RAYPAX SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for RAYPAX. The logo has a large letter R on the left side, followed by the letters AYPAX. Below the letters AYPAX is the text "medical image center" in a smaller font. www.raypax.com Ko8 19 Traditional 510(K) # 1. 510(k) Summary ## SEP 1 9 2008 #### 510(K) Owner Information (807 92(a)(1)) 1.1 | Summary Preparation Date: | April 2, 2008 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Company Identification: | RAYPAX Inc.<br>14251 E. Firestone Blvd<br>La Mirada, CA 90638 | | Contact Person: | Chris Chung<br>14251 E. Firestone Blvd<br>La Mirada, CA 90638<br>Phone: (562) 921-8640<br>Fax: (626) 270-4099<br>Email: chris@raypaxusa.com | ## 1.2 Device Identification (807 92(a)(2)) | Device Trade Name: RAYPAX System | |-----------------------------------------------------------------------| | Common/Usual Name: Picture Archiving and Communications System (PACS) | | Classification Names: System, Image Processing, Radiological | | Regulation Medical Specialty: Radiology | | Product Code: LLZ | | Regulation Number: 892.2050 | | Device Class: 2 | #### 1.3 Predicative Device Information (807 92(a)(3)) | 510(k) Number | K043415 | |-----------------------------------|---------------------------------------------| | Device Name | CENTRICITY PACS SYSTEM | | Applicant | MEDICAL SYSTEMS INFORMATION<br>TECHNOLOGIES | | Regulation Number | 892.2050 | | Classification Product Code | LLZ | | Date Received | 12/13/2004 | | Decision Date | 01/21/2005 | | Decision | Substantially equivalent (SE) | | Classification Advisory Committee | Radiology | {1}------------------------------------------------ Image /page/1/Picture/2 description: The image contains a logo for "RAYPAX". The logo is in black and white and features a stylized letter "R" followed by the letters "AYPAX" in a smaller font. Below the letters "AYPAX" is a tagline in an even smaller font, which is difficult to read due to its size and resolution. The overall design is simple and modern. ## 1.4 Device Description (807 92(a)(4)) The RAYPAX System is a complete PACS package to receive medical images from medical modalities, and distribute medical images and reports to enable medical staff to verify, diagnosis, and refer them in multi medical facilities. It consists of RAYPAX PACS server, Getaways and Clients. ### 1.4.1 RAYPAX PACS Server RAYPAX PACS server stores the images and information obtained from the medical equipments and other systems, and provides a connection for RAYPAX client to access the information depending on their previledge level. Remote access through the Internet is allowed, and to ensure a secure data transfer, strong data encryption(SSL) is provided. All DICOM images acquired in the RAYPAX System are stored unaltered and all display manipulations and annotations are stored as presentation parameters and they do not alter the original image file. ### 1.4.2 RAYPAX Gateways RAYPAX Gateways communicate with medical modalities and other systems to receive and share image data, patient demographics, order schedule and study results. DICOM Gateway gathers medical exams from modalities and other system in DICOM format. Remote exams are gathered by Net Point or Lite locally and sent to PACS server through the internet. HL7 Gateway exchanges the patient and order information, study results with other information system in HL7 standard. #### 1.4.3 RAYPAX Clients The clients of RAYPAX System are intended for diagnostic and analysis by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. RAYPAX Clients connect the PACS server and enables medical staff to view medical data and assign special tasks in the PACS workflow. OCW is a verification tool for a technician to reconstruct, verify exams. DW (Diagnostic Workstation) and RW (Review Workstation) are for the radiologist to perform diagnostic analysis of the exams. TW (Transcription Workstation) is a tool for the trancriptionist to create a preliminary report. WCC (Web Client Component) is a radiology referring tool for a physican to refer exam and report viewing at remote site. Net, Exp and Web versions of RAYPAX clients are intended to offer a remote access to the images through the Internet. For PACS administrators, Admin provides with user management, server parameter setting, and Net Monitor provides the status of the PACS system and the performance of the medical organization. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for RAYPAX. The logo has a large, stylized letter "R" on the left, followed by the letters "AYPAX" in a smaller, sans-serif font. Below the letters "AYPAX" is the text "makes medical images online" in a smaller font. The logo is black and white. #### 1.5 Intended Use (807.92(a)(5)) #### 510(k) Number (if known): Device Name: RAYPAX System The RAYPAX System is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images acquired from 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), Film Scanners, and any other DICOM supporting devices. The clients of RAYPAX System are intended for diagnostic and analysis tool by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. OCW (Quality control Workstation) is intended to verify exams, DW (Diagnostic Workstation) and RW (Review Workstation) is intended for radiologists to diagnostic analyze exams and WCC (Web Client Component) is intended for clinical review of physicians. Net Point and Lite are intended to acquire exams from local modalities and send the exams to the PACS server through the Internet. Net, Exp and Web versions of RAYPAX clients are intended to offer a remote access to the images through the Internet. For the digital mammography images, to be viewed for primary interpretation, images must be acquired from an FDA approved Mammography device for primary interpretation and viewed on a display system with at least 5 Mega Pixel of resolution and has been cleared by the FDA for diagnosis of digital mammography images. Furthermore, the Mammography device must be able to provide, to the RAYPAX System, a viewable DICOM 'for presentation' mammography image. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images. ### 1.6 Technological Characteristics (807.92(a)(6)) RAYPAX System is a standalone software package based on standard Microsoft technology, general purpose software and hardware platform. As a development tools, industry standard programming languages (C#, C++, and ASP) and the Microsoft Visual Studio are used. To create remote applications, web protocols and Microsoft Dot NET framework are used. RAYPAX System is a DICOM 3.0 compliant system to receive images from medical device, and supports HL7 (Health Level Seven) to communicate with other information system. The system only uses IP address on LAN (Local Area Network) environment to communicate with medical device, and it has no contact with patient, nor does it control any life sustaining device. All display manipulations and annotations in RAYPAX clients are stored as presentation parameters not to alter the original image file, so all DICOM images acquired in the RAYPAX System are stored and unaltered. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for Raypax, a medical imaging solutions company. The logo features a stylized letter "R" in bold, followed by the text "AYPAX" in a smaller, sans-serif font. Below the company name is the tagline "Next in Medical Imaging Solutions." #### Substantial Equivalence Discussion (807.92(b)(1)) 1.7 The predicative device and the RAYPAX System present similar indication for use statements. The Centricity PACS and RAYPAX System are Picture Archiving and Communication System. They are used to manage medical images and data, images are acquired from devices through the DICOM standard, and both systems are used by trained healthcare professionals for diagnosis. Both the predicative device and the RAYPAX system employs a database, an image storage, HL-7 interfacing and DICOM services. Images are acquired into the system from DICOM supporting devices. So, the predicative device and the RAYPAX System have no contact with the patient, nor does it control any life sustaining device. A physician, providing ample opportunity for competent human intervention interprets images and information being printed. The RAYPAX System is as safe, as effective, and performs as well as the predicate devices. Any differences between the RA YPAX system and the substantially equivalent system have no significant influence on safety and effectiveness. ## 1.8 Conclusion 807.92(b)(3) We believe that The 510(k) Pre-Market Notification for RAYPAX System contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. RAYPAX System has been and will be manufactured in accordance with the mandatory and voluntary standards listed in this submission. The submission contains the result of the hazard analysis that there is no software component in the RA YPAX System that we know of whose failure or design flaw would result in death of injury to a patient, and the "Level of Concern" of the RAYPAX System is "minor". {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure with three lines extending upwards, resembling a person embracing the world. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # SEP 1 9 2008 Mr. Chris Chung Engineer RAYPAX, Inc. 14251 E. Firestone Blvd. LA MIRADA CA 90638 Re: K081948 Trade/Device Name: RAYPAX System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 27, 2008 Received: July 8, 2008 Dear Mr. Chung: 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 10 abounded in the 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, the refore, 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 (PMA), 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. {5}------------------------------------------------ #### Page 2 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. forque M. Whang Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ RAYPAX *makes medical images accessible* Indications for Use Statement 510(k) Number: K081948 Device Name: RAYPAX System Indications for Use: The RAYPAX System is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images acquired from 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), Film Scanners, and any other DICOM supporting devices. The clients of RAYPAX System are intended for diagnostic and analysis tool by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. QCW(Quality control Workstation) is intended for technicians to verify exams. DW(Diagnostic Workstation) and RW(Review Workstation) is intended for radiologists to perform a diagnostic analysis of the exams and WCC(Web Client Component) is intended for the clinical review of physicians. Net Point and Lite are intended to acquire exams from remote facilities through the Internet. Net, Exp and Web client versions are intended for a remote access to the images through the Internet. For the digital mammography images, to be viewed for primary interpretation, images must be acquired from an FDA approved Mammography device for primary interpretation and viewed on a display system with at least 5 Mega Pixel of resolution and has been cleared by the FDA for diagnosis of digital mammography images. Furthermore, the Mammography device must be able to provide, to the RAYPAX System, a viewable DICOM 'for presentation' mammography image. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images. Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) AND/OR Julius Remus h Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number