging and
tracked instrumentation is
displayed on a computer monitor
screen.
• CT, Ultrasound, PET, and MR
may be fused in various
combinations, such as CT with
MR, MR with ultrasound, and so
on. | The principles of operation
between the subject and
predicate device are similar at
the core: A proceduralist is
viewing fused imaging on a
computer screen, whether via
a traditional monitor or head-
mounted display. Each system
has different modes of
viewing information.
XR90 (XR90-SYS) uses hand
gestures and voice commands
for interaction rather than
interaction with a 3D control
device. |
| Patient Contacting
Components | Registration Markers | None | Patient Tracker | Equivalent to reference
device. Both use skin-
contacting components that
are EM-sensor equipped. |
| Tracking | • EM Tracking
• Registration Markers
• Ultrasound Tracker
• Tracked Interventional
Instrument (Biopsy and RFA
Introducers, including eTrax,
which has been cleared and | | • EM Tracking
• Patient Tracker
• Ultrasound Tracker
• Coaxial Needle Tracker (CNT)
• Adaptive Needle Tracker
(ANT)
• Button Probes | Both the reference and
proposed systems have sensor-
equipped instrumentation to
track the ultrasound and
interventional instrument
within the tracking
environment. |
| | Subject Device:
MediView XR90 (XR90-
SYS) System (K223125) | Predicate Device: Real View
Imaging Ltd.
HOLOSCOPE-i (K210072) | Reference Device:
Philips PercuNav Image
Fusion and Interventional
Navigation System
(K170716) | Explanation of
Differences |
| | marketed by CIVCO Medical
[K092619])
Registration Markers contain an
optical image for registration
only. | | • Biopsy and RFA Introducers
(including eTrax, which has been
cleared and marketed by CIVCO
Medical [K092619]) | The Registration Markers do
not track the patient in real-
time—they are intended to
assist in the registration of
CT-based images with
ultrasound and tracked
interventional instrument. The
PercuNav Patient Tracker
tracks the patient movement. |
| Imaging Modality | Ultrasound, historical segmented
CT images | CT and Ultrasound sources | Ultrasound, CT, MR, PET | None. |
| Registration Method | • Automatic Registration
• Manual registration | | • Automatic Registration
• Manual Registration | Equivalent to reference
device. |
| Medical Device
Interfaces | • GE Vivid iq Premium
Edition Ultrasound system
• Compatible ultrasound probes
• CIVCO eTRAX [K092619]
• GE Omega V Angio table | • Compatible 3D ultrasound
system | • Compatible ultrasound system
• Compatible ultrasound probes
• CIVCO eTRAX [K092619] | The XR90 (XR90-SYS)
system and the predicate both
interface with a compatible
ultrasound system via direct
connection. The XR90 (XR90-
SYS) system has similar
medical device interfaces to
the reference device. The EM
Field Generator is attached to
compatible procedure tables
using custom table brackets,
whereas the EM Field
Generator for PercuNav is
mounted on an arm that is
placed above the patient. |
| Display Features | • 3D models of segmented
images | • Two optical channels, consisting
of a Spatial Light Modulator, an | • 3D view of segmented images | Core technology is equivalent
to the predicate device, in |
| | Subject Device:
MediView XR90 (XR90-
SYS) System (K223125) | Predicate Device: Real View
Imaging Ltd.
HOLOSCOPE-i (K210072) | Reference Device:
Philips PercuNav Image
Fusion and Interventional
Navigation System
(K170716) | Explanation of
Differences |
| | • 2D images: Ultrasound
(Flashlight and Heads-up
Display)
• Trajectories (Holographic Light
Ray)
• Trajectory Guidance
(Holographic Needle Guide)
• Virtual instrument's tip view
(Light Ray)
• 3D transparent (semi-
translucence of 3D models)
• 3D Off (only 2D)
• 3D follow instrument
movement (Light Ray) | RGB coherent light source, a set
of lenses and mirrors to direct
light to the see-through eyepieces. | • 2D images: Ultrasound, CT
(axial, sagittal, coronal), PET,
and MR
• Trajectories (projected future
path of interventional
instrument)
• Trajectory Guidance | which virtual images are
overlaid within the user's
physical environment. The
subject device uses
stereoscopic projection via
see-through diffractive planar
waveguides, while the
predicate uses interference-
based Spatial Light
Modulators.
Reference device and subject
device are equivalent.
Reference device supports
PET and PER/CT, as well as
fusion of two-dimensional
patient images with previously
acquired images. XR90
(XR90-SYS) only supports
fusion of live ultrasound with
previously acquired CT. XR90
(XR90-SYS) does not support
or claim diagnostic review of
images. |
| Software Interface
(GUI) | • Visualization control
(show/hide virtual anatomy &
Flashlight mode)
• Patient Selection/Data Import
• Buttons for registration
• Adjust fusion via Adjustment
method (point-to-point method)
• Software controls for images
• Target selection and planned
trajectory management | • Interactions with system
• Selection of tools
• Drive workflow
This includes the ability to:
• Visualize
• Rotate
• Slice
• Mark
• Measure
images displayed holographically. | • Patient selection/data import
• Select registration method
• Buttons for registration
• Adjust fusion (including point-
to-point method)
• Save registration button
• Software controls for images
• Target selection
• Feedback on target/ultrasound
alignment (Ultrasound Guidance
Bar) | Software interface is similar to
the predicate and reference
device. XR90 (XR90-SYS)
enables a user to visualize
imaging and customize their
display via voice and hand
gestures, similar to the
predicate. Users can mark
locations in the CT-based
Holographic Anatomy and
ultrasound HUD/Flashlight to |
| | Subject Device:
MediView XR90 (XR90-
SYS) System (K223125) | Predicate Device: Real View
Imaging Ltd.
HOLOSCOPE-i (K210072) | Reference Device:
Philips PercuNav Image
Fusion and Interventional
Navigation System
(K170716) | Explanation of
Differences |
| | • Feedback on target/ultrasound
alignment (Light Ray auditory
and visual indicators) | | • Color / MFI / CEUS | perform a CT adjustment.
XR90 (XR90-SYS) registers
images with one another,
whereas the predicate does not
perform registration.
Therefore, image rotation is
not a capability of XR90
(XR90-SYS). |
| Communication Between
Imaging and Computing
Hardware | • DICOM images imported for
segmentation through hospital-
approved USB, CD, or DVD.
• Real-time ultrasound connected
via Ethernet cable to router. | • PACS, USB, or direct from
connected compatible 3D
ultrasound acquisition modality. | • CT, MR, PET images imported
using USB, CD, DVD, or PACS.
• Real-time US connected to
PercuNav. | Similar. XR90 (XR90-SYS)
does not integrate with a
PACS system due to the
segmentation process that
DICOM images must undergo
prior to a procedure with the
device. |
| Communication Between
Headset and Computing
Hardware | Wireless
Streaming hardware (MediView
Streamer and MediView Router)
transmits US imaging from the
scanner to the headset over LAN | Embedded PC supporting system | No Headset | Subject device uses a local
area network (LAN) to
transmit streamed US data to
headset, whereas the predicate
device has a PC supporting
system embedded into the
system, which connects to the
optical unit.
Reference device uses a
computer monitor screen
rather than a head-mounted
display for imaging. |
| | Subject Device:
MediView XR90 (XR90-
SYS) System (K223125) | Predicate Device: Real View
Imaging Ltd.
HOLOSCOPE-i (K210072) | Reference Device:
Philips PercuNav Image
Fusion and Interventional
Navigation System
(K170716) | Explanation of
Differences |
| Display and Optics
Technology | Stereoscopic Holographic
Display using near eye see-
through holographic
lenses/waveguides (Microsoft
HoloLens 2) | Stereoscopic Holographic Display
using a near eye see-through
display (Custom Optical Unit) | Data displayed on a monitor | Equivalent.
Reference device uses a
computer monitor screen
rather than a head-mounted
display for imaging. The
HoloLens 2 head-mounted
display is like a computer
monitor, as it is a see-through
computer display that runs on
Windows 10 Holographic
Operating System. |
| DICOM Compatible | Yes | Yes | Yes | None |
| Original 2D/3D image
remains visible
(acquisition data source) | Yes (ultrasound) | Yes | Yes | None |
10
Image /page/10/Picture/0 description: The image contains the logo for MediView. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of three curved lines in the colors blue, orange, and green. The company name, "MediView," is written in blue, and below it, the words "TRANSFORMATIVE VISION" are written in a smaller, lighter blue font.
11
T
Image /page/11/Picture/1 description: The image contains the logo for MediView. The logo consists of a circular graphic on the left and the text "MediView" on the right. Below "MediView" is the text "TRANSFORMATIVE VISION" in a smaller font. The circular graphic is made up of curved lines in different colors, including blue, orange, and green.
12
Image /page/12/Picture/1 description: The image shows the logo for MediView. The logo consists of a circular graphic on the left, made up of curved segments in blue, orange, and green. To the right of the graphic is the word "MediView" in a blue, sans-serif font. Below "MediView" are the words "TRANSFORMATIVE VISION" in a smaller, sans-serif font.
13
Г
Image /page/13/Picture/1 description: The image shows the logo for MediView. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of four curved lines in different colors: blue, orange, teal, and green. To the right of the graphic, the word "MediView" is written in blue, and below that, the words "TRANSFORMATIVE VISION" are written in a smaller font.
14
w
Medi
TRANSFORMATIVE VISION
15
W
TRANSFORMATIVE VISION
16
W
ME
TRANSFORMATIVE VISION