ORS VISUAL

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure embracing a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle. ## APR 2 9 2010 Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Mr. John Howlett Head of BSI Medical Device Notified Body BSI Group, Product Services British Standards Instution, Maylands Avenue Hemel Hempstead, Herts HP2 4SQ UNITED KINGDOM Re: K100335 Trade/Device Name: ORS Visual Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 22, 2010 Received: March 25, 2010 Dear Mr. Howlett: This letter corrects our substantially equivalent letter of April 8, 2010. 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of {1}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Donald J. Trump Donald J. St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Notification (21 CFR 807.90(e)) ## 4. INDICATIONS FOR USE 510(k) Number: Unknown Device Name: ORS Visual ## Indications for Use: The ORS Visual is a software-based Picture Archiving and Communication System (PACS) The ORS Visual is a solware-based i leture for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and medical limage data. It provides for bonnianious; sources including CT and MRI. The ORS Visual software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained professionals such as physicians, technologicio, and for the users and that image trained physician, reviewed that the software is installed on appropriate hardware and that image responsibility to ensure that the software is installed on appropriate hardw responsibility to ensure that the Soltware is installed on Species (ORS) recommends quality is sufficalle for the cifilical application: Object Noorican College of Radiology that users of the ORS Visual software consult the appropriate American College of Ra that users of the ONO visual sonthal setting and pathology being studied. Mammographic and compressed images are not supported for viewing. The software is not intended to replace the skill and judgment of a qualified medical The solware is not intended to Teplace who have been a supropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views, and on the make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations original data set. Interpolated data may give the appearce of healthy the procent original data set. Interpolated "data may give the applical resolution may be present. ORS Visual software must be installed on a suitable commercial computer platforn. It is the ORS Visual soltware must be mstalled on a sultable ochinerali componitions are consistent with the clinical applications. Typical users of ORS Visual are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others. Prescription Use _ X (Part 21 CFR 801 Subpart D) 510K AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Doylog Braluation (ODE) CLU C Robert F. Beecher Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety K100335