POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE

{0}------------------------------------------------ K052460 510(k) Summary of Safety and Effectiveness Date: September 13, 2005 Submitter: RamSoft Inc 16 Four Seasons Place, Suite 215 Toronto, ON M9B 6E5, CANADA Contact Name: Vijay Ramanathan Trade Names: PowerServer, PowerReader, Gateway, PowerCache Common Name: Picture Archiving and Communication System (PACS) Classification Name: LLZ - Image Processing System (892.2050) Substantially Equivalent devices: RamSoft PACS (RamSoft Inc) - K031562 Centricity PACS System (GE Medical Systems Information Technologies) -K043415 Description: The PowerServer software suite is used on general purpose computing hardware and includes the following components: PowerServer, PowerReader, Gateway, and PowerCache. As long as minimum hardware and operating system requirements are met, the user or system integrator is free to choose his/her own hardware platform. PowerServer is a scalable storage and distribution system for clinical images and data. Images can be stored in lossless or lossy formats. The system is DICOM compliant for image storage, archiving, retrieval, and transmission, and communicates with other DICOM devices. The system also communicates with PowerReader workstations and PowerCache servers. Acquired image data is preserved as captured and changes to display definitions are saved as presentation states so that images may always be reverted back to their initial state. PowerCache is a caching server that communicates with PowerServer and serves PowerReader workstations. A single PowerCache can serve multiple PowerReader workstations, reducing network traffic between PowerReader workstations and PowerServer. PowerReader is a workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data stored on PowerServer and PowerCache. PowerReader can connect directly to PowerServer and can also connect via PowerCache. PowerReader provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data. {1}------------------------------------------------ 510(k) Summary of Safety and Effectiveness Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data. Intended Use: This software is used with general purpose computing hardware for the storage, review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from imaging devices such as CR, CT, DX, MR, MG, NM, PT, RF, US, XA, film digitizers, and document scanners, and other DICOM devices. With appropriate hardware, the software is intended for use as a primary diagnostic, analysis, and review tool for use by trained healthcare professionals. It is the user's responsibility to ensure image quality, lighting, and image compression ratios are suitable for the clinical application. Digitized film should not be used for primary diagnosis in mammography. Lossy compression should not be used for primary diagnosis in mammography. Primary diagnosis on digital mammograms should not be done on any monitors other than those specifically cleared by the FDA for digital mammography applications. Film printing for digital mammography should not be performed on any printers other than those specifically cleared by the FDA for digital mammography applications. ## Technology: This device employs the same functional scientific technology as its predicate devices. ## Test Summary: This device complies with the voluntary standards as detailed in Section A.8 of the 510(k) submission. The following testing measures were applied to the development of this device: - Hazard Analysis . - Requirements Reviews . - . Design Reviews - . Code Reviews - Unit Testing t - . System Testing - Validation Testing . - Performance Testing . ## Conclusion: This device is as safe, as effective, and performs as well as predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines resembling bird wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is in black and white. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Vijay Ramanathan President and CEO RamSoft, Inc. 16 Four Seasons Place, Suite 215 Toronto, ON, M9B 6E5 CANADA SEP 2 1 2005 Re: K052460 Trade/Device Name: PowerServer, PowerReader, Gateway, and PowerCache Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 13, 2005 Received: September 14, 2005 Dear Mr. Ramanathan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your bettler by substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the enerobate) to the enactment date of the Medical Device Amendments, or to devices that have been May 20, 1770, and chance 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 do not require upproval of a provisions of the Act. The general controls provisions of the Act device, subjoct to the generation, 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 n your do role is election (t to such additional controls. Existing major regulations affecting your Apployally, It they of below 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 I DA nas made a no 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin mancing your avice of your device of your device to a legally premarket notification. The PDA miding of sabstantial of a permits 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), pleased If you desire spectic advice for your device on our laboring 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 premated notification" (21 CFR Also, please note the regulation entitled, "rinsonalists of our responsibilities under the Act from the 180 807.97). You may obtain other general miornation on Jour September Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): K052460 Device Names: PowerServer, PowerReader, Gateway, PowerCache Indications for Use: This software is used with general purpose computing hardware for the storage, review, This software is used with general purpose editing, and processing of digital images and analysis, annotation, distribution, printing, coming, conning, Can., MR, MG, NM, PT, RF, US, data acquired from imaging devices such as CR, CT, DX, MR, MG, NM, PT, RF, US, data acquired from imaging devices such as CR, OT, OT, COM devices. With appropriate XA, film digitizers, and document scauncis, and other Drognostic, analysis, and review tool for use by trained healthcare professionals. It is the user's responsibility to ensure image quality, lighting, and image compression in ratios are suitable for the clinical application. Digitized film should not be used for primary diagnosis in mammography. Lossy Digitized inin should not be used for primary diagnosis in mammography. Primary compression should not be used for primary claghests in any more of economics on the than those diagnosis on digital mammograms should not be done on any more them them them them for specifically cleared by the I DA for digital mannogan printers other than those digital mammography should not be performed on any printers other than those digital mammography should not of persons mammography applications. ## (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | X | |------------------|---| |------------------|---| -OR- Over-The-Counter Use ____________________________________________________________________________________________________________________________________________________ David h. Syam