IMORGON ULTRASOUND PACS SOLUTIONS

{0}------------------------------------------------ # MAY - 5 2005 ### 510(k) SUMMARY K056736 In accordance with the provisions of the Safe Medical Device Act of 1990, Sea Ridge Software, Inc., is providing a summary of safety and effectiveness information regarding the imorgan Ultrasound PACS Solutions, Picture Archiving and Communications System. - Company Identification 1.1 Sea Ridge Software, Inc. 541 Palmer Lane Menlo Park CA 94025 Establishment Registration: Application in process Owner Operator Number: Application in process Contact: Lloyd Kreuzer, President Tel/Fax: (650) 328-1037 - Official Correspondent 1.2 Gary J. Allsebrook Requiatory Management Services 16303 Panoramic Way San Leandro CA USA 94578-1116 Tel/Fax: (510) 276-2648 Email: regman10@comcast.net - Date of Submission 1.3 March 14, 2005 - 1.4 Device Name Classification Name: Common/Usual Name: Proprietary Name: Picture Archiving & Communication Sytem Soft-copy reading system imorgon Ultrasound PACS Solutions - 1.5 Substantial Equivalence imorgon Ultrasound PACS Solutions software is substantially equivalent to the Siemens (Acuson Corp.) KinetDx Picture Archiving & Communications System (K023772) . {1}------------------------------------------------ #### Device Description and Intended Use 1.6 imorgon Ultrasound PACS Solutions is a PACS system, comprised of infor guisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central that pullent and prollowed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior syocedure data, a user can access the information by selecting the item from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via internal formal, and customized is imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information. #### 1.7 Software Development Sea Ridge Software, Inc., certifies that the imorgon Ultrasound PACS Solutions software is designed, developed, tested and validated according to These procedures identify individuals within the written procedures. organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software developed for this product is used to provide diagnostic quality images and associated information to the intended users. {2}------------------------------------------------ #### Safety and Effectiveness 1.8 ### General Safety and Effectiveness Concerns: The device labeling contains instructions for use and indications for use. The hardware components specified (and optionally supplied) are all "off the shelf" computer components. ### Validation and Effectiveness: Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers. ### Substantial Equivalence: imorgon Ultrasound PACS Solutions has Indications for Use and a Target Population similar to the Siemens (Acuson Corp.) KinetDx PACS (K023772). All of the functions imorgon Ultrasound PACS Solutions performs are available in the listed substantially equivalent device. There are no significant differences between imorgon Ultrasound PACS Solutions and the predicate device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized lines forming its body and wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Sea Ridge Software, Inc. % Mr. Gary J. Allsebrook Consultant Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116 Re: K050736 Trade/Device Name: imorgon Ultrasound PACS Solutions Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system ﺠﻴ Regulatory Class: II Product Code: LLZ Dated: March 14, 2005 Received: March 21, 2005 Dear Mr. Allsebrook: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your boomer be is substantially equivalent (for the indications for use stated in above and nave determined at predicate devices marketed in interstate commerce prior to the cholosure) to regarly mantowe process in the Medical Device Amendments, or to devices that have been May 20, 1770, all chaudiness 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 approval or a provisions of the Act. The general controls provisions of the Act device, subject 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 11 your de vice is onastilional controls. Existing major regulations affecting your Apploval), it they of sabject to eat 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 I loast oc advisod that i 2211 in that your device complies with other requirements of the Act or any FDA has made a acternmation alla your as a vother Federal agencies. You must comply with all the I catal statues and regulation but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, moraling 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. MAY - 5 2005 {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin hantellig your interest of your device to a legally premarket notification. The PDA inding of Sacoxantial Print 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 If you desire specific advice for your device on our laborage of 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 prematic notification" (21 CFR Also, please note the regulation entitled, "Thisoration on your responsibilities under the Act from the 180 807.97). You may obtain other general missional and Consumer 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 {5}------------------------------------------------ Page 1 of 1 510(k) Number (if known): Ko 5 0 7 3 k #### Sea Ridge Software, Inc., imorgon Ultrasound Device Name: PACS Solutions), Picture Archiving and Communications System Indications For Use: imorgon Ultrasound PACS Solutions is a medical image and information management system that is intended to transmit, store, retrieve, print and process DICOM digital medical images and associated medical information from various ultrasound imaging systems. It may also be used for general radiogical viewing from other modalities such as MRI, CT or nuclear medicine. imorqon Ultrasound PACS Solutions is indicated for use by trained medical professionals including, but not limited to, radiologists, physicians and medical technologists. imorgon is also indicated for soft copy diagnostic interpretation of medical images and video by physicians trained in such practice. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. ## (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 901.109) | | OR | Over-the-Counter Use | | |----------------------|--| |----------------------|--| (Optional Format 1-2-96) | (Division Sign-Off) | | |---------------------------------------------------------------|---------| | Division of Reproductive, Abdominal, and Radiological Devices | | | 510(k) Number | K050736 | 510(k) Number __