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.

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.

AI/ML Overview

The provided document describes the GE Healthcare Centricity Universal Viewer (K182419), a medical image display and interpretation software. The submission aims to establish substantial equivalence to a predicate device (K150420) by detailing modifications and demonstrating that these changes do not alter the intended use or raise new safety/effectiveness concerns.

Here's an analysis of the acceptance criteria and study information, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail format. Instead, it focuses on demonstrating "equivalence" to the predicate device and that modifications do not raise new safety or effectiveness issues. The performance is described through verification and validation activities.

Feature Area	Predicate Device (K150420) Performance	Subject Device (K182419) Performance	Discussion of Differences / Equivalence
Intended Use / Indications For Use	Displays medical images/data, assists in viewing, analysis, diagnostic interpretation, sharing. Mammography interpretation requires compliant monitor.	Identical to predicate device.	No change.
Contraindication	Lossy compressed mammographic images and digitized film screen images not for primary interpretation.	Identical to predicate device.	No change.
Cath Analysis Tools	Not supported.	Supported: Stenosis Analysis, Left ventricular analysis, Catheter calibration (Point to Point, extension), Distance measurement.	Equivalent. Functionality identical to K063628. No new potential hazards or changes in risk ratings.
Workflow: Interactive Search for Studies	Search by: Patient name, ID, Accession Number, Study date, Study description, Modality, Study status, Referring Physician, Date of Birth, Referring Service, Priority, Online status (CPACS only), 0 image studies (CPACS only), Performing physician, Location (EA only for Cardiology).	Same as predicate, except: retrieval of off-line study, access to confidential patient studies based on privileges, increased number of studies the worklist can display (removed 30 study limit), support for Technologist study verification workflow and teaching folder, create/access/save/display key images.	Equivalent. Modifications do not impact device safety and effectiveness.
Workflow: Search from DICOM Server	Search for studies on external DICOM server (IW backend only).	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 underlying hanging protocol.	Equivalent. Modifications do not impact device safety and effectiveness.
Image Display: Ability to Display Information	Ability to display: Image, Report, Patient information, Exam information, DICOM Header, GSPS, RPPS, FCE, Key Image Notes, Exam Notes, Modality and VOI LUT, Structured Reports.	Same as predicate, except: native support of diagnostic interpretation for 2D and DBT mammo images, user/group/system level step protocols, support DICOM metadata in overlay / annotation editor, support synchronized ECG curve/scroll/height selector, support Dorsal view (Reverse ACR IHE) for mammography.	Equivalent. Modifications do not change intended use, device continues to support display/storage/analysis/processing of medical images using similar technology. No new potential hazards or changes in risk ratings.
Image Annotations and Measurements	Line, Angle, SUV, OB Measurements, Digital Subtraction Angiography (DSA), Triangulation, MIP/MPR, Spine Labeling, "imager pixel spacing" for CR/DX/US measurements, Cardio Thoracic Ratio (CTR), Image Annotations.	Same as predicate, except: automatically mark images as key when annotated, use "imager pixel spacing" DICOM field for CR/DX/US measurements.	Equivalent. Modifications do not impact device safety and effectiveness. Enhancements provide information already available to be used in the same way.
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. Modifications do not impact device safety and effectiveness. Enhancements provide information to be used in the same way.
Maximum Intensity Projection (MIP)	MIP with interactive window-level clipping volume of interest, zoom, pan, and rotate.	Same as predicate, except: 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.	Equivalent. Modifications do not change intended use. No new potential hazards or changes in risk ratings.
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.
Printing: 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.
Connectivity, Interfaces & Interoperability: Interfaces	Generic interface to integrate outbound with third-party and internal GEHC applications.	Same as predicate, except: update to API connectivity to launch newer versions of 3rd party software applications (e.g., GE Healthcare's EchoPAC and Advantage Workstation).	Equivalent. Modifications do not impact device safety and effectiveness. No new potential hazards.
Connectivity, Interfaces & Interoperability: External System Launch	Viewer launched via 3rd party application using: url launch, IVAPI, 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. Modifications do not impact device safety and effectiveness. Enhancements provide information to be used in the same way.
Administrative: Interactive Query	In console, supporting wildcards.	Identical to predicate device.	No change.
Administrative: Setup	Wizard and silent.	Identical to predicate device.	No change.
Administrative: On-line Help	Yes.	Identical to predicate device.	No change.
Administrative: User Interface and User Manual Languages	21 languages listed (e.g., English, German, Japanese).	Identical to predicate device.	No change.
Administrative: Administrative Rights Assignment	Per user/group.	Identical to predicate device.	No change.
Administrative: Automatic Notification Messages	By email, HL7.	Same as predicate, except: auto refresh and notification when new images arrive, merge two studies into one, audit log to track export of images.	Equivalent. Modifications do not impact device safety and effectiveness. Enhancements provide information to be used in the same way.
Administrative: System Logging	Combined system log.	Identical to predicate device.	No change.
Compression	Wavelet (JPEG2000 lossless/lossy), Non-wavelet (JPEG lossless/lossy), JPEG2000 lossless for uncompressed images.	Identical to predicate device.	No change.
Minimal System Requirements: Offering	Turnkey solution (software + hardware), Software only solution.	Identical to predicate device.	No change.
Minimal System Requirements: ESXi	VMware vSphere ESXi.	Identical to predicate device.	No change.
Workstation Features: Operating System for Diagnostic Workstation	Microsoft™ Windows 7 - 64 bit, Microsoft™ Windows 8.1 - 64 bit.	Same as predicate, except: adding support for Windows 10 operating system (32 or 64 bit) with Internet Explorer 11.	Equivalent. Adding support for Windows 10 does not impact device safety and effectiveness.
Workstation Features: Minimum Hardware Requirement for Diagnostic Workstation	2 Quad-core processor of 2.0 GHz or more, 8GB RAM minimum, 146GB drive in Raid 0, DVD-RW, One 1GB NIC, 4 Mbps and faster TCP-IP network.	Identical to predicate device.	No change.
Security: User Authentication using a 3rd Party Authentication Server	Active Directory.	Same as predicate, except: provides common authentication, security hardening and cybersecurity improvements.	Equivalent. Modifications do not impact device safety and effectiveness.
Enterprise Imaging: DICOM Protocol	Supports DICOM SOP classes, Receive images - DICOM storage SCP, Support DICOM 3.0 input, presentation states.	Same as predicate, except: support additional color (YBR) interpretations with US images, support saving image calibration information in Presentation State.	Equivalent. Modifications do not impact device safety and effectiveness. Enhancements provide information to be used in the same way.
Enterprise Imaging: (XED) Cross Enterprise Display	View patient information across multiple enterprise sites based on matching patient ID numbers.	Same as predicate, except: New API to access patient history in FHIR format and from different sources, enhance ability to group studies anatomically, matching patient studies from remote sites with the same patient.	Equivalent. Modifications do not impact device safety and effectiveness. Enhancements allow patient history to be used in the same way.
User Environment	Designed to be utilized inside and outside of radiology and cardiology.	Identical to predicate device.	No change.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It mentions "verification and validation testing" and "system verification testing of system level requirements," but no details on data used in those tests. The only indirect mention of data source for features is that "All images located on the Centricity Universal Viewer have been received from DICOM compliant modalities and/or image acquisition systems."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide any information about the number of experts or their qualifications used to establish ground truth for a test set. This type of information is typically relevant for studies evaluating diagnostic accuracy, which is not the primary focus of this submission (which emphasizes modifications and equivalence of a viewing device).

4. Adjudication Method for the Test Set

No information about an adjudication method is provided, as no specific diagnostic performance study requiring adjudicated ground truth is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size with/without AI Assistance

No MRMC comparative effectiveness study is mentioned. This submission is for a medical image viewing and processing software, not an AI diagnostic algorithm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No standalone algorithm performance study is mentioned. The device is described as "intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images," indicating human-in-the-loop use.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for any testing. Performance is primarily framed around verification against design requirements and validation against user needs and intended uses, implying functional and technical testing rather than diagnostic ground truth.

8. The Sample Size for the Training Set

No information about a training set size is provided. The device is described primarily as viewing and processing software, not a machine learning model that would require a distinct training set. The "Cath Tools" functionality is stated to be identical to a previously cleared product (K063628), suggesting its underlying algorithms may have been established earlier.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, there is no information on how its ground truth would have been established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in blue.

December 14, 2018

GE Healthcare Renee Webb Senior Regulatory Affairs Manager 500 West Monroe Street CHICAGO, IL 60661

Re: K182419

Trade/Device Name: Centricity Universal Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 20, 2018 Received: September 26, 2018

Dear Renee Webb:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website

(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hole 2. Nils

for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182419

Device Name Centricity Universal Viewer

Indications for Use (Describe)

Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

Contraindications:

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)

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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

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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 not intended for the diagnosis of digital pathology images.

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.

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V. INDICATIONS FOR USE

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:

The Intended Use / Indications for Use statement is identical to the Predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject Centricity Universal Viewer device continues to support the display, storage, analysis and processing of various medical images using similar technology.

The basis for this premarket notification is a modification of the legally marketed Centricity Universal Viewer device to incorporate additional features. These modifications do not change the Intended Use. These changes include enhancements and other updates to support customer feedback and to enhance usability of the software application. These modifications improve on the subject device's ability to assist healthcare professionals in the display, storage, processing, and diagnostic analysis of various medical images similarly to the predicate Centricity Universal Viewer.

The Centricity Universal Viewer architecture and SOUP software and software core algorithms have not changed. The Cath Tools algorithm has not changed. Cath Tools adds functionality that already existed in K063628 onto the Centricity Universal Viewer software technology stack.

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The following table contains a comparison of the key changes since the last 510k clearance K150420:

Feature	Predicate DeviceCentricity UniversalViewer(K150420)	Subject DeviceCentricity UniversalViewerwith Cath Tools	Discussion ofDifferences
Intended Use /Indications ForUse	Centricity UniversalViewer is a device thatdisplays medical imagesand data from variousimaging sources, andfrom other healthcareinformation sources.Medical images and datacan be displayed,communicated, stored,and processed.Typical users of thissystem are authorizedhealthcare professionals.Centricity UniversalViewer is intended toassist in the viewing,analysis, diagnosticinterpretation, andsharing of images andother information.Mammography imagesmay only be interpretedusing a monitorcompliant withrequirements of localregulations and mustmeet other technicalspecifications reviewedand accepted by thelocal regulatoryagencies.	Identical topredicate device	No change
Contraindication	Centricity Universal Vieweris contraindicated for theuse of lossy compressedmammographic images.	Identical topredicate device	No change
Feature	Predicate DeviceCentricity UniversalViewer(K150420)	Subject DeviceCentricity UniversalViewerwith Cath Tools	Discussion ofDifferences
	Lossy compressedmammographic imagesand digitized film screenimages must not bereviewed for primary imageinterpretations.
Cath AnalysisTools	Not supported	Supported in thesubject device.The following toolsare available to helpperform an analysisof images receivedas a result of acatheterizationprocedure:1. Stenosis Analysis2. Left ventricularanalysis3. Cathetercalibration• Point to PointCalibration• Calibrationextension4. Distancemeasurement	Equivalent. CathTools modificationsdo not change theIntended Use. TheCath Toolsfunctionality added isidentical to the CathTools in GEHealthcare's,Centricity RadiologyRA600, CardiologyCA1000 clearedunder K063628. Testresults for thesemodifications do notraise different issuesof safety oreffectiveness. Thereare no new potentialhazards and nochanges to existingpotential hazards,and no change in thefinal risk ratings forthe device.
Workflow
Interactivesearch forstudies	Search by:1. Patient name2. ID3. Accession Number4. Study date5. Study description6. Modality7. Study status8. Referring Physician9. Date of Birth10. Referring Service	Same as predicate,except:- Retrieval of off-line study- Access toconfidentialpatient studiesbased onprivileges- Increase numberof studies the	Equivalent. Addingthe modificationsunder interactivesearch for studiesdoes not impact thedevice safety andeffectiveness.
Feature	Predicate DeviceCentricity UniversalViewer(K150420)	Subject DeviceCentricity UniversalViewerwith Cath Tools	Discussion ofDifferences
	11. Priority12. Online status (CPACSonly)13. 0 image studies(CPACS only)14. Performing physician15. Location (EnterpriseArchive (EA) only forCardiology)	worklist candisplay andremove 30 studylimit on customworklists- Support forTechnologiststudy verificationworkflow andteaching folder- Create, access,save and displaykey images
Search fromDICOM server	Search for studieslocated on the externalDICOM compliant server.Supported only on IWbackend	Same as predicate,except:- search andretrieve priorexams fromexternal DICOMserver- save and displayDICOM grayscalepresentationstate object towork with anytype of under-lying hangingprotocol	Equivalent. Addingthe modificationsunder the searchfrom DICOM serverdoes not impact thedevice safety andeffectiveness.
Image Display
Ability to displayinformation	Ability to display thefollowing:1. Image2. Report3. Patient information4. Exam information5. DICOM Headerinformation6. GSPS7. RPPS8. FCE9. Key Image Notes10. Exam Notes	Same as predicate,except:- native support ofdiagnosticinterpretation for2D and DBTmammo images- user, group andsystem level stepprotocols- support DICOMmetadata inoverlay /	Equivalent. Thesemodifications do notchange the IntendedUse. The devicecontinues to supportthe display, storage,analysis andprocessing of variousmedical images usinga similar technology.Test results for thesemodifications do notraise different issues
Feature	Predicate DeviceCentricity UniversalViewer(K150420)	Subject DeviceCentricity UniversalViewerwith Cath Tools	Discussion ofDifferences
	11. Modality and VOI LUT12. Structured Reports	annotation editor- supportsynchronized ECGcurve, ECG scrolland ECG curveheight selector- support Dorsalview (ReverseACR IHE) formammography	of safety oreffectiveness. Thereare no new potentialhazards and nochanges to existingpotential hazards,and no change in thefinal risk ratings forthe device.
ImageAnnotations andmeasurements	1. Line2. Angle3. SUV4. OB Measurements5. Digital SubtractionAngiography (DSA)6. Triangulation7. MIP/MPR8. Spine Labeling9. Using "imager pixelspacing" - DICOM field toenable measurementsacross all CR/DX/USexams.10. Cardio Thoracic Ratio(CTR)11. Image Annotations	Same as predicate,except:- Automaticallymark images askey when image isannotated- Use "imager pixelspacing" DICOMfield to enablemeasurementsacross CR/DX/USexams	Equivalent. Addingthe modifications forimage annotationsand measurementsdoes not impact thedevice safety andeffectiveness. Theseenhancementsprovide informationalready available tobe used in the sameway as the predicate,for the same purposeand by the sameusers.
CustomizedHangingProtocols	Smart Reading Protocols-Regular Hangingprotocols to launchmultiple MIP/MPRs	Same as predicate,except:- multi-modality andmulti-vendorhanging protocol- dedicated toolbarfor mammographyfeatures- smart readingprotocols learnuser's preferencesfor MRImultiphasicstudies	Equivalent. Addingthe modifications forcustomized hangingprotocols does notimpact the devicesafety andeffectiveness. Theseenhancementsprovide informationto be used in thesame way as thepredicate, for thesame purpose and bythe same users.
MaximumIntensity	Maximum IntensityProjection (MIP) MIP with	Same as predicate,except:	Equivalent. Thesemodifications do not
Feature	Predicate DeviceCentricity UniversalViewer(K150420)	Subject DeviceCentricity UniversalViewerwith Cath Tools	Discussion ofDifferences
Projection (MIP)MIP withinteractivewindow-levelclipping volumeof interest,zoom, pan, androtate	interactive window-levelclipping volume ofinterest, zoom, pan, androtate	- Recalculatestandard updatevalue on the fly forPET/CT images- Multi-planarreconstructionsupport multipleobliquereconstruction- Support for non-square pixel imagecalibration	change the IntendedUse. The devicecontinues to supportthe display, storage,analysis andprocessing of variousmedical images usinga similar technology.Test results for thesemodifications do notraise different issuesof safety oreffectiveness. Thereare no new potentialhazards and nochanges to existingpotential hazards,and no change in thefinal risk ratings forthe device.
Printing
KeyImages/PrintPages	Created Print Pages fromselected Key Images,one-click placement;customized templates;one click-full screensnapshot	Identical topredicate device	No change
Print to Film /Paper	Print collage of images toprinter	Identical topredicate device	No change
Connectivity,Interfaces &Interoperability
Integration	Integration COM service	Identical topredicate device	No change
Interfaces	Generic interface tointegrate outbound withthird party applicationsand internal GEHCapplications that meetthe interfacerequirements.	Same as predicate,except:- Update to APIconnectivity tolaunch newerversions of 3rdparty software	Equivalent. Addingmodifications for theinterfaces does notimpact the devicesafety andeffectiveness. Thereare no new potentialhazards.
Feature	Predicate DeviceCentricity UniversalViewer(K150420)	Subject DeviceCentricity UniversalViewerwith Cath Tools	Discussion ofDifferences
		applications suchas GE Healthcare'sEchoPAC andAdvantageWorkstationapplications	hazards and nochanges to existingpotential hazards,and no change in thefinal risk ratings forthe device.
External systemlaunch	The viewer can belaunched via a 3rd partyapplication using thefollowing methods:1. url launch2. IVAPI3. Inbound API	Same as predicate,except:- Updates ininterfaces with 3rdparty softwareapplications- URL launch usingSUID when studyassociated withmultiple orders	Equivalent. Addingmodifications underexternal systemlaunch does notimpact the devicesafety andeffectiveness. Theseenhancementsprovide informationto be used in thesame way as thepredicate, for thesame purpose and bythe same users.
Administrative
Interactivequery	In console, supportingwildcards	Identical topredicate device	No change
Setup	Wizard and silent	Identical topredicate device	No change
On-line help	Yes	Identical topredicate device	No change
User Interfaceand UserManualLanguages	1. English, 2. German,3. Japanese, 4. French,5. Simplified Chinese6. Italian, 7. Polish, 8.Spanish9. Turkish, 10. BrazilianPortuguese, 11. Dutch,12. Swedish, 13. Russian14. Korean, 15. Finnish,16. Danish, 17.Norwegian,18. Traditional Chinese19. Portuguese, 20.Greek,21. Hungarian	Identical topredicate 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
Automatic notification messages	By email. HL7	Same as predicate, except: - auto refresh and notification when new images arrive - merge two studies into one - audit log to track export of images	Equivalent. Adding modifications under automatic notification messages 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.
System logging	Combined system log	Identical to predicate device	No change
Compression	Wavelet compression1. JPEG2000 lossless2. JPEG2000 lossyNon-wavelet compression1. JPEG lossless2. JPEG lossyJPEG2000 lossless for images received uncompressed	Identical to predicate device	No change
Minimal System RequirementsOffering	1. Turnkey solution (GEHC IT provides both the software and hardware required to function as a complete system)2. Software only solution (GEHC IT provides and deploys the Software).	Identical to predicate device	No change
ESXi	VMware vSphere ESXi	Identical to predicate device	No change
Feature	Predicate DeviceCentricity UniversalViewer(K150420)	Subject DeviceCentricity UniversalViewerwith Cath Tools	Discussion ofDifferences
WorkstationFeatures
OperatingSystem forDiagnosticWorkstation	Microsoft™ Windows 7 -64 bitMicrosoft™ Windows 8.1- 64 bit	Same as predicate,except:- adding support forWindows 10operating system32 or 64 bit withInternet Explorer11	Equivalent. Addingsupport for Windows10 operating system32 or 64 bit withInternet Explorer 11does not impact thedevice safety andeffectiveness.
MinimumHardwarerequirement forDiagnosticWorkstation	2 Quad-core processor of2.0GHz or more8GB RAM minimum146GB drive in Raid 0configurationDVD-RW Optical driveOne 1GB NIC10/100/1000 MbEthernetnetwork4 Mbps and faster TCP-IPnetwork	Identical topredicate device	No change
Security
UserAuthenticationusing a 3rdPartyAuthenticationServer	Active Directory	Same as predicate,except:- Provides commonauthentication- securityhardening andcybersecurityimprovements	Equivalent. Addingcommonauthenticationsupport and securityhardening does notimpact the devicesafety andeffectiveness.
EnterpriseImaging
DICOM Protocol	1. Supports DICOM SOPclasses2. Receive images -DICOM storage SCP3. Support DICOM 3.0input	Same as predicate,except:- support additionalcolor (YBR)interpretationswith US images- support saving	Equivalent. Addingmodifications underDICOM protocol doesnot impact the devicesafety andeffectiveness. Theseenhancements
Feature	Predicate DeviceCentricity UniversalViewer(K150420)	Subject DeviceCentricity UniversalViewerwith Cath Tools	Discussion ofDifferences
	presentation states	image calibrationinformation inPresentationState	provide informationto be used in thesame way as thepredicate, for thesame purpose and bythe same users.
(XED) CrossEnterpriseDisplay	Provides the ability toview patient informationacross multipleenterprise sites based onmatching patient IDnumbers.	Same as predicate,except:- New API to accesspatient history inFHIR format andfrom differentsources- Enhance ability togroup studiesanatomically- matching patientstudies fromremote sites withthe same patient	Equivalent. Addingmodifications undercross enterprisedisplay does notimpact the devicesafety andeffectiveness. Theseenhancements allowpatient history to beused in the same wayas the predicate, forthe same purposeand by the sameusers.
UserEnvironment	Designed to be utilizedinside and outside ofradiology and cardiology	Identical topredicate device	No change
Designed to beutilized insideand outside ofradiology

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Image /page/8/Picture/0 description: The image contains the logo for GE Healthcare. The logo consists of a circular emblem on the left and the text "GE Healthcare" on the right. The emblem is blue and features a stylized "GE" monogram. The text "GE Healthcare" is in a bold, sans-serif font.

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Image /page/9/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a blue circular emblem with a stylized "GE" inside, followed by the text "GE Healthcare" in a bold, sans-serif font. The text is black and positioned to the right of the emblem.

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Image /page/10/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a blue circular emblem with a stylized "GE" inside. To the right of the emblem, the words "GE Healthcare" are written in a bold, sans-serif font. The text is black, providing a strong contrast against the white background.

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Image /page/11/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a blue circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the words "GE Healthcare" are written in a bold, sans-serif font. The text is black, providing a strong contrast against the white background.

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Image /page/12/Picture/0 description: The image shows the logo for GE Healthcare. The logo consists of a blue circular emblem with a stylized "GE" monogram inside. To the right of the emblem is the text "GE Healthcare" in a bold, sans-serif font. The text is black and stands out against the white background.

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Image /page/13/Picture/0 description: The image contains the GE Healthcare logo. The logo consists of a circular emblem with the letters 'GE' intertwined in a stylized font. To the right of the emblem, the words 'GE Healthcare' are written in a clear, sans-serif font. The emblem is in blue, while the text is in black.

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Image /page/14/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a blue circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the words "GE Healthcare" are written in a simple, bold, sans-serif font. The text is black, contrasting with the white background.

VII. PERFORMANCE DATA

Summary of Non-Clinical Tests

The software documentation was provided for a moderate level of concern device following the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

The Centricity Universal Viewer with the proposed modifications has been verified against design requirements and validated against defined user needs and intended uses, in accordance with the voluntary standards as detailed in this premarket notification submission. The same Cath Tools features were previously cleared in the premarket notification K063628.

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Image /page/15/Picture/1 description: The image shows the logo for GE Healthcare. The logo consists of the letters 'GE' in a stylized blue circle on the left. To the right of the logo is the text 'GE Healthcare' in black font. The text is aligned horizontally with the logo.

The performance characteristics of the Centricity Universal Viewer has been verified against design requirements and validated against defined user needs and intended uses as follows:

Validation of user needs and intended uses was performed using the recommended hardware platform
System verification testing of system level requirements was performed using the recommended hardware platform
· Regression testing included in verification testing
Integration and interoperability verification testing of software functional requirements
· Unit testing of Product Design Detail (PDD) statements
· Product usability formative and summative testing
· Cybersecurity analysis

The subject of this submission, Centricity Universal Viewer, did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing.

VIII. CONCLUSION

A comparison of the Intended Use / Indications for Use, the technological characteristics, and performance specifications demonstrate the functional equivalence of the subject device to the predicate device.

Verification and validation testing demonstrate that the Centricity Universal Viewer continues to provide a reasonable assurance of safety and effectiveness with respect to the intended use of each feature. Regression testing confirmed that changes did not affect previously cleared features of the Centricity Universal Viewer.

The Centricity Universal Viewer device will continue to have an intended use and functionality fitting within the definition of 21 CFR 892.2050, Picture Archiving and Communication Systems, Product Code LLZ.

Information provided in this premarket notification submission supports the Centricity Universal Viewer medical device to be as safe, as effective and substantially equivalent to its predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).