Who is the manufacturer of IBM iConnect Access?

Merge Healthcare Incorporated filed the 510(k) submission for IBM iConnect Access (K182290).

What is the FDA product code for IBM iConnect Access?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for IBM iConnect Access?

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

What are the predicate devices for IBM iConnect Access?

Cedara Web Access 2.4 (K092915); Zero-Download 3D Solution (K143318).

Who can help prepare an FDA 510(k) submission like IBM iConnect Access?

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.

IBM iConnect Access

K182290 · Merge Healthcare Incorporated · LLZ · Sep 25, 2018 · Radiology

Device Facts

Record ID	K182290
Device Name	IBM iConnect Access
Applicant	Merge Healthcare Incorporated
Product Code	LLZ · Radiology
Decision Date	Sep 25, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including: Displaying DICOM compliant medical images and non-DICOM content using XDS . Reformatting images, including creation of MPRs, MIPS, MinIPs, color/monochrome 3D volume rendered images . Manipulating displayed images via control of slice thickness, slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformations, segmentation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path. . Creating individually captured DICOM images that can be displayed and stored in a PACS . Measuring coronary calcium, which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms. The IBM iConnect Access application can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use.

Device Story

Web-based PACS viewer providing internet access to multi-modality medical images/reports; operates via standard internet browser without local installation. Inputs: DICOM/non-DICOM images, reports, videos, attachments from archives (e.g., IBM iConnect Enterprise Archive). Transforms data via server-side (HTML4) or client-side (HTML5) rendering; supports MPR, MIP, MinIP, 3D volume rendering, and coronary calcium scoring. Used by radiologists, referring physicians, and healthcare personnel in clinical or remote settings. Output: Interactive display of images/data for diagnostic review, planning, and reporting. Affects clinical decision-making by providing visualization and measurement tools; does not provide automated diagnosis. Benefits: Enables remote access to patient data, facilitating efficient review and collaboration.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing confirmed product specifications met design requirements.

Technological Characteristics

Software-based PACS viewer; supports DICOM and XDS. Connectivity: TCP/IP networks. Rendering: Server-side (HTML4) or client-side (HTML5). Platforms: Windows Server 2012 R2/2016, SQL Server 2012/2014/2016, VMware. Browsers: IE 11, Edge, Firefox, Chrome, Safari. Features: MPR, MIP, MinIP, 3D volume rendering, coronary calcium scoring, real-time collaboration, RGB channel filter.

Indications for Use

Indicated for healthcare professionals to conduct diagnostic review, planning, and reporting of multi-modality medical images and patient data. Includes coronary calcium scoring for non-invasive identification/quantification of calcified atherosclerotic plaques. Not for primary interpretation of lossy compressed mammographic or digitized film screen images. Mobile device use is not intended for diagnostic purposes.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Cedara Web Access 2.4 (K092915)
Zero-Download 3D Solution (K143318)

Related Devices

K203104 — IBM iConnect Access · Merge Healthcare Incorporated · Jan 26, 2021
K223048 — Medisystem Pacs · Medilab Manutencao E Sitemas Ltda · Jun 23, 2023
K170434 — Enterprise Imaging XERO Viewer 8.1 · Agfa Healthcare N.V. · Jul 3, 2017
K233226 — FlexView Diagnostic (v1.1.20) · Radical Imaging, LLC · Jan 17, 2024
K203058 — CloudVue · International Medical Solutions, Inc. · Oct 29, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. September 25, 2018 Merge Healthcare Incorporated Tracey Fox Global Regulatory Affairs Program Manager 900 Walnut Ridge Drive HARTLAND, WI 53209 Re: K182290 Trade/Device Name: IBM iConnect Access Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: August 22, 2018 Received: August 23, 2018 Dear Tracey Fox: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Hse 2. Mild for Robert A. 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) K182290 Device Name IBM iConnect Access #### Indications for Use (Describe) The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including: o Displaying DICOM compliant medical images and non-DICOM content using XDS o Reformatting images. including creation of MPRs. MIPS. MinIPs. color/monochrome 3D volume rendered images o Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path. o Creating individually captured DICOM images that can be displayed and stored in a PACS o Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms. The IBM iConnect Access application can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------|------------------------------------------------------------| | <label>Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label>Over-The-Counter Use (21 CFR 801 Subpart C)</label> | | 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}------------------------------------------------ ### 510(k) Summary | Submitter: | Merge Healthcare Incorporated 900 Walnut Ridge Drive Hartland, Wisconsin 53209 USA | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | August 22, 2018 | | Contact Person: | Tracey Fox Global Regulatory Affairs Program Manager Phone: (262) 369-3156 Email: tracey.fox@ibm.com or med.reg.contact@ca.ibm.com | | Secondary Contact: | Meg Mucha Sr. RA/QA Leader Phone: (262) 912-3514 Email: meg.mucha@ibm.com | | Trade Name: | IBM iConnect Access | | Common Name: | Picture Archiving and Communication System (PACS) | | Classification Name: | Radiological Image Processing System 21 CFR 892.2050 | | Product Code: | LLZ | | Device Class: | Class II | | Predicate Devices: | Cedara Web Access 2.4 (K092915) Zero-Download 3D Solution (K143318) | ### Device Description IBM iConnect Access provides healthcare professionals with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP networks. With no application-specific installation required on the user's computer, healthcare professionals can use IBM iConnect Access with a standard internet browser to view studies and patient information including but not limited to the following content: Diagnostic Reports, Key Images, Presentation Series, Modality Imaging, Scope/ Surgery Videos, Visible Light, and File Attachments. {4}------------------------------------------------ IBM iConnect Access was designed with an easy and convenient workflow providing image viewing and manipulation capabilities including but not limited to zoom, pan, window/ level, scroll, cine, link series, line/ angle/ ROI measurements, and MPR. The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user. The IBM iConnect Access 3D advanced imaging solution supports MIP (maximum intensity project). MPR (multiplanar reconstruction). 3D volume rendering, and cardiac calcium scoring. Reading physicians, referring physicians, and other appropriate healthcare personnel can employ advanced image processing and display from local or remote locations. IBM iConnect Access can be used to query retrieve content from the IBM iConnect Enterprise Archive. IBM iConnect Enterprise Archive is a software system that supports storage and communications of medical images and data. Qualified system administrators monitor and maintain the software in their healthcare enterprise environment. IBM iConnect Access along with IBM iConnect Enterprise Archive comprise a cloud based solution marketed as iConnect Cloud Archive. The IBM iConnect Access 3D advanced imaging solution option is not available on iConnect Cloud Archive. # Intended Use/ Indications for Use The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including: - Displaying DICOM compliant medical images and non-DICOM content using XDS . - . Reformatting images, including creation of MPRs, MIPS, MinIPs, color/monochrome 3D volume rendered images - . Manipulating displayed images via control of slice thickness, slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformations, seqmentation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path. - . Creating individually captured DICOM images that can be displayed and stored in a PACS - . Measuring coronary calcium, which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms. Image /page/4/Picture/12 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or atom to the left of the text "Watson Health". The text is in a bold, sans-serif font. There is a green bar above the logo. {5}------------------------------------------------ The IBM iConnect Access application can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use. ### Comparison with Predicate The primary predicate, Cedara Web Access 2.4 cleared under K092915, was rebranded iConnect Access after the full transition of Cedara into Merqe Healthcare. The reference predicate, Zero Download 3D Viewer cleared under K143318 by DR Systems, will now be offered as an option branded, IBM iConnect Access 3D advanced imaging solution. DR Systems was acquired by Merge Healthcare in February 2015. The indications for use of IBM iConnect Access have been expanded to include the indications for use of the IBM iConnect Access 3D advanced imaging solution. Feature enhancements include an RGB channel filter, a real-time collaboration feature, an additional user interface option and other non-significant changes. | Category | Proposed Device IBM iConnect Access | Primary Predicate Cedara Web Access 2.4 | Reference Predicate Zero Download 3D Viewer | Rationale | |-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) Number | TBD | K092915 | K143318 | Information Only | | 510(K) Applicant | Merge Healthcare Incorporated | Cedara Software Company | DR Systems, Inc. | Information Only | | Common Name of Device/ Classification/ Product Code | Picture Archiving and Communications System (PACS) 21 CRF 892.2050 LLZ - Radiological Image Processing System | Picture Archiving and Communications System (PACS) 21 CRF 892.2050 LLZ - Radiological Image Processing System | Digital Image Processing 21 CRF 892.2050 LLZ – Radiological Image Processing System | Information Only | | Intended Use/Indications for Use | The IBM iConnect Access application provides internet access to multi- modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and | Cedara WebAccess 2.4 is a software application that provides internet access to multi- modality softcopy medical images, reports and other patient related | DR Systems Z3D is intended to provide reading physicians, referring physicians, and other appropriate healthcare professionals' tools to aid in interpreting medical images, including: | Substantially Equivalent - Proposed device combines both predicate indications for use with minor | | Category | Proposed Device IBM iConnect Access | Primary Predicate Cedara Web Access 2.4 | Reference Predicate Zero Download 3D Viewer | Rationale | | | manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including: Displaying DICOM compliant medical images and non- DICOM content using XDS Reformatting images, including creation of MPRS, MIPS, MinIPs, color/monochrome 3D volume rendered images Manipulating displayed images via control of slice thickness, slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformations, segmentation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path. Creating individually captured DICOM images that can be displayed and stored in a PACS Measuring coronary calcium, which is intended for non- invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms. The IBM iConnect Access application can be configured to provide either lossless or lossy compressed images for | information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. Cedara WebAccess 2.4 is capable of being configured to | Displaying DICOM compliant medical image volumes, such as CT, MRI, and PET Reformatting images, including creation of MPRs, MIPS, MinIPs, color/monochrome 3D volume rendered images Manipulating displayed images via control of slice thickness, slice interval, obliquity, perspective, rotation, window/level, crop, zoom, color/monochrome transformations, segmentation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path. Creating series of DICOM images and individually captured images that can be displayed and stored in a PACS. Measuring coronary calcium, which is intended for non- invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium | modifications for clarification. Addition of statement that mobile use is not for diagnostic viewing. | | Category | Proposed Device IBM iConnect Access | Primary Predicate Cedara Web Access 2.4 | Reference Predicate Zero Download 3D Viewer | Rationale | | | display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use. | provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. | scoring algorithms. | | | Image Manipulation | Cine Filters: Edge Enhancement for X-ray images RGB channel filter | Image Rotate Image Flip Magnify Invert Image Mirror | Color/Monochrome transformations Tools for Segmentation Auto Draw Centerline Path Definition and Boundary detection | Substantially Equivalent - RGB channel filter added with this release. Edge | | Category | Proposed Device IBM iConnect Access | Primary Predicate Cedara Web Access 2.4 | Reference Predicate Zero Download 3D Viewer | Rationale | | | color/ monochrome transformations Image Rotate Image Flip Magnify Invert Image Mirror Tools for Segmentation Auto Draw Centerline Path Definition and Boundary detection Rotate - Click Center Rotate - Image Center Sculpting - polygon Sculpting - freehand Straightening the display of curved structures Cross-sections perpendicular to and rotation around curved anatomy Crop Control of slice thickness | | Rotate - Image Center Sculpting - polygon Sculpting - freehand Straightening the display of curved structures Cross-sections perpendicular to and rotation around curved anatomy Crop Control of slice thickness | ment and Cine evaluated in previous release as non- significant change. | | Server | Windows Server 2012 R2 Windows Server 2016 SQL Server 2012 SQL Server 2014 SQL Server 2016 Hyper-V Windows Server 2012 R2 and 2016 VMware ESX and Vsphere 5.x and 6.x | Windows Server 2008 R2 Windows Server 2003 R2 SQL Server 2003 SQL Server 2005 | Windows Server 2008 R2 | Substantially Equivalent - compatible with more recent versions. | | User Access | Internet Browser via desktop and mobile (iPad and iPhone) Browsers supported: Microsoft Internet Explorer 11, Microsoft Edge, Mozilla Firefox, Google Chrome, and Apple Safari HTML4 Enterprise viewer support HTML5 Universal viewer support | Internet Browser via desktop and mobile (iPad, IPhone, iPod Touch, Blackberry) Browsers supported: Microsoft Internet Explorer, Mozilla Firefox, Google | Desktop Windows PC & Apple MacIntosh with Microsoft Silverlight 4 or above Browsers supported: Microsoft Internet Explorer, Mozilla Firefox, Google Chrome, and Apple Safari HTML4 viewer support | Substantially Equivalent - compatible with more recent versions. | | Category | Proposed Device IBM iConnect Access | Primary Predicate Cedara Web Access 2.4 | Reference Predicate Zero Download 3D Viewer | Rationale | | | | Chrome, and Apple Safari HTML4 viewer support | | | | Image Rendering | HTML4 Enterprise Viewer: Server side rendering via web browser as JPEG for lossy data and PNG for lossless data HTML5 Universal Viewer: Client side rendering via web browser as JPEG for lossy data and PNG for lossless data | Server side rendering via web browser as JPEG for lossy data and PNG for lossless data | Server side rendering via web browser as JPEG for lossy data and PNG for lossless data | Substantially Equivalent – provides client side rendering for HTML5 | | Images Displayed | DICOM compliant medical image volumes (DICOM conformance statement available on-line) Non-DICOM images (JPG, GIF) | DICOM compliant medical image volumes (DICOM conformance statement available on-line) | DICOM compliant medical image volumes (DICOM conformance statement available on-line) | Substantially Equivalent – IBM iConnect Access includes the ability to display non- DICOM images. | | Collaboration | Real-time collaboration screen viewing | Image Sharing via email…