Who is the manufacturer of Enterprise Imaging XERO Viewer 8.1?

Agfa Healthcare N.V. filed the 510(k) submission for Enterprise Imaging XERO Viewer 8.1 (K170434).

What is the FDA product code for Enterprise Imaging XERO Viewer 8.1?

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

What is the regulatory pathway for Enterprise Imaging XERO Viewer 8.1?

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

What are the predicate devices for Enterprise Imaging XERO Viewer 8.1?

Carestream Health's Vue Motion (K151774); Agfa HealthCare's ICIS View (K143397).

Who can help prepare an FDA 510(k) submission like Enterprise Imaging XERO Viewer 8.1?

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.

Enterprise Imaging XERO Viewer 8.1

K170434 · Agfa Healthcare N.V. · LLZ · Jul 3, 2017 · Radiology

Device Facts

Record ID	K170434
Device Name	Enterprise Imaging XERO Viewer 8.1
Applicant	Agfa Healthcare N.V.
Product Code	LLZ · Radiology
Decision Date	Jul 3, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Agfa HealthCare's Enterprise Imaging XERO Viewer 8.1 is a software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer 8.1 enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multidisciplinary viewer. XERO Viewer 8.1 allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements. When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use. XERO Viewer 8.1 can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.

Device Story

Web-based PACS software; enables multi-specialty medical image/report viewing, annotation, and 3D visualization. Inputs: DICOM medical images/reports from various modalities (CR, DX, CT, MR, US, ECG). Operation: authenticated users access via web browser or iPad (Full Fidelity Mobile); no local installation required. Output: displayed images/data for clinical review and diagnostic decision-making. Used in clinical environments by physicians/surgeons/nurses. Benefits: provides remote/portable access to patient data, facilitating timely clinical decisions when primary workstations are inaccessible.

Clinical Evidence

Bench testing only. No clinical trials performed. Validation included image quality evaluations by qualified radiologists comparing XERO Viewer to Enterprise Imaging 8.0.0 Diagnostic Desktop (K142316) using calibrated diagnostic monitors (5-6 studies per modality). ECG viewing functionality validated on iPad to ensure consistency with desktop performance.

Technological Characteristics

Web-based software application; DICOM compliant. Supports CR, DX, CT, MR, US, ECG. Features 3D visualization, window/level, annotation, and measurement tools. Connectivity: networked via web browser. Standards: ISO 13485, ISO 14971, ISO 27001, ISO 62366, IEC 62304, ACR/NEMA PS3.1-3.20 (DICOM).

Indications for Use

Indicated for reference and diagnostic viewing of multi-specialty medical imaging (CR, DX, CT, MR, US, ECG) and non-imaging data by healthcare professionals (physicians, surgeons, nurses, administrators). Not intended for primary interpretation of lossy compressed mammography or digitized film. Mobile configuration not intended to replace diagnostic workstations.

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

Carestream Health's Vue Motion (K151774)
Agfa HealthCare's ICIS View (K143397)

Reference Devices

Enterprise Imaging 8.0.0 Diagnostic Desktop (K142316)

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Submission Summary (Full Text)

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three human profiles forming the staff of the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 3, 2017 Agfa HealthCare N.V. % ShaeAnn Cavanagh, RAC Regulatory Affairs Manager, North America Agfa HealthCare Corporation 10 South Academy Street GREENVILLE SC 29601 Re: K170434 Trade/Device Name: Enterprise Imaging XERO Viewer 8.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 30, 2017 Received: May 31, 2017 Dear Ms. Cavanagh: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {1}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Robert Ochs Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K170434 ### Device Name Enterprise Imaging XERO Viewer 8.1 ### Indications for Use (Describe) Agfa HealthCare's Enterprise Imaging XERO Viewer 8.1 is a software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer 8.1 enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer. XERO Viewer 8.1 allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements. When images are reviewed and used as an element of diagnosibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use. XERO Viewer 8.1 can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis. | 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}------------------------------------------------ # 510(K) SUMMARY: ## Agfa HealthCare's Enterprise Imaging XERO Viewer #### I. SUBMITTER Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Jodi Coleman, Prepared: February 10, 2017 Telephone: 519-746-6210 ext 2485 #### II. DEVICE Name of Device: Enterprise Imaging XERO Viewer 8.1 Common Name: System, Image Processing, Radiological Classification Name: Picture Archiving and Communications System (PACS) Regulatory Classification: Class II, 21 CFR 892.2050 Product Code: LLZ #### III. PREDICATE DEVICES This is a 510(k) for Agfa's Enterprise Imaging, which is a picture archiving and communications system. It is substantially equivalent to Carestream Health's Vue Motion (K151774) and Agfa HealthCare's ICIS View (K143397). These predicate devices have not been subject to a design-related recall. #### IV. DEVICE DESCRIPTION Enterprise Imaging XERO Viewer is a web based software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents. It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks. XERO Viewer enables authenticated users to search for and display patient studies (reports and images) using a web browser, user's do not need to download or install any additional software or plug-ins to use XERO Viewer. It is the successor to Agfa's ICIS View predicate (K143397) and adds the following new functionality: it adds Xtended study viewing) desktop diagnostic support for additional modalities, supports Xtend 3D visualization and ECG mobile (Full Fidelity) diagnostic support utilizing the newer iPad version. {4}------------------------------------------------ The only difference of the new device and the primary predicate device, Carestream Vue Motion (K151774) is the new device does not support mobile diagnostic viewing on other handheld devices other than an iPad. Differences in devices do not alter the intended diagnostic effect. Principles of operation and technological characteristics of the new and predicate devices are the same. ## INTENDED USE Agfa HealthCare's Enterprise Imaging XERO Viewer 8.1 is a software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer 8.1 enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multidisciplinary viewer. XERO Viewer 8.1 allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements. When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use. XERO Viewer 8.1 can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use. review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis. Intended use has not changed as a result of any labeling modification(s). ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH V. PREDICATE DEVICES Agfa's Enterprise Imaging XERO Viewer has an Indications For Use statement similar to predicate devices (K151774, K143397)). The statements have been combined and simplified. The devices have the same technological characteristics. {5}------------------------------------------------ Both XERO Viewer and the primary predicate device, Carestream Vue Motion (K151774) are used to display medical images for diagnostic purposes of multiple modalities. Both provide wireless and portable access to medical images on select validated mobile devices. Furthermore, XERO Viewer Full Fidelity and Vue Motion contain a statement that it is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer and Vue Motion (K151774) are indicated to allow image manipulations, 3D viewing capabilities and display lossylossless images. Both XERO Viewer and Vue Motion (K151774) require the use of FDA approved display hardware for primary interpretation and review of mammography images. Enterprise Imaging XERO Viewer is a web based software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents. It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks. XERO Viewer enables authenticated users to search for and display patient studies (reports and images) using a web browser, user's do not need to download or install any additional software or plug-ins to use XERO Viewer. It is the successor to Agfa's ICIS View predicate (K143397) and adds the following new functionality: it adds Xtended study viewing) desktop diagnostic support for additional modalities, supports Xtend 3D visualization and ECG mobile (Full Fidelity) diagnostic support utilizing the newer iPad version. The only difference of the new device and the primary predicate device, Carestream Vue Motion (K151774) is the new device does not support mobile diagnostic viewing on other handheld devices other than an iPad. Differences in devices do not alter the intended diagnostic effect. The devices have the same technological characteristics. The new device and the predicate devices (K151774, K143397) are picture archiving and communication systems (PACS), Product Code LLZ. Agfa's XERO Viewer system is substantially equivalent to the predicate devices (K151774, K143397) in that it uses precisely the same technology to capture and display medical data. Descriptive characteristics and performance data including image quality evaluations by qualified radiologists are adequate to ensure equivalence. Differences in devices do not alter the intended therapeutic/diagnostic effect. Table 1 on the next page summarizes the similarities and differences between the new device and predicates. {6}------------------------------------------------ | | Enterprise Imaging XERO Viewer NEW DEVICE | Carestream Vue Motion (K151774) PRIMARY PREDICATE | Agfa HealthCare's ICIS View (K143397) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Communication | Same as predicates | DICOM | DICOM | | Modalities | Including CR, DX, CT, MR, US, ECG | Including CR, DR, CT, MR, NM, US, ECG | CR, DX, CT, MR, US | | Modalities Full Fidelity Mobile Diagnostic | CR, DX, CT, MR, US, ECG | Including CR, DR, CT, MR, NM, US, ECG | CR, DX, CT, MR, US | | Mammography Use | Same as primary predicate | Yes | No | | Mobile Device Support for Diagnostic Viewing | iPads | iPads, iPhones, Galaxy Note, Galaxy S | iPads | | Transfer/Storage/Display of Medical Images | Same as predicates | Yes | Yes | | Network Access | Web browser connects to existing PACS | Web browser connects to existing PACS | Web browser connects to existing PACS | | User Authentication | Same as primary predicate | Yes | Yes | | Window Level | Same as primary predicate | Yes | Yes | | Rotate/Pan/Zoom | Same as primary predicate | Yes | Yes | | Measurement | Same as primary predicate | Yes | Yes | | Annotation | Same as primary predicate | Yes | Yes | | 3D Visualization | Same as primary predicate | Yes | No | | Indications for Use | Software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data with associated reports and documents and, as such, fulfills a key role in the Enterprise | Program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, | ICIS® View is a software application used for reference viewing of medical images and associated reports and, as such, fulfills a key role in Agfa HealthCare's Imaging Clinical | | | Imaging solution. Enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multidisciplinary viewer. Viewer allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements. When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application. | and medical images for diagnosis from different modalities including CR, DR, CT, MR, NM, ECG, and US. Provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. Not intended to replace full | Information System (ICIS). ICIS® View enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images and data from multiple departments and organizations within one multi- disciplinary viewer. Users may access the product directly via a web-browser, select mobile devices, healthcare portal or within the Electronic Medical Record (EMR). ICIS® View allows users to perform basic image manipulations and | | Enterprise Imaging XERO Viewer NEW DEVICE | Carestream Vue Motion (K151774) PRIMARY PREDICATE | Agfa HealthCare's ICIS View (K143397) | | | images and digitized film images should not be used for primary image interpretation. Uncompressed or non- lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA cleared for their intended use. Can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. Full Fidelity Mobile is not intended for the display of mammography images for diagnosis. | and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography. | window/level, rotation, zoom., and markups). ICIS® View can optionally be configured for Full Fidelity mode, which is intended for diagnostic use, review and analysis of CR, DX, CT, MR, US images and medical reports. ICIS® View Full Fidelity is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. ICIS® View full fidelity is not intended for the display of digital mammography images for diagnosis. | | {7}------------------------------------------------ ### Table 1: Device Comparison Table #### PERFORMANCE DATA VI. Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. No clinical trials were performed in the development of the device. There are no applicable FDA mandated performance standards for this device. However, Agfa's in-house standard operating procedures were used for the development of the software; these procedures conform to the following standards: - ISO 13485:2003 Medical Devices Quality Management Systems ● - ISO 14971:2012 Application of Risk Management to Medical Devices ● - ISO 27001:2013 Information Security Management ● - ISO 62366:2007 Medical Devices Application of usability engineering to medical ● devices - IEC 62304:2006 Medical Device Software - Software life cycle processes - ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine ● (DICOM) Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols as used for Medical Image Management Devices as part of verification and validation under design controls (according to 21 CFR 820.30). {8}------------------------------------------------ No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld. XERO Viewer vs. Agfa Enterprise Imaging Desktops (K142316) - Requirements & Performance of Xtend (full fidelity) diagnostic desktop viewing were evaluated (note Xtend Full Fidelity is not supported on mobile devices): To determine substantial equivalence, diagnostic image quality was evaluated by qualified medical professionals comparing images across 2 platforms: - . Enterprise Imaging 8.0.0 Diagnostic Desktop (K142316) - using an FDA cleared diagnostic monitor - XERO Viewer Xtend full fidelity using an FDA cleared diagnostic monitor ● A sample set of an average of 5 or 6 imaging studies per modality were evaluated. Qualified radiologists were asked to provide an overall score when comparing the diagnostic image quality in XERO Viewer to the Enterprise Imaging Diagnostic Desktop. The executed validation plan for image quality was performed on calibrated diagnostic display devices. To evaluate ECG viewing users were asked to display ECG's in DICOM and PDF formats, change layouts, adjust waveforms and use the tools provided (zoom, measurements). Validation and non-clinical (bench) testing was performed on an iPad mobile device to ensure that the views and functionality performed consistently between desktop and a mobile platform. Performance data including image quality evaluations by qualified radiologists are adequate to ensure equivalence to the predicate. ## Summarv Based on the performance data as documented in the above testing, XERO Viewer is found to have a safety and effectiveness profile that is similar to the predicate device. #### VII. CONCLUSIONS The device has indications for use that are consistent with those of the legally marketed predicate device. Where technological characteristics differ lab tests concluded that the device is substantially equivalent to the predicate in that it does not alter the intended therapeutic/diagnostic effect. This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.