IPACS PRISM-5.0

{0}------------------------------------------------ K050298 FEB 2 8 2005 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. Date Prepared: February 1, 2005 Submitter's Information: 21 CFR 807.92(a)(1) RealTimelmage Inc. Zvi Eintracht, CEO 1111 Bayhill Dr, Suite 290 San Bruno, CA 94066 Tel: 650.616.4671 Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) iPACS Prism-5.0 ™ Trade Name: Picture Archiving Communications System Common Name: 892.2050 LLZ Device Classification: System, Image Processing Name: Predicate Device: 21 CFR 807. 92(a)(3) SYSTEM. IMAGE PROCESSING, Device Classification Name RADIOLOGICAL vice Classification Name RADIOLOGICAL | Regulation Number | 892.2050 | |-------------------|-------------------| | 510(k) Number | K030751 | | Device Name | iPACS Prism | | Applicant | RealTimelmage Inc | | Product Code | LLZ | ## Device Description: 21 CFR 807 92(a)(4) iPACS Prism-5.0 is a modified version of iPACS Prism (K030751). Both devices are picture, archiving and communications system software applications from RealTimelmage. The main significant difference between the modified device and the predicate device is that the modified device will now allow display of presentation quality digital mammography images, sent via the DICOM standard in order to make viewing of these images more convenient for the user. Both systems are a complete PACS solutions designed to be Internet friendly for easy deployment over local area networks and/or wide area networks. IPACS Prism-5.0 is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism-5.0 are needed The system is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism are needed. iPACS™ handles various images and data objects in a Picture Archive and {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "RealTime" in a simple, sans-serif font. The text is stacked vertically, with "RealTime" on top and "Image" below it. The text is in a dark color, likely black, against a white background, providing a clear contrast. Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously. Indications for Use: 21 CFR 807 92(a)(5) iPACS Prism-5.0™ is a device that receives medical images, (including mammographic images), and data from various imaging sources. Images and data can be stored, communicated, processed and displayed - within the system and or across computer networks at distributed locations. iPACS Prism-5.0TM only supports lossless compression for primary mammography image interpretation. Lossy compressed or digitized screen film mammoqraphic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions and other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including physicians, nurses, and technicians. Technological Characteristics: 21 CFR 807 92(a)(6) The device is medical device image management and processing software that is used with computer hardware in a picture archiving and communications system user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. ## Conclusion: 21 CFR 807 92(b)(1) The 510(k) Pre-Market Notification for iPACS Prism-5.0™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Real Time Image, Inc. % Mr. Carl Alletto Official Correspondent OTech, Inc. 1600 Manchester Way CORINTH TX 76210 USA Re: K050298 FEB 2 8 2005 Trade/Device Name: iPACS Prism-5.0TM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 1, 2005 Received: February 7, 2005 Dear Mr. Alletto: We have reviewed your Section 510(k) premarket notification of intent to maket the device referenced in We have reviewed your Section 510(x) premainent (for the indications for use stated in above and have determined the device is substantially equivale commerce prior to above and have determined the devices in subcessmarketed in interstate commerce prior to the enclosure) to legally marketed predicate devices marketed in to devices that have the enclosure) to legally marketed predical Device Amendments, or to devices that have been May 28, 1976, the enactment date of the Medical Device Amera, and Cosmatic Act (Ac May 28, 1976, the enactment date of the Federal Food, Duy, and Cosmetic Act (Act) that reclassified in accordance with the proval application (PMA). You may, therefore, market the do not require approval of a prematics approval approval controls provisions of the Act device, subject to the general controls provisions of the Act. The provisions provise device, subject to the general controls of the Fee. "The games. 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 (Prematket If your device is classified (see above) into entrols. Existing major regulations affecting your Approval), it may be subject to such additions, Title 21, Pars 800 to 898. In addition, FDA device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 89 device can be found in the Code of Pour device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s Issuance of a subscannlies with other requirements of the Act all FDA has made a determination mar your device edmins. You must comply with all the Federal statules and regulations administered by other registration (21 CFR Part 807); abeling (4) Act 's requirements, including, but not in registerents as set forth in the quality systems (QS) (21 CFR Part 801); good manufacturing practice requirements as set fortysions (2) CFR Part 801); good manufacturing practice the electronic product radiation control provisions regulation (21 CFR Part 820); and i Tapplicable, the electronic product rad (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) This letter will allow you to begin maketing your advice of your device of your device to a legally premarket notification. The FDA finding of substantial equivalend this p premarket notification. The FDA Inding of substantial equil and thus, permits your device to procced 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 labering regarance ( 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, "Wisornion on your responsibilities under the Act from the 807.97). You may obtain other gelleral miornation on your respections 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. Sincercly 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}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the words "RealTime Image" stacked on top of each other. There is a large black square in the upper left corner of the image. There is also a smaller black square to the left of the word "RealTime". The text is in a simple, sans-serif font. Page 1 of -1 ## (Indications for Use Form) Koso298 510(k) Number: iPACS Prism-5.0TM Device Name: Indications for Use: iPACS Prism-5.0™ from Real Time Image Inc. is a device that receives medical images, (including mammographic images), and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. iPACS Prism-5.0TM only supports lossless compression for primary mammography image interpretation. Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. manimographis inflagurer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions ind other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including physicians, nurses, and technicians. (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 (Optional Format 1-2-96) David Ro. Strymm (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _