CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION

K042525 · Ge Medical Systems Information Technologies · LLZ · Oct 1, 2004 · Radiology

Device Facts

• Record ID: K042525
• Device Name: CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION
• Applicant: Ge Medical Systems Information Technologies
• Product Code: LLZ · Radiology
• Decision Date: Oct 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

RA600/CA1000/Digital Hardcopy is intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard PC hardware. RA600 / CA1000 is intended for use as a primary diagnostic and analysis workstation in Radiology/ Cardiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration. Digital Hardcopy is intended for use primarily as a workstation for the high volume burning of CDs or DVDs containing DICOM medical images and associated diagnostic report or analysis information. CD /DVD burning and disk labeling are done via a commercially available external robotics device. RA600/CA1000/Digital Hardcopy receives imaging studies and data over LAN, WAN, intranet or internet from a PACS server or directly from a DICOM -compliant modality or archive utilizing both lossless and lossy compression. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application. The RA600/CA1000/Digital Hardcopy may interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It may be sold as software only, or as a turnkey system.

Device Story

PC-based DICOM workstation platform for medical image management; accepts images/data via LAN/WAN/internet from PACS or modalities; provides tools for display, editing, printing, and storage; supports high-volume CD/DVD burning via external robotics. Used by radiologists, cardiologists, and clinicians for primary diagnostic interpretation and clinical review. Interfaces with HIS, RIS, and CVIS. Sold as software-only or turnkey system with PC hardware, monitors, and peripherals. Facilitates clinical decision-making by providing centralized access to diagnostic images and reports.

Clinical Evidence

Bench testing only. Evidence includes risk analysis, requirements reviews, design reviews, unit-level module verification, system integration testing, final validation, performance testing, and safety testing.

Technological Characteristics

PC-based workstation; DICOM-compliant; supports lossless/lossy compression; interfaces with HIS/RIS/CVIS; includes high-resolution monitors, keyboard, mouse, and optional CD/DVD robotics. Software-based application; standalone or turnkey configuration.

Indications for Use

Indicated for viewing and diagnostic interpretation of medical images (CT, MR, CR, DR, US, XA) by trained professionals including radiologists, cardiologists, physicians, technologists, and nurses in clinical settings.

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

• Radworks Medical Imaging Software with Quality Control Module (K982862)
• Accusketch Cardiac Quantitative Analysis System with Advanced Analysis Components (K023100)

Submission Summary (Full Text)

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Kc42525

## OCT 1 - 2004

Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy Workstation
10 Submission

Section 2 Summary and Certification

| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 27, 2004 |
| Submitter: | GE Medical Systems Information Technologies<br>(Formerly APPLICARE MEDICAL IMAGING, B.V)<br>Sparrenheuvel 38<br>Zeist<br>3708 JE Netherlands |
| 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 Radiology RA600 / Centricity Cardiology CA1000 / Centricity<br>Digital Hardcopy Workstation |
| Common/Usual Name: | Picture Archiving and Communications Systems Workstation |
| Classification Names: | 21 CFR 892.2050 System, Image Processing, Radiological |
| Predicate Device: | K982862 Radworks Medical Imaging Software with Quality Control<br>Module<br>K023100 Accusketch Cardiac Quantitative Analysis System with<br>Advanced Analysis Components |
| Device Description: | Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity<br>Digital Hardcopy workstation is a PC-based DICOM workstation<br>platform which provides scaleable image and data management<br>solutions for medical imaging. This software-based product provides<br>capabilities for the acceptance, transmission, printing, display, storage,<br>editing and digital processing of medical images and associated data.<br>RA600/CA1000 / Digital Hardcopy may be combined with a PACS<br>network or connected directly to a modality through the use of DICOM<br>networking. The RA600/CA1000 / Digital Hardcopy software application<br>may be sold as a standalone product for use with 'off the shelf' PC<br>hardware that meets minimum specifications or as a turnkey solution<br>integrated with hardware components to be configured to meet the<br>users specific needs.<br>RA600 / CA1000 / Digital Hardcopy can also provide the hardware and<br>OS platform for a user to operate 3rd party software and/or other GE<br>software applications such as RIS, voice recognition, or advanced<br>imaging analysis, and view any data presented through those<br>applications.<br>RA600 / CA1000 can act as an image repository for the Centricity Web<br>Viewer application.<br>Targeted users of this system are trained professionals, including<br>radiologists, cardiologists, physicians, technologists and nurses. |

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RA600/CA1000/Digital Hardcopy is intended for viewing and diagnostic Intended Use: interpretation of images acquired from CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard PC hardware. RA600 / CA1000 is intended for use as a primary diagnostic and analysis workstation in Radiology/ Cardiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.

> Digital Hardcopy is intended for use primarily as a workstation for the high volume burning of CDs or DVDs containing DICOM medical images and associated diagnostic report or analysis information. CD /DVD burning and disk labeling are done via a commercially available external robotics device.

> RA600/CA1000/Digital Hardcopy receives imaging studies and data over LAN, WAN, intranet or internet from a PACS server or directly from a DICOM -compliant modality or archive utilizing both lossless and lossy compression. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application. The RA600/CA1000/Digital Hardcopy may interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It may be sold as software only, or as a turnkey system.

Technology: RA600 / CA1000 / Digital Hardcopy has an application interface which allows for the exchange of patient and study information, and the execution of basic application behavior commands (e.g. open study), with GE or other third party applications. This allows RA600 / CA1000 / Digital Hardcopy to interface with other applications including, but not limited to Cardiovascular Information Systems (CVIS), Radiology Information Systems (RIS), Clinical Information Systems, and other clinical software packages such as Orthopedic Templating and surgery planning software.

> The RA600/CA1000/Digital Hardcopy software application may be sold as a standalone product for use with 'off the shelf' PC hardware that meets minimum specifications or as a turnkey solution integrated with hardware components to be configured to meet the users specific needs. The RA600 / CA1000 / Digital Hardcopy Turnkey Workstation consists of a PC computing tower, software, high-resolution grayscale and/or color monitor(s), a keyboard and a mouse or other hand-based human interface device. The RA600 / CA1000 workstation can optionally include external or internal CD, DVD, or MOD drives for reading or writing to the respective media. The Centricity Digital Hardcopy Workstation uses a commercially available robotics system for automated CD or DVD publishing and disk labeling.

## COGOB

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- The RA600 / CA1000 / Digital Hardcopy 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 RA600 / CA1000 / Digital Hardcopy:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- . Final acceptance testing (Validation)
- Performance testing .
- Safety testing .
- Conclusion: The Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy Workstation is as safe, as effective, and performs as well as the predicate device.

## 000000

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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Received: September 17, 2004

OCT 1 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies % Ms. Chantel Carson CAS Manager , Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062-2096

Re: K042525

Trade/Device Name: Centricity Radiology RA600/Centrici! Cardiology CA1000/ Centricity Digital Hardcopy Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: September 15, 2004

Dear Mr. Carson:

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. 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.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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) rms letter notification. The FDA finding of substantial equivalence of your device to a legally premaints nodicate device results in a classification for your device 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 contact the Office of Compliance at one of 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 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.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

K042525

Unknown; 510(k) filed on August 27, 2004 510(k) Number (if known):

Centricity Radiology RA600/ Centricity Cardiology CA1000/ Device Name: Centricity Digital Hardcopy

Indications for Use:

RA600/CA1000/Digital Hardcopy is intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard PC hardware. RA600 / CA1000 is intended for use as a primary diagnostic and analysis workstation in Radiology/ Cardiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.

Digital Hardcopy is intended for use primarily as a workstation for the high volume burning of CDs or DVDs containing DICOM medical images and associated diagnostic report or analysis information. CD /DVD burning and disk labeling are done via a commercially available external robotics device.

RA600/CA1000/Digital Hardcopy receives imaging studies and data over LAN, WAN, intranet or internet from a PACS server or directly from a DICOM -compliant modality or archive utilizing both lossless and lossy compression. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application. The RA600/CA1000/Digital Hardcopy may interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It may be sold as software only, or as a turnkey system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Salzman

(Division Sign-Off) (Division Sign-on)
Division of Reproductive, Abdomina and Radiological Dev 510(k) Number

(Optional Format 1-2-96)

33