Who is the manufacturer of Merge PACS?

Merge Healthcare Incorporated filed the 510(k) submission for Merge PACS (K192455).

What is the FDA product code for Merge PACS?

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

What is the regulatory pathway for Merge PACS?

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

Who can help prepare an FDA 510(k) submission like Merge PACS?

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.

Merge PACS

K192455 · Merge Healthcare Incorporated · LLZ · Oct 17, 2019 · Radiology

Device Facts

Record ID	K192455
Device Name	Merge PACS
Applicant	Merge Healthcare Incorporated
Product Code	LLZ · Radiology
Decision Date	Oct 17, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals. Data can be received directly from acquisition modalities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae). The Real Time Worklist (RTWL) displays the real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, configurable components. The Patient Dashboard provides a composite view of patient data, both imaging and nonimaging. Multi-tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities. Order and report information generated by the HIS/RIS and report creation systems are received and displayed via the transmission of HL7 messaging. Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication. Merge PACS displays full fidelity DICOM images for use in the diagnostic interpretation of mammography using MG or BTO images. Thick slab MIP presentation can be applied to BTO images. Lossy compressed images and digitized screen film images must not be used for primary diagnosis of mammography studies, and only display monitors that have regulatory clearance for mammography interpretation should be used for the interpretation of mammography studies.

Device Story

Merge PACS is a software-based diagnostic workstation for medical imaging. It ingests DICOM-compliant data from modalities (CT, MR, PET, etc.), CAD systems, and other image processing systems; non-DICOM data (e.g., photos) is converted to DICOM. The device provides tools for image manipulation, including MPR, MIP, 3D fusion/registration, CVR, and measurements (linear, area, SUV). It manages radiology workflows via a Real-Time Worklist (RTWL) and integrates with HIS/RIS/EMR systems via HL7. Used in hospitals or remotely by radiologists and clinicians, it facilitates diagnostic interpretation and reporting. The device supports lossless/lossy compression and provides a patient dashboard for composite data viewing. Benefits include efficient workflow management, multi-modality image analysis, and improved access to patient imaging history. The current version adds Region Analysis Area and Volume tools for 3D SUV calculations.

Clinical Evidence

No clinical studies were required. Substantial equivalence is supported by bench testing, including risk analysis, requirements review, design reviews, unit-level testing, integration testing, and performance testing. The device complies with NEMA PS 3.1-3.20 (2016) DICOM standards.

Technological Characteristics

Software-based PACS running on off-the-shelf hardware (Windows 10/Server 2016). Features include DICOM-compliant image processing, display, and storage. Connectivity via DICOM (imaging) and HL7 (HIS/RIS/EMR). Supports 2D/3D image manipulation (MPR, MIP, CVR, SUV calculation). Software level of concern: Moderate.

Indications for Use

Indicated for radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, SC) medical image processing, display, diagnostic reading, reporting, communication, printing, and storage.

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

Merge PACS (K173475)

Reference Devices

Xelis Fusion (K111613)

Related Devices

K173475 — Merge PACS · Merge Healthcare Incorporated · Dec 8, 2017
K190232 — Synapse PACS · Fujifilm Corporation · Mar 26, 2019
K160371 — NovaPACS · Novarad Corporation · Oct 14, 2016
K192508 — Medsynapse Ris Pacs & Medsynapse VNA · Medsynaptic Private, Ltd. · Nov 22, 2019
K022970 — AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0 · Amicas, Inc. · Nov 22, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ October 17, 2019 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Merge Healthcare Incorporated % Ms. Amy Tannenbaum Regulatory Affairs Specialist 900 Walnut Ridge Drive HARTLAND WA 53209 Re: K192455 Trade/Device Name: Merge PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 16, 2019 Received: September 17, 2019 Dear Ms. Tannenbaum: 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/cfpmp/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 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 {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Section 4 Indications for Use Statement (Form 3881) Image /page/2/Picture/5 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or globe with radiating lines on the left. To the right of the image is the text "Watson Health" in a bold, sans-serif font. The letters are black, and there is a trademark symbol after the word "Health". {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192455 Device Name Merge PACS #### Indications for Use (Describe) Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, and other qualified medical professionals. Data can be received directly from acquisities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae). The Real Time Worklist (RTWL) displays the real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, configurable components. The Patient Dashboard provides a composite view of patient data, both imaging. Multi-tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities. Order and report information generated by the HIS/RIS and report creation systems are received and displayed via the transmission of HL7 messaging. Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication. Merge PACS displays full fidelity DICOM images for use in the diagnostic interpretation of mammography using MG or BTO images. Thick slab MIP presentation can be applied to BTO images. Lossy compressed images and digitized screen film images must not be used for primary diagnosis of mammography studies, and only display monitors that have regulatory clearance for mammography interpretation should be used for the interpretation of mammography studies. Type of Use (*Select one or both, as applicable*) | <svg height="12" width="12"> <rect height="12" style="fill:none;stroke-width:2;stroke:black" width="12"></rect> <path d="M2,2 L10,10 M10,2 L2,10" stroke="black" stroke-width="2"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | <svg height="12" width="12"> <rect height="12" style="fill:none;stroke-width:2;stroke:black" width="12"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ 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 0MB number." {5}------------------------------------------------ ## 510(k) Summary - Merge PACS K192455 In accordance with 21 CFR 807.92 the following summary of information is provided: | Submitter Information | | |------------------------------|---------------------------------------------------------------------------------------------------------| | Submitter: | Merge Healthcare Incorporated 900 Walnut Ridge Drive Hartland, Wisconsin 53209 USA | | 510(k) Number: | K192455 | | Date Prepared: | September 6, 2019 | | Contact Person: | Amy Tannenbaum Regulatory Affairs Specialist Phone: 617-528-3087 Email: amy.tannenbaum@ibm.com | | Secondary Contact: | Tracey Fox Global Regulatory Affairs, Manager Phone: 1-262-369-3156 Email: tracey.fox@ibm.com | | Identification of the Device | | | Trade Name: | Merge PACS | | Common Name: | Picture Archiving and Communication System (PACS) | | Classification Name: | Radiological Image Processing System 21 CFR 892 2050 | Product Code: Device Class: #### Predicate Device(s) Primary Predicate: Merge PACS (K173475) Reference Predicate: Xelis Fusion (K111613) LLZ Class II Image /page/5/Picture/6 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or lightbulb on the left, followed by the text "Watson Health" in a bold, sans-serif font. There is a green bar at the top of the image. {6}------------------------------------------------ # Device Description Merge PACS, a software medical device, is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians' worklists and retrieving and managing studies for reading, reporting, communication, and storage. Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) via DICOM protocol, for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.) via HL7. Merge PACS can be accessed from within the hospital or enterprise, or from remote locations via web-based access. Images viewed on mobile devices should not be used for diagnostic purposes. The focus of this premarket notification is on the addition of the Region Analysis Area and Region Analysis Volume tools, which allows for additional clinical analysis of images, including volumetric Standard Uptake Value (SUV) calculation. There has been a minor change in the indications for use statement from the previous Merge PACS device, with the removal of the optional Reach component which is no longer offered. Additional non-significant changes since the previous submission will be discussed. ## Intended Use/ Indications for Use Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals. Data can be received directly from acquisition modalities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae). Image /page/6/Picture/9 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a globe with lines emanating from it, followed by the text "Watson Health" in a bold, sans-serif font. The letters are black, and there is a trademark symbol after the word "Health". {7}------------------------------------------------ The Real Time Worklist (RTWL) displays the real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, configurable components. The Patient Dashboard provides a composite view of patient data, both imaging and nonimaging. Multi-tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities. Order and report information generated by the HIS/RIS and report creation systems are received and displayed via the transmission of HL7 messaging. Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication. Merge PACS displays full fidelity DICOM images for use in the diagnostic interpretation of mammography using MG or BTO images. Thick slab MIP presentation can be applied to BTO images. Lossy compressed images and digitized screen film images must not be used for primary diagnosis of mammography studies, and only display monitors that have regulatory clearance for mammography interpretation should be used for the interpretation of mammography studies. # Technological Characteristics Merge PACS and its predicate device(s) have the same fundamental scientific technology. The primary predicate is the previous Merge PACS (K173475) for which the subject device is a modification of, with reference predicate Xelis Fusion (K111613). The subject device has the same basic intended use as the predicates and near identical indications for use as Merge PACS (K173475). The devices have essentially the same basic image processing, display, storage, and communication features, based on the same or similar technology. Availability and bundling and naming of additional features and toolsets may vary between the devices, but the technology behind each feature is essentially the same regardless of how it is catered to a specific user. It is our opinion that the subject Merge PACS device is substantially equivalent to the previous Merge PACS (K173475) as it is an earlier version of the device that contains the same technology and functionality. The subject device is also substantially equivalent to the reference predicate, Xelis Fusion (K111613), sharing essentially the same basic image processing, display. storage and communication features as well as the new capability of volumetric SUV measurements. # Determination of Substantial Equivalence The modifications to Merge PACS include updates to the software and labeling from the previous Merge PACS K173475. A summary of the key changes in the subject Merge PACS Image /page/7/Picture/11 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or globe with rays emanating from it, followed by the text "Watson Health" in bold, black font. The letters are sans-serif and the word "Health" is followed by the trademark symbol. {8}------------------------------------------------ device are summarized below with comparison to its predicates. Additional non-significant changes and bug fixes have been made to improve workflow and security, and do not have an impact on clinical functionality of the device. Image /page/8/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized sun-like graphic on the left, followed by the words "Watson Health" in a bold, sans-serif font. A small trademark symbol appears to the right of the word "Health". {9}------------------------------------------------ Table 1: Comparison to predicates | Category | Feature/ Information | Subject Merge PACS (K192455) | Primary Predicate: Merge PACS (K173475) | Reference Predicate: Xelis Fusion (K111613) | Clinically Significant Change? | |---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General | Common Name of Device/ Classification Product code | Picture Archiving and Communications System (PACS) 21 CFR 892.2050 LLZ- Radiological Image Processing System | Picture Archiving and Communications System (PACS) 21 CFR 892.2050 LLZ- Radiological Image Processing System | Picture Archiving and Communications System (PACS) 21 CFR 892.2050 LLZ- Radiological Image Processing System | No changes | | | Operating System | Windows 10 | Windows 7/8.1/10 | Unknown | Not a clinically significant difference - support for latest Windows OS. | | | Browser Support | Internet Explorer 11, Edge, Chrome | Internet Explorer 7, 8, 9, 10, 11 | Unknown | Not a clinically significant difference - support for new browser only | | | Server OS Support | Windows 2016 64-bit, Windows 2012 R2 | Windows 2012 R2 | Windows 32 and 64- bit | Not a clinically significant difference - support for latest server OS | | | Indication for Use Statement | Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DB/DX, NM, XA | Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DB/DX, NM, XA, RF | The Xelis Fusion is a software device that receives digital images and data from various sources (e.g. CT | There is only a minor change in the indications for use statement from the previous Merge PACS device, with the removal of the optional Reach | | Category | Feature/ Information | Subject Merge PACS (K192455) | Primary Predicate: Merge PACS (K173475) | Reference Predicate: Xelis Fusion (K111613) | Clinically Significant Change? | | | | RF, secondary capture (SC), and other DICOM- compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals. | secondary capture (SC), and other DICOM- compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals. | scanners, MR ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other image sources). Diagnosis or computer aided diagnosis is not performed by the software but by Radiologists. | component which is no longer offered. Similar indications to reference predicate. There is no clinically significant difference as Reach was not used by radiologists for diagnosis. | | | | Data can be received directly from acquisition modalities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM- compliant, such as photos, can be converted | Data can be received directly from acquisition modalities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM- compliant, such as photos, can be converted to | Images (including mammographic) and data can be stored, communicated, processed and displayed within the system and or across computer networks at | | | Category | Feature/ Information | Subject Merge PACS (K192455) | Primary Predicate: Merge PACS (K173475) | Reference Predicate: Xelis Fusion (K111613) | Clinically Significant Change? | | | | to DICOM format by Merge PACS. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae). The Real Time Worklist (RTWL) displays the real- time status of radiology activity and provides customizable workflow management capabilities. | DICOM format by Merge PACS. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae). The Real Time Worklist (RTWL) displays the real- time status of radiology activity and provides customizable workflow management capabilities. Communication of critical | distributed locations. In addition, Xelis Fusion can be integrated with an institution's HIS or RIS for an integrated and electronic patient record. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using and FDA approved monitor that offers at least 5 Mega- pixel resolution and meets other technical specifications | | | Category | Feature/ Information | Subject Merge PACS (K192455) | Primary Predicate: Merge PACS (K173475) | Reference Predicate: Xelis Fusion (K111613) | Clinically Significant Change? | | | | Communication of critical results is facilitated and documented through optional, configurable components. The Patient Dashboard provides a composite view of patient data, both imaging and non- imaging. Multi-tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities. Order and report information generated by the HIS/RIS and report creation systems are received and displayed via the transmission of HL7 messaging. | results is facilitated and documented through optional, configurable components. The Patient Dashboard provides a composite view of patient data, both imaging and non-imaging. The optional Reach component provides clinicians with secure, proactive communication and access to clinical reports and images. Multi- tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities. Order and report information generated by the HIS/RIS and report creation systems are received and displayed via | reviewed and accepted by FDA. | | | Category | Feature/ Information | Subject Merge PACS (K192455) | Primary Predicate: Merge PACS (K173475) | Reference Predicate: Xelis Fusion (K111613) | Clinically Significant Change? | | | | Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication. Merge PACS displays full fidelity DICOM images for use in the diagnostic interpretation of mammography using MG or BTO images. Thick slab MIP presentation can be applied to BTO images. Lossy compressed images and digitized screen film images must not be used for primary diagnosis of mammography studies, and only display monitors that have regulatory clearance for mammography interpretation should be used for the | the transmission of HL7 messaging. Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication. Merge PACS displays full fidelity DICOM images for use in the diagnostic interpretation of mammography using MG or BTO images. Thick slab MIP presentation can be applied to BTO images. Lossy compressed images and digitized screen film images must not be used for primary diagnosis of mammography studies, and only display monitors that have regulatory clearance for mammography | | | | Category | Feature/ Information | Subject Merge PACS (K192455) | Primary Predicate: Merge PACS (K173475) | Reference Predicate: Xelis Fusion (K111613) | Clinically Significant Change? | | | | interpretation of mammography studies. | interpretation should be used for the interpretation of mammography studies. | | | | Significant change(s) introduced in subject device Merge PACS: | | | | | | | Measurement | SUV Calculation (PET) | Probe Tool, ROI Tool Regional Area Analysis and Regional Volume Analysis 2D and 3D SUV calculations | Probe Tool and ROI Tool 2D SUV calculations only | Supports 3D region of interest (ROI) SUV analysis | Addition of Region Area and Volume Analysis tools allows for additional clinical analysis of PET images for patient treatment, including 3D SUV calculations. The reference predicate device shares this new feature with the subject Merge PACS. Applicable verification and validation testing has been performed to justify the safety and efficacy of this difference from the primary predicate. | | Category | Feature/ Information | Subject Merge PACS (K192455) | Primary Predicate: Merge PACS (K173475) | Reference Predicate: Xelis Fusion (K111613) | Clinically Significant Change? | | Non-significant changes(s) introduced in subject device Merge PACS: | | | | | | | Viewer | Terarecon Integration | Yes - Terarecon embedded in Merge PACS, opens in same window | Yes - Terarecon opens in separate window | Unknown | Not a clinically significant difference. End functionality owned by Terarecon. Smoother integration with Merge PACS for user convenience, but no clinical impact to the patient. | | | Automatic Registration for series that do not share a common frame of reference | Yes | No - Automatic linking of series with same frame of reference UID and manually linking of series that do not share a common frame of reference only | Yes | Not a clinically significant difference for Merge PACS. Automatic registration is through the functionality of Blackford to deliver DICOM objects to Merge PACS for automatic registration of series that do not share a common frame of reference. No impact to safety or effectiveness. | | | Patient Synopsis information within Patient Record | Yes | No | Similar functionality - can Integrate with patient record | Not a clinically significant different, Watson Imaging Patient Synopsis provides a new option for clinicians to view patient information. | | Category | Feature/ Information | Subject Merge PACS (K192455)…