Centricity Universal Viewer
Device Facts
| Record ID | K182419 |
|---|---|
| Device Name | Centricity Universal Viewer |
| Applicant | GE Healthcare |
| Product Code | LLZ · Radiology |
| Decision Date | Dec 14, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | AI/ML, Software as a Medical Device |
Indications for Use
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies.
Device Story
Centricity Universal Viewer is an internet-based PACS software for radiologists and cardiologists. It accepts, transfers, displays, stores, and processes medical images (CT, MR, US, NM, CR, MG, DX, PET/PT, XA, IO, RF, SC, VL) via DICOM. It integrates with third-party devices, including Tomtec-Arena for advanced cardiology. Deployed on conventional TCP/IP networks using standard computer platforms. Provides tools for image viewing, analysis, and diagnostic interpretation. Features include stenosis analysis, left ventricular analysis, catheter calibration, and distance measurement. Healthcare providers use the viewer to access patient studies, perform measurements, and review images to support clinical decision-making. Benefits include streamlined diagnostic workflows and improved access to multi-modality imaging data.
Clinical Evidence
Bench testing only. No clinical data. Verification and validation included system-level requirements testing, regression testing, integration/interoperability testing, unit testing, usability (formative and summative) testing, and cybersecurity analysis.
Technological Characteristics
Software-based PACS; runs on standard PC hardware/OS (Windows 10, 7, 8.1). Connectivity via TCP/IP; supports DICOM SOP classes. Features include multi-modality hanging protocols, image processing (MIP/MPR), and measurement tools. Cybersecurity includes user authentication via Active Directory and security hardening. Software is classified as moderate level of concern.
Indications for Use
Indicated for authorized healthcare professionals to view, analyze, interpret, and share medical images and data from various imaging and healthcare information sources. Contraindicated for lossy compressed mammographic images and digitized film screen images for primary diagnostic interpretation.
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
- Centricity Universal Viewer (K150420)
Reference Devices
Submission Summary (Full Text)
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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 Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in blue.
December 14, 2018
GE Healthcare Renee Webb Senior Regulatory Affairs Manager 500 West Monroe Street CHICAGO, IL 60661
Re: K182419
Trade/Device Name: Centricity Universal Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 20, 2018 Received: September 26, 2018
Dear Renee Webb:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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.
Hole 2. Nils
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
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# Indications for Use
510(k) Number (if known) K182419
Device Name Centricity Universal Viewer
#### Indications for Use (Describe)
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals.
Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies.
Contraindications:
Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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Image /page/3/Picture/0 description: The image shows the logo for GE Healthcare. On the left is the GE logo, which is a blue circle with the letters "GE" in white. To the right of the logo is the text "GE Healthcare" in black. The text is in a sans-serif font and is aligned to the left.
# 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
#### SUBMITTER l.
GE Healthcare 500 West Monroe Chicago, IL 60661
Primary Contact Person: Renee Webb Senior Regulatory Affairs Manager GE Healthcare Phone: 847-707-8783
| Secondary Contact Person: | John Manarik |
|---------------------------|----------------------------|
| | Regulatory Affairs Manager |
| | GE Healthcare |
| | Phone: 224-532-0907 |
Date Prepared: December 12, 2018
## II. DEVICE
| Name of Device: | Centricity Universal Viewer |
|----------------------|------------------------------------------------------------|
| Common Name: | Picture Archiving and Communication System |
| Classification Name: | 21 CFR 892.2050, System, Image Processing,<br>Radiological |
| Regulatory Class: | II |
| Product Code: | LLZ |
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Image /page/4/Picture/0 description: The image shows the logo for GE Healthcare. The logo consists of the GE logo on the left and the words "GE Healthcare" on the right. The GE logo is a blue circle with the letters "GE" in white inside.
#### III. PREDICATE DEVICE
Primary - K150420 (May 2015)- Centricity Universal Viewer by GE Healthcare Reference - K063628 (December 2006) -Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy.
## IV. DEVICE DESCRIPTION
Centricity Universal Viewer is an Internet based medical image display and interpretation software product that is part of a picture archiving and communications system that assists radiologists and cardiologists in their diagnostic workflows. It provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).
Centricity Universal Viewer provides APIs (Application Program Interfaces) to integrate with third-party medical devices and non-medical devices, which include integration with Tomtec-Arena ™ [1] for advanced cardiology applications.
Centricity Universal Viewer supports DICOM SOP classes to access and manage medical imaging studies from Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Nuclear Medicine (NM), Computerized Radiography (CR), Digital mammoaraphy (MG), Digital X-ray (DX), Positron Emission Tomoaraphy (PET/PT), X-Ray Angiography (XA), Digital Intra-oral X-Ray (IO), Radiofluoroscopic X-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic and Photographic Image Storage, Slide Coordinates Microscopic Image Storage, Presentation States (PS), Key Image Notes (KIN), and other DICOM imaging modalities.
Centricity Universal Viewer is not intended for the diagnosis of digital pathology images.
Centricity Universal Viewer is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms and operating systems.
The system does not produce any original medical images. All images located on the Centricity Universal Viewer have been received from DICOM compliant modalities and/or image acquisition systems.
<sup>[1]</sup> Tomtec-Arena™ K132544 has been FDA cleared and CE Marked.
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Image /page/5/Picture/0 description: The image shows the logo for GE Healthcare. The logo consists of the GE monogram enclosed in a circular design with swirling lines, colored in blue. To the right of the monogram is the text "GE Healthcare" in a simple, sans-serif font, with "GE" in a slightly larger font size than "Healthcare".
## V. INDICATIONS FOR USE
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals.
Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Mammoaraphy images may only be interpreted using a monitor compliant with requirements of local requlations and must meet other technical specifications reviewed and accepted by the local requlatory agencies.
#### Contraindications:
Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
The Intended Use / Indications for Use statement is identical to the Predicate device.
# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject Centricity Universal Viewer device continues to support the display, storage, analysis and processing of various medical images using similar technology.
The basis for this premarket notification is a modification of the legally marketed Centricity Universal Viewer device to incorporate additional features. These modifications do not change the Intended Use. These changes include enhancements and other updates to support customer feedback and to enhance usability of the software application. These modifications improve on the subject device's ability to assist healthcare professionals in the display, storage, processing, and diagnostic analysis of various medical images similarly to the predicate Centricity Universal Viewer.
The Centricity Universal Viewer architecture and SOUP software and software core algorithms have not changed. The Cath Tools algorithm has not changed. Cath Tools adds functionality that already existed in K063628 onto the Centricity Universal Viewer software technology stack.
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Image /page/6/Picture/1 description: The image shows the logo for GE Healthcare. The logo consists of a blue circular emblem with a stylized "GE" inside, followed by the text "GE Healthcare" in black. The text is positioned to the right of the emblem and is written in a clear, sans-serif font.
The following table contains a comparison of the key changes since the last 510k clearance K150420:
| Feature | Predicate Device<br>Centricity Universal<br>Viewer<br>(K150420) | Subject Device<br>Centricity Universal<br>Viewer<br>with Cath Tools | Discussion of<br>Differences |
|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications For<br>Use | Centricity Universal<br>Viewer is a device that<br>displays medical images<br>and data from various<br>imaging sources, and<br>from other healthcare<br>information sources.<br>Medical images and data<br>can be displayed,<br>communicated, stored,<br>and processed.<br>Typical users of this<br>system are authorized<br>healthcare professionals.<br>Centricity Universal<br>Viewer is intended to<br>assist in the viewing,<br>analysis, diagnostic<br>interpretation, and<br>sharing of images and<br>other information.<br>Mammography images<br>may only be interpreted<br>using a monitor<br>compliant with<br>requirements of local<br>regulations and must<br>meet other technical<br>specifications reviewed<br>and accepted by the<br>local regulatory<br>agencies. | Identical to<br>predicate device | No change |
| Contraindication | Centricity Universal Viewer<br>is contraindicated for the<br>use of lossy compressed<br>mammographic images. | Identical to<br>predicate device | No change |
| Feature | Predicate Device<br>Centricity Universal<br>Viewer<br>(K150420) | Subject Device<br>Centricity Universal<br>Viewer<br>with Cath Tools | Discussion of<br>Differences |
| | Lossy compressed<br>mammographic images<br>and digitized film screen<br>images must not be<br>reviewed for primary image<br>interpretations. | | |
| Cath Analysis<br>Tools | Not supported | Supported in the<br>subject device.<br>The following tools<br>are available to help<br>perform an analysis<br>of images received<br>as a result of a<br>catheterization<br>procedure:<br>1. Stenosis Analysis<br>2. Left ventricular<br>analysis<br>3. Catheter<br>calibration<br>• Point to Point<br>Calibration<br>• Calibration<br>extension<br>4. Distance<br>measurement | Equivalent. Cath<br>Tools modifications<br>do not change the<br>Intended Use. The<br>Cath Tools<br>functionality added is<br>identical to the Cath<br>Tools in GE<br>Healthcare's,<br>Centricity Radiology<br>RA600, Cardiology<br>CA1000 cleared<br>under K063628. Test<br>results for these<br>modifications do not<br>raise different issues<br>of safety or<br>effectiveness. There<br>are no new potential<br>hazards and no<br>changes to existing<br>potential hazards,<br>and no change in the<br>final risk ratings for<br>the device. |
| Workflow | | | |
| Interactive<br>search for<br>studies | Search by:<br>1. Patient name<br>2. ID<br>3. Accession Number<br>4. Study date<br>5. Study description<br>6. Modality<br>7. Study status<br>8. Referring Physician<br>9. Date of Birth<br>10. Referring Service | Same as predicate,<br>except:<br>- Retrieval of off-<br>line study<br>- Access to<br>confidential<br>patient studies<br>based on<br>privileges<br>- Increase number<br>of studies the | Equivalent. Adding<br>the modifications<br>under interactive<br>search for studies<br>does not impact the<br>device safety and<br>effectiveness. |
| Feature | Predicate Device<br>Centricity Universal<br>Viewer<br>(K150420) | Subject Device<br>Centricity Universal<br>Viewer<br>with Cath Tools | Discussion of<br>Differences |
| | 11. Priority<br>12. Online status (CPACS<br>only)<br>13. 0 image studies<br>(CPACS only)<br>14. Performing physician<br>15. Location (Enterprise<br>Archive (EA) only for<br>Cardiology) | worklist can<br>display and<br>remove 30 study<br>limit on custom<br>worklists<br>- Support for<br>Technologist<br>study verification<br>workflow and<br>teaching folder<br>- Create, access,<br>save and display<br>key images | |
| Search from<br>DICOM server | Search for studies<br>located on the external<br>DICOM compliant server.<br>Supported only on IW<br>backend | Same as predicate,<br>except:<br>- search and<br>retrieve prior<br>exams from<br>external DICOM<br>server<br>- save and display<br>DICOM grayscale<br>presentation<br>state object to<br>work with any<br>type of under-<br>lying hanging<br>protocol | Equivalent. Adding<br>the modifications<br>under the search<br>from DICOM server<br>does not impact the<br>device safety and<br>effectiveness. |
| Image Display | | | |
| Ability to display<br>information | Ability to display the<br>following:<br>1. Image<br>2. Report<br>3. Patient information<br>4. Exam information<br>5. DICOM Header<br>information<br>6. GSPS<br>7. RPPS<br>8. FCE<br>9. Key Image Notes<br>10. Exam Notes | Same as predicate,<br>except:<br>- native support of<br>diagnostic<br>interpretation for<br>2D and DBT<br>mammo images<br>- user, group and<br>system level step<br>protocols<br>- support DICOM<br>metadata in<br>overlay / | Equivalent. These<br>modifications do not<br>change the Intended<br>Use. The device<br>continues to support<br>the display, storage,<br>analysis and<br>processing of various<br>medical images using<br>a similar technology.<br>Test results for these<br>modifications do not<br>raise different issues |
| Feature | Predicate Device<br>Centricity Universal<br>Viewer<br>(K150420) | Subject Device<br>Centricity Universal<br>Viewer<br>with Cath Tools | Discussion of<br>Differences |
| | 11. Modality and VOI LUT<br>12. Structured Reports | annotation editor<br>- support<br>synchronized ECG<br>curve, ECG scroll<br>and ECG curve<br>height selector<br>- support Dorsal<br>view (Reverse<br>ACR IHE) for<br>mammography | of safety or<br>effectiveness. There<br>are no new potential<br>hazards and no<br>changes to existing<br>potential hazards,<br>and no change in the<br>final risk ratings for<br>the device. |
| Image<br>Annotations and<br>measurements | 1. Line<br>2. Angle<br>3. SUV<br>4. OB Measurements<br>5. Digital Subtraction<br>Angiography (DSA)<br>6. Triangulation<br>7. MIP/MPR<br>8. Spine Labeling<br>9. Using "imager pixel<br>spacing" - DICOM field to<br>enable measurements<br>across all CR/DX/US<br>exams.<br>10. Cardio Thoracic Ratio<br>(CTR)<br>11. Image Annotations | Same as predicate,<br>except:<br>- Automatically<br>mark images as<br>key when image is<br>annotated<br>- Use "imager pixel<br>spacing" DICOM<br>field to enable<br>measurements<br>across CR/DX/US<br>exams | Equivalent. Adding<br>the modifications for<br>image annotations<br>and measurements<br>does not impact the<br>device safety and<br>effectiveness. These<br>enhancements<br>provide information<br>already available to<br>be used in the same<br>way as the predicate,<br>for the same purpose<br>and by the same<br>users. |
| Customized<br>Hanging<br>Protocols | Smart Reading Protocols<br>-Regular Hanging<br>protocols to launch<br>multiple MIP/MPRs | Same as predicate,<br>except:<br>- multi-modality and<br>multi-vendor<br>hanging protocol<br>- dedicated toolbar<br>for mammography<br>features<br>- smart reading<br>protocols learn<br>user's preferences<br>for MRI<br>multiphasic<br>studies | Equivalent. Adding<br>the modifications for<br>customized hanging<br>protocols does not<br>impact the device<br>safety and<br>effectiveness. These<br>enhancements<br>provide information<br>to be used in the<br>same way as the<br>predicate, for the<br>same purpose and by<br>the same users. |
| Maximum<br>Intensity | Maximum Intensity<br>Projection (MIP) MIP with | Same as predicate,<br>except: | Equivalent. These<br>modifications do not |
| Feature | Predicate Device<br>Centricity Universal<br>Viewer<br>(K150420) | Subject Device<br>Centricity Universal<br>Viewer<br>with Cath Tools | Discussion of<br>Differences |
| Projection (MIP)<br>MIP with<br>interactive<br>window-level<br>clipping volume<br>of interest,<br>zoom, pan, and<br>rotate | interactive window-level<br>clipping volume of<br>interest, zoom, pan, and<br>rotate | - Recalculate<br>standard update<br>value on the fly for<br>PET/CT images<br>- Multi-planar<br>reconstruction<br>support multiple<br>oblique<br>reconstruction<br>- Support for non-<br>square pixel image<br>calibration | change the Intended<br>Use. The device<br>continues to support<br>the display, storage,<br>analysis and<br>processing of various<br>medical images using<br>a similar technology.<br>Test results for these<br>modifications do not<br>raise different issues<br>of safety or<br>effectiveness. There<br>are no new potential<br>hazards and no<br>changes to existing<br>potential hazards,<br>and no change in the<br>final risk ratings for<br>the device. |
| Printing | | | |
| Key<br>Images/Print<br>Pages | Created Print Pages from<br>selected Key Images,<br>one-click placement;<br>customized templates;<br>one click-full screen<br>snapshot | Identical to<br>predicate device | No change |
| Print to Film /<br>Paper | Print collage of images to<br>printer | Identical to<br>predicate device | No change |
| Connectivity,<br>Interfaces &<br>Interoperability | | | |
| Integration | Integration COM service | Identical to<br>predicate device | No change |
| Interfaces | Generic interface to<br>integrate outbound with<br>third party applications<br>and internal GEHC<br>applications that meet<br>the interface<br>requirements. | Same as predicate,<br>except:<br>- Update to API<br>connectivity to<br>launch newer<br>versions of 3rd<br>party software | Equivalent. Adding<br>modifications for the<br>interfaces does not<br>impact the device<br>safety and<br>effectiveness. There<br>are no new potential<br>hazards. |
| Feature | Predicate Device<br>Centricity Universal<br>Viewer<br>(K150420) | Subject Device<br>Centricity Universal<br>Viewer<br>with Cath Tools | Discussion of<br>Differences |
| | | applications such<br>as GE Healthcare's<br>EchoPAC and<br>Advantage<br>Workstation<br>applications | hazards and no<br>changes to existing<br>potential hazards,<br>and no change in the<br>final risk ratings for<br>the device. |
| External system<br>launch | The viewer can be<br>launched via a 3rd party<br>application using the<br>following methods:<br>1. url launch<br>2. IVAPI<br>3. Inbound API | Same as predicate,<br>except:<br>- Updates in<br>interfaces with 3rd<br>party software<br>applications<br>- URL launch using<br>SUID when study<br>associated with<br>multiple orders | Equivalent. Adding<br>modifications under<br>external system<br>launch does not<br>impact the device<br>safety and<br>effectiveness. These<br>enhancements<br>provide information<br>to be used in the<br>same way as the<br>predicate, for the<br>same purpose and by<br>the same users. |
| Administrative | | | |
| Interactive<br>query | In console, supporting<br>wildcards | Identical to<br>predicate device | No change |
| Setup | Wizard and silent | Identical to<br>predicate device | No change |
| On-line help | Yes | Identical to<br>predicate device | No change |
| User Interface<br>and User<br>Manual<br>Languages | 1. English, 2. German,<br>3. Japanese, 4. French,<br>5. Simplified Chinese<br>6. Italian, 7. Polish, 8.<br>Spanish<br>9. Turkish, 10. Brazilian<br>Portuguese, 11. Dutch,<br>12. Swedish, 13. Russian<br>14. Korean, 15. Finnish,<br>16. Danish, 17.<br>Norwegian,<br>18. Traditional Chinese<br>19. Portuguese, 20.<br>Greek,<br>21. Hungarian | Identical to<br>predicate device | No change |
| Feature | Predicate Device Centricity Universal Viewer (K150420) | Subject Device Centricity Universal Viewer with Cath Tools | Discussion of Differences |
| Administrative rights assignment | Per user/group | Identical to predicate device | No change…
