CENTRICITY PACS SYSTEM

K043415 · Ge Medical Systems Information Technologies · LLZ · Jan 21, 2005 · Radiology

Device Facts

• Record ID: K043415
• Device Name: CENTRICITY PACS SYSTEM
• Applicant: Ge Medical Systems Information Technologies
• Product Code: LLZ · Radiology
• Decision Date: Jan 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The Centricity™ PACS provides scaleable image, data management and storage solutions for medical imaging. The system is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), and any other DICOM devices. The Centricity™ PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity™ PACS infrastructure. To be viewed for primary interpretation, the digital mammography images must be acquired from an FDA approved Full Field Digital Mammography (FFDM) device for primary interpretation. Furthermore, the FFDM must be able to provide, to the Centricity™ PACS, a viewable DICOM 'for presentation' mammography image as approved by the FDA for primary interpretation. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images. To be viewed for primary diagnosis, digital mammography images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The Web client software allows the user to display and manipulate images stored in the Centricity™ PACS or other DICOM archive device including the Centricity™ Enterprise Archive. The Centricity™ Web is not intended for primary diagnosis. The Centricity™ Infrastructure provides for the system's database management, storage, printing, HL-7 interfacing, and all DICOM services such as Store, Print, Query/ Retrieve, Send, etc. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.

Device Story

Centricity PACS is a software-based system for medical image management, storage, and diagnostic review. Components include Workstation, Web Client, and Infrastructure. Inputs are DICOM-compliant images from various modalities (CT, MR, MG, etc.). The system enables viewing, editing, annotation, and distribution of images. Workstation allows primary diagnosis; Web client is for clinical review only. Infrastructure manages database, storage, and HL-7/DICOM services. Operates on off-the-shelf PC hardware or turnkey solutions. Changes to image presentation are saved as display definitions, preserving original pixel data. Supports remote access via network. Benefits include centralized diagnostic workflow, scalable storage, and integration with 3rd party applications (e.g., RIS, voice recognition, 3D reconstruction).

Clinical Evidence

Bench testing only. No clinical data presented. Evidence based on verification and validation testing, including risk analysis, module verification, system integration, and performance/safety testing.

Technological Characteristics

Software-based PACS; runs on off-the-shelf PC hardware or turnkey configurations. Supports DICOM standard protocols for image storage, retrieval, and transmission. Connectivity via network/HL-7. Image formats include uncompressed, lossless, lossy, and Wavelet/Multi-resolution. Features include database management, redundancy (Media Copy, ASP Archive), and integration with 3rd party applications.

Indications for Use

Indicated for trained healthcare professionals (radiologists, physicians, technologists, clinicians, nurses) for primary diagnostic review, analysis, and management of DICOM-compliant medical images (CT, MR, CR, DX, MG, US, NM, PET, XA). Includes primary interpretation of digital mammography when used with FDA-cleared FFDM devices and displays.

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™ PACS Plus (K023557)
• Seno Advantage (K033400)

Submission Summary (Full Text)

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## Section 2 510(k) Summary of Safety and Effectiveness

| Date: | November 24, 2004 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies<br>800 Business Center Drive<br>Mount Prospect, IL 60056 |
| Contact Person: | Carol Alloian<br>Sr. Regulatory Affairs Specialist<br>GE Medical Systems, Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device: | |
| Trade Name: | Centricity ^TM PACS System |
| Common/Usual Name: | Picture Archiving and Communications Systems and Workstation |
| Classification Names: | 21 CFR 892.2050 System, Image Processing, Radiological |
| Predicate Device: | K023557: Centricity ^TM PACS Plus |
| | K033400: Seno Advantage |
| Device Description: | The Centricity ^TM PACS include the following major components:<br>Workstation, Web Client, and Infrastructure. |
| | The Centricity ^TM PACS workstation is used to view, edit,<br>manipulate, annotate, analyze, store and distribute images and<br>data that are stored and managed in the Centricity ^TM PACS<br>infrastructure for diagnosis. This software-based product<br>provides capabilities for the acceptance, transmission, printing,<br>display, storage, editing and digital processing of medical images<br>and associated data. |
| | All acquired image data is preserved in the format in which it is<br>received. Changes may be made to the presentation of the<br>images. These changes are saved as display definitions only and<br>do not alter the acquired image pixel data. Any and all display<br>definitions applied to an image can always be reversed to the<br>acquired state. |
| | The Centricity ^TM PACS workstation may also be used in a remote<br>location, away from the healthcare facility, as long as the<br>workstation has the ability to connect, via network, to the primary<br>healthcare facility where the Centricity ^TM PACS infrastructure is<br>located. |
| | The Centricity ^TM PACS Workstation extends its diagnostic and<br>productivity capabilities into the mammography reading<br>environment and may also be used for the primary interpretation<br>of digital mammography images. |
| | The Centricity ^TM PACS Workstation can also provide the<br>hardware and OS platform for users to integrate and operate 3rd<br>party software and/or other GE software applications such as |

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RIS, voice recognition, or advanced imaging analysis (for example 3D reconstruction, MIP/MPR, and bone templating, etc.) and view any data presented through those applications.

The Centricity™ PACS Workstation software application may be sold as software only for use with 'off the shelf' PC hardware technology that meets defined minimum specifications or as a turnkey solution integrated with hardware components to be configured to meet the users specific needs

The Centricity™ Web is an internal and external image and information distribution system for the clinical review of medical images and reports. The Centricity™ Web is not intended for primary diagnosis. The Centricity™ Web is available as a supplemental sub-system to Centricity™ PACS or as a standalone Web-based image and information distribution system.

The Centricity™ PACS Infrastructure consists of a combined set of servers and software applications, which together with the Centricity™ PACS workstation and the Centricity™ Web, make up the Centricity™ PACS.

Centricity™ Enterprise Archive delivers a complete, scalable storage solution for diagnostic images. Images can be stored in uncompressed, lossless, lossy or in Wavelet/Multi-resolution formats. The system also has the ability to send data to DICOM ready devices via the DICOM standard protocol. It is a DICOM compliant solution for image storage, retrieval and transmission. The Enterprise Archive provides redundancy in long-term storage in several ways, including Redundant Archives, Media Copy, and Application Service Provider (ASP) Archive.

The Centricity™ PACS provides scaleable image, data Intended Use: management and storage solutions for medical imaging. The system is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), and any other DICOM devices.

> The Centricity™ PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity™ PACS infrastructure.

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To be viewed for primary interpretation, the digital mammography images must be acquired from an FDA approved Full Field Digital Mammography (FFDM) device for primary interpretation. Furthermore, the FFDM must be able to provide, to the Centricity™ PACS, a viewable DICOM 'for presentation' mammography image as approved by the FDA for primary interpretation. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images.

To be viewed for primary diagnosis, digital mammography images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images.

The Web client software allows the user to display and manipulate images stored in the Centricity™ PACS or other DICOM archive device including the Centricity™ Enterprise Archive. The Centricity™ Web is not intended for primary diagnosis.

The Centricity™ Infrastructure provides for the system's database management, storage, printing, HL-7 interfacing, and all DICOM services such as Store, Print, Query/ Retrieve, Send, etc.

It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.

- Technology: The Centricity™ PACS employs the same functional scientific technology as its predicate devices
- The Centricity™ PACS System complies with the voluntary Test Summary: standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Centricity™ PACS System:
- Risk Analysis .
- Requirements Reviews ●
- Design Reviews
- Testing on unit level (Module verification) ●
- . Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing ●
- . Safety testing
- The Centricity™ PACS System is as safe, as effective, and Conclusion: performs as well as the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three streams emanating from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems % Mr. Marc M. Mouser Senior Project Engineer/ Program Reviewer Conformity Assessment Services Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K043415 Trade/Device Name: Centricity™ PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 4, 2005 Received: January 6, 2005

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have itenced your becaller be (1) personally equivalent (for the indications for use stated in above and nave decormined the all predicate devices marketed in interstate commerce prior to the closure) to regary manological Device Amendments, or to devices that have been May 26, 1770, the chactinent dato of the Federal Food, Drug, and Cosmetic Act (Act) that Icclassified in accordantes while approval application (PMA). You may, therefore, market the do not require approval or a premation of the Act. The general controls provisions of the Act device, subject to the general vetices proon, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JAN 2 I 2005

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your device is classified (000 as 11 additional controls. Existing major regulations affecting your Apployal), It may oc subject to sail. aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA active can of round minouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I reast be advised that 1271 s astal your device complies with other requirements of the Act or any FDA has made a decemination alla your as be other Federal agencies. You must comply with all the r cocrail statues and regulation but not limited to registration and listing (21 CFR Part 807); labeling Act s requirements, metading practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow your o ocgin manteling your interest of your device to a legally premarket nothication. The PDA midnig of substantial equice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your devices on the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Allso, please note the regulation entired, "Thisoration on your responsibilities under the Act from the 807.97). You may outlar other general international and Consumer Assistance at its toll-free number (800) DVNSIOI or [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K043415 filed on November 24, 2004

Device Name: Centricity™ PACS System

Indications for Use:

The Centricity™ PACS provides scaleable image, data management and storage solutions for medical imaging. The system is intended for the storage, reading, diagnostic review, analysis, medion, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Ounlear Medicanaphy (Critron Emission Tomography (PET), X-Ray Angiography (XA), and any other DICOM devices.

The Centricity™ PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to throughout the neathrive, print, and export images when connected with the Centricity™ PACS infrastructure.

To be viewed for primary interpretation, the digital mammography images must be acquired from an FDA approved Full Field Digital Mammography (FFDM) device for primary interpretation. Furthermore, the FFDM must be able to provide, to the Centricity™ PACS, a viewable DICOM ffor presentation' mammography image as approved by the FDA for primary interpretation. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images.

To be viewed for primary digital mammography images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images.

The Web client software allows the user to display and manipulate images stored in the Centricity™ PACS or other DICOM archive device including the Centricity™ Enterprise Archive. The Centricity™ Web is not intended for primary diagnosis.

The Centricity™ Infrastructure provides for the system's database management, storage, printing, HL-7 interfacing, and all DICOM services such as Store, Print, Query/ Retrieve, Send, etc.

It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Varint G. Lignm
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number