Who is the manufacturer of Centricity Universal Viewer?

GE Healthcare filed the 510(k) submission for Centricity Universal Viewer (K182419).

What is the FDA product code for Centricity Universal Viewer?

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

What is the regulatory pathway for Centricity Universal Viewer?

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

Who can help prepare an FDA 510(k) submission like Centricity Universal Viewer?

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.

Centricity Universal Viewer

Q: What are the predicate devices for Centricity Universal Viewer?

Centricity Universal Viewer (K150420).

K182419 · GE Healthcare · LLZ · Dec 14, 2018 · Radiology

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	Software as a Medical Device

Intended 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

Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy (K063628)
Tomtec-Arena (K132544)

Related Devices

K150420 — Centricity Universal Viewer · GE Healthcare · May 26, 2015
K110875 — CENTRICITY PACS · GE Healthcare · May 5, 2011
K123174 — CENTRICITY PACS-IW WITH UNIVERSAL VIEWER · GE Healthcare · Nov 16, 2012
K082706 — INFINITT CARDIOLOGY PACS · Infinitt Co., Ltd. · Nov 6, 2008
K023557 — CENTRICITY PACS PLUS · GE Medical Systems · Nov 7, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image 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, Radiological | | Regulatory Class: | II | | Product Code: | LLZ | {4}------------------------------------------------ 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. [1] Tomtec-Arena™ K132544 has been FDA cleared and CE Marked. {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 Centricity Universal Viewer (K150420) | Subject Device Centricity Universal Viewer with Cath Tools | Discussion of Differences | |----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use / 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. | Identical to predicate device | No change | | Contraindication | Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. | Identical to predicate device | No change | | Feature | Predicate Device Centricity Universal Viewer (K150420) | Subject Device Centricity Universal Viewer with Cath Tools | Discussion of Differences | | | Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. | | | | Cath Analysis Tools | Not supported | Supported in the subject device. The following tools are available to help perform an analysis of images received as a result of a catheterization procedure: 1. Stenosis Analysis 2. Left ventricular analysis 3. Catheter calibration • Point to Point Calibration • Calibration extension 4. Distance measurement | Equivalent. Cath Tools modifications do not change the Intended Use. The Cath Tools functionality added is identical to the Cath Tools in GE Healthcare's, Centricity Radiology RA600, Cardiology CA1000 cleared under K063628. Test results for these modifications do not raise different issues of safety or effectiveness. There are no new potential hazards and no changes to existing potential hazards, and no change in the final risk ratings for the device. | | Workflow | | | | | Interactive search for studies | Search by: 1. Patient name 2. ID 3. Accession Number 4. Study date 5. Study description 6. Modality 7. Study status 8. Referring Physician 9. Date of Birth 10. Referring Service | Same as predicate, except: - Retrieval of off- line study - Access to confidential patient studies based on privileges - Increase number of studies the | Equivalent. Adding the modifications under interactive search for studies does not impact the device safety and effectiveness. | | Feature | Predicate Device Centricity Universal Viewer (K150420) | Subject Device Centricity Universal Viewer with Cath Tools | Discussion of Differences | | | 11. Priority 12. Online status (CPACS only) 13. 0 image studies (CPACS only) 14. Performing physician 15. Location (Enterprise Archive (EA) only for Cardiology) | worklist can display and remove 30 study limit on custom worklists - Support for Technologist study verification workflow and teaching folder - Create, access, save and display key images | | | Search from DICOM server | Search for studies located on the external DICOM compliant server. Supported only on IW backend | Same as predicate, except: - search and retrieve prior exams from external DICOM server - save and display DICOM grayscale presentation state object to work with any type of under- lying hanging protocol | Equivalent. Adding the modifications under the search from DICOM server does not impact the device safety and effectiveness. | | Image Display | | | | | Ability to display information | Ability to display the following: 1. Image 2. Report 3. Patient information 4. Exam information 5. DICOM Header information 6. GSPS 7. RPPS 8. FCE 9. Key Image Notes 10. Exam Notes | Same as predicate, except: - native support of diagnostic interpretation for 2D and DBT mammo images - user, group and system level step protocols - support DICOM metadata in overlay / | Equivalent. These modifications do not change the Intended Use. The device continues to support the display, storage, analysis and processing of various medical images using a similar technology. Test results for these modifications do not raise different issues | | Feature | Predicate Device Centricity Universal Viewer (K150420) | Subject Device Centricity Universal Viewer with Cath Tools | Discussion of Differences | | | 11. Modality and VOI LUT 12. Structured Reports | annotation editor - support synchronized ECG curve, ECG scroll and ECG curve height selector - support Dorsal view (Reverse ACR IHE) for mammography | of safety or effectiveness. There are no new potential hazards and no changes to existing potential hazards, and no change in the final risk ratings for the device. | | Image Annotations and measurements | 1. Line 2. Angle 3. SUV 4. OB Measurements 5. Digital Subtraction Angiography (DSA) 6. Triangulation 7. MIP/MPR 8. Spine Labeling 9. Using "imager pixel spacing" - DICOM field to enable measurements across all CR/DX/US exams. 10. Cardio Thoracic Ratio (CTR) 11. Image Annotations | Same as predicate, except: - Automatically mark images as key when image is annotated - Use "imager pixel spacing" DICOM field to enable measurements across CR/DX/US exams | Equivalent. Adding the modifications for image annotations and measurements does not impact the device safety and effectiveness. These enhancements provide information already available to be used in the same way as the predicate, for the same purpose and by the same users. | | Customized Hanging Protocols | Smart Reading Protocols -Regular Hanging protocols to launch multiple MIP/MPRs | Same as predicate, except: - multi-modality and multi-vendor hanging protocol - dedicated toolbar for mammography features - smart reading protocols learn user's preferences for MRI multiphasic studies | Equivalent. Adding the modifications for customized hanging protocols does not impact the device safety and effectiveness. These enhancements provide information to be used in the same way as the predicate, for the same purpose and by the same users. | | Maximum Intensity | Maximum Intensity Projection (MIP) MIP with | Same as predicate, except: | Equivalent. These modifications do not | | Feature | Predicate Device Centricity Universal Viewer (K150420) | Subject Device Centricity Universal Viewer with Cath Tools | Discussion of Differences | | Projection (MIP) MIP with interactive window-level clipping volume of interest, zoom, pan, and rotate | interactive window-level clipping volume of interest, zoom, pan, and rotate | - Recalculate standard update value on the fly for PET/CT images - Multi-planar reconstruction support multiple oblique reconstruction - Support for non- square pixel image calibration | change the Intended Use. The device continues to support the display, storage, analysis and processing of various medical images using a similar technology. Test results for these modifications do not raise different issues of safety or effectiveness. There are no new potential hazards and no changes to existing potential hazards, and no change in the final risk ratings for the device. | | Printing | | | | | Key Images/Print Pages | Created Print Pages from selected Key Images, one-click placement; customized templates; one click-full screen snapshot | Identical to predicate device | No change | | Print to Film / Paper | Print collage of images to printer | Identical to predicate device | No change | | Connectivity, Interfaces & Interoperability | | | | | Integration | Integration COM service | Identical to predicate device | No change | | Interfaces | Generic interface to integrate outbound with third party applications and internal GEHC applications that meet the interface requirements. | Same as predicate, except: - Update to API connectivity to launch newer versions of 3rd party software | Equivalent. Adding modifications for the interfaces does not impact the device safety and effectiveness. There are no new potential hazards. | | Feature | Predicate Device Centricity Universal Viewer (K150420) | Subject Device Centricity Universal Viewer with Cath Tools | Discussion of Differences | | | | applications such as GE Healthcare's EchoPAC and Advantage Workstation applications | hazards and no changes to existing potential hazards, and no change in the final risk ratings for the device. | | External system launch | The viewer can be launched via a 3rd party application using the following methods: 1. url launch 2. IVAPI 3. Inbound API | Same as predicate, except: - Updates in interfaces with 3rd party software applications - URL launch using SUID when study associated with multiple orders | Equivalent. Adding modifications under external system launch does not impact the device safety and effectiveness. These enhancements provide information to be used in the same way as the predicate, for the same purpose and by the same users. | | Administrative | | | | | Interactive query | In console, supporting wildcards | Identical to predicate device | No change | | Setup | Wizard and silent | Identical to predicate device | No change | | On-line help | Yes | Identical to predicate device | No change | | User Interface and User Manual Languages | 1. English, 2. German, 3. Japanese, 4. French, 5. Simplified Chinese 6. Italian, 7. Polish, 8. Spanish 9. Turkish, 10. Brazilian Portuguese, 11. Dutch, 12. Swedish, 13. Russian 14. Korean, 15. Finnish, 16. Danish, 17. Norwegian, 18. Traditional Chinese 19. Portuguese, 20. Greek, 21. Hungarian | Identical to 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…