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Centricity PACSMAY - 5 2011Traditional 510(k)KSection 5 510(k) SummaryKh QPage 2of 5510(k) Summaryin accordance with 21 CFR 807.92 the following summary of information is provided:Date:Submitter:Primary Contact Person:Secodary assification Names:Product Code:February 11, 2011GE Healthcare540 W.Northwest HighwayBarrington, IL 60010Cheryl BorkRegulatory Affairs LeaderGE HealthcarePhone: 847-277-6038Fax: 847-277-5240Jeme WallaceDirector, Regulatory AffairsGE HealthcarePhone: 847-277-4468Fax: 847-277-5240Centricity PACSPACS, Picture Archiving and Communication System21 CFR 892.2050 System, Image Processing, RadiologicalLLZSecondary ProductCode:GCJ876.1500 Endoscope and accessoriesPredicate Devicels):K043415 CentricityTH PACSGE Healthcare-Confidential

Centricity PACSTraditional 510(k)Section 5 510(k) SummaryPage 3 of 5Device Description:Centricity FAGS is an enterprise grade Picture Archiving andCommunications System (FAGS) for managing digital medicalimages and associated data. Centricity FAGS enables thestorage, retrieval, distribution, printing, and presentation ofimages acquired from diagnostic imaging modalities.Centricity FAGS is a standards-based, customizable, andscalable solution supporting several of the Integrating theHealthcare Enterprise (IHE) profiles, Digital Imaging andCommunications in Medicine (DICOM), and the Health LevelSeven (HLY) protocol standards for managing digital medicalimages and patient data. Centricity FAGS supportsradiographic imaging-as in clinical radiography, cardiology,dentistry, and mammography and non-radiologic imaging,including video support.Intended Use:Gentricity FAGS software product is intended for the storage,reading, diagnostic review, analysis, annotation, distribution,printing, editing, and processing of digital images and dataacquired from diagnostic imaging devices.The Gentricity FAGS Workstation software is intended for useas a primary diagnostic and analysis tool for diagnosticimages by trained healthcare professionals, includingradiologists, physicians, technologists, clinicians and nurses. Itis also intended for use as a clinical review workstationthroughout the healthcare facility.GE Healthcare-Confidential

Centricity PACSTraditional 510(k)Section 5 510(k) SummaryTechnology:Page 4of 5Centricity PACS employs the same fundamental scientifictechnology as its predicate devices.summary ofTechnologicalCharacteristics:Predicate DeviceCentricity PACSK043415 Wv.1)Centricity PACS isa softwareDESGN product with optional turnkeyDESGN solution for hardwarecomponents.Centricity PACS isa standardsbased, customnizable, andscalable solution supportingseveral of the integrating theHealthcare Enterprise (IHE)profiles, Digital imaging andCommunications in MedicineIDICOM), and the Health LevelSeven (HL7I protocol standardsfor managing digital medicalimages and patient data.Centricity PACS supportsradiographic imaging-as inclinical radiography,cardiology, dentistry, andmammography and nonradiologic imaging, includingvideo support.Not Applicable - CentricityPACS is a software product,and therefore, has no specificmaterials of manufacture.MaterialProposed DeviceCentricity RAGS 3.2.1Centricity PACS v3.2.1 employsthe same fundamentalscientific technology as itspredicate devices, howeverv3.2.1 isa software onlyproduct,Centricity PACS is a standardsbased, customnizable, andscalable solution supportingseveral of the integrating theHealthcare Enterprise (IHE)profiles. Digital Imaging andCommunications in MedicineIDICOMI, and the Health LevelSeven IHL7I protocol standardsfor managing digital medicalimages and patient data.Centricity PACS supportsradiographic imaging-as inclinical radiography,cardiology, dentistry, andmammography and nonrodiologic imaging, includingvideo support.Not Applicable - Like thepredicate product, theCentricity PACs v3.2.1, is asoftware only product, andtherefore, has no specificof manufacture.materialsChemicalCompositionNot Applicable - CentricityPACS is a software product,and therefore, has no specificchemical composition.EnergySourceNot Applicable - CentricityPACS isa software product,and therefore, has no EnergySource.GE Healthcare - ConfidentialNot Applicable - Like thepredicate product, theCentricity PACS v3.2.1, isoasoftware only product, andtherefore, has no specificchemical composition.Not Applicable - Like thepredicate product, theCentricity PACS v3.2.1, isasoftware only product, andtherefore, has no EnergySource.

Centricity PACSTraditional 510(k)Section 5510(k) SummaryDetermination ofSubstantialEquivalence:Page 5 of 5Summary of Nan-Clinical Tests:Centricity PACS comply with voluntary standards as detailed inSection 9 of this premarket submission. The following qualityassurance measures were applied to the development of thesystem:" Risk Analysis" Requirements Reviews* Design Reviews" Testing on unit level (Module verification)" Integration testing (System verification)" Performance testing (Verification)* Safety testing (Verification)" Simulated use testing (Validation)Summary of Clinical Tests:The subject of this premarket submission, Centricity PACS, did notrequire clinical studies to support substantial equivalence.Conclusion:GE Healthcare considers Centricity PACS to be as safe, as effective,and performance is substantially equivalent to the predicatedevice(s).GE Heolthcare-Confidential

Public Health ServiceI)EPARTMENT OF HEALTH & HUMAN SERVICESFood and Drug Admiinistration10903 New Hampshire AvenueDocumient Conitrol Roomn W066-0609Silver Spring, MD 20993-0002GE Healthcare% Mr. Ned DevineSenior Staff EngineerUnderwriters Laboratories, Inc.33 Pfingsten RoadNORTHBROOK IL 60062MA5Re: K1 10875Trade/Device Name: Centricity PACSRegulation Number: 21 CER 892.2050Regulation Name: Picture archiving and communications systemRegulatory Class: 11Product Code: LLZ and GCJDated: March 29, 2011Received: March 30, 2011Dear Mr. Devine:We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.If your device is classified (see above) into class 11 (Special Controls), it may be subject to suchadditional controls. Existing major regulations affecting your device can be found in Title 21.Code of Federal Regulations (CER), Parts 800 to 895. In addition, FDA may publish furtherannouncements concerning your device in the Federal Register.Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

Page 2medical device-related adverse events) (21 CFR 803); and good manufacturing practicerequirements as sot forth in the quality systems (QS) regulation (21 CER Part 820). This letterwill allow you to begin marketing your device as described in your Section 5.1 0(k) premiarketnotification. The FDA finding Of Substantial equivalence of your device to a legally marketedpredicate device results in a classification for your device and thus, Permits your device toproceed to the market.If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 7965450. Also, please note the regulation entitled, "Misbranding by reference to prernarketnotification' (21 CFR Part 807.97). For questions regarding thie reporting of adverse eventsunder the MDR regulation (21 CFR Part 803), please go tolittpi/.wvw-A.fda. gov/Medicallbevices/Safety/ReportaProb lenm/default.hitmi for the CDRH' s Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.You may obtain other general information on your responsibilities under the Act from thleDivision of Small Manufacturers, International and Consumer Assistance ,at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet addresshtti)://www.fda.rzov/cdrh/industry/sup port/index.litmi.Sincerely Yours,Mary S. Pastel, Sc.D.DirectorDivision of Radiological DevicesOffice of In Vitro Diagnostic DeviceEvaluation and SafetyCenter for Devices and Radiological HealthEnclosure

Indications for Use FormFDA CDRH DMC4510(k) Number (if known):Device Name:.Centricity PACSMAR 302011RcieIndications for Use:The Centricity PACS provides scalable image and data management solutions formedical imaging modalities, such as Computed Tomography (CT), MagneticResonance (MR), Computed Radiography (CR), Digital X-Ray (DX), DigitalMammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron EmissionTomography (PET), X-Ray Angiography (XA), Oral X-Ray (10), Endoscopic Video(ES), and any other DICOM devices.The workstation interface software provides the user with a means to display,manipulate, archive, print, and export images when connected with the CentricityPACS infrastructure.To be viewed for primary interpretation, the digital mammography images must beacquired from an FDA approved Full Field Digital Mammography (FFOM) device forprimary interpretation. Furthermore, the FFDM must be able to provide, to theCentricity PACS, a viewable DICOM 'for presentation' mammography image asapproved by the FDA for primary interpretation. Images that are printed to film mustbe printed using a FDA approved printer for the diagnosis of digital mammographyimages.To be viewed for primary diagnosis, digital mammography images must be viewedon a display system that has been cleared by the FDA for the diagnosis of digitalmammography images.The Centricity PACS allows integration with other open interfaces, such as DICOM,to web client products and archive devices.The Centricity Infrastructure software provides for the system's database and imagemanagement, printing, HL-7 interfacing, and all DICOM services including but notlimited to, Store, Print, Query/Retrieve, and Send.It is the users responsibility to ensure quality, ambient light conditions, and imagecompression ratios are consistent with the clinical application.Prescription Use - YES(Part 21 CFIR 801 Subpart D)AND/IROver-The-Counter Use(21 CFR 801 Subpart C)Pagel1of 2NO-ri

Indications for Use Form(PLEASE DO NOT WRITE BELOW THIS LINE-CONINUE ON ANOTHERPAGE OF NEEDED)Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)DivisionSgbfOffice of In Vitro Diagnostic DeviceEvaluation and Safety510(k)X'32Page 2 of 2

The Centricity PACS allows integration with other open interfaces, such as DICOM, to web client products and archive devices. The Centricity Infrastructure software provides for the system's database and image management, printing, HL-7 interfacing, and all DICOM services including but not limited to, Store, Print, Query/Retrieve, and Send.