Collage

{0}------------------------------------------------ Image /page/0/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 a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 4, 2015 Anatomage Inc. % Mr. Sean Xu Program Director 111 N. Market Street. #500 SAN JOSE CA 95113 Re: K150976 Trade/Device Name: Collage Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 14, 2015 Received: April 15, 2015 Dear Mr. Xu: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Robert A Ochs Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K150976 Device Name Collage #### Indications for Use (Describe) Collage is a software application intended for viewing of 3D medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound as well as 2D patient images, such as patient photographs, intraoral photographs, and dental x-rays. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. It is intended for use by doctors, clinicians, and other qualified individuals utilizing standard PC hardware. This device is not indicated for mammography use. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: underline;"><b> </b></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 5. 510K Summary | Submitter | Anatomage Inc.<br>111 N. Market Street #500<br>San Jose, CA 95113<br>Phone: (408) 885-1474<br>Fax: (408) 295-9786 | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Contact Person | Sean Xu, Program Director<br>Phone Number: (408) 885-1474 ext 108 | | Device Name | Collage | | 510(k) Preparation Date | 04/08/2015 | | Common Name | System, Image Processing, Radiological | | Classification | Class II | | Classification Name | Imaging Processing System, LLZ, 21 CFR 892.2050 | | Product Code | LLZ, 21 CFR 892.2050 | | Device Description | Collage is an interactive imaging software used for the<br>visualization, storage, and management of 3D medical image files<br>from scanning devices, such as CT, MRI, or 3D Ultrasound as<br>well as 2D patient images, such as patient photographs, intraoral<br>photographs, and dental x-rays. Doctors, dental clinicians, and<br>other qualified individuals can retrieve, process, render, review,<br>store and print images, utilizing standard PC hardware. The<br>software runs in Windows operating systems and visualizes<br>medical imaging data on the computer screen. The Collage<br>software is intended as a platform bridging different sets of patient<br>data for comprehensive studies. With Collage software, doctors<br>can manage all of their patient images, including both 2D and 3D<br>image data, in a single software. | | Intended Use | Collage is a software application intended for viewing of 3D<br>medical image files from scanning devices, such as CT, MRI, or<br>3D Ultrasound as well as 2D patient images, such as patient<br>photographs, intraoral photographs, and dental x-rays. Images and<br>data can be stored, communicated, processed and displayed within<br>the system and or across computer networks at distributed<br>locations. It is intended for use by doctors, clinicians, and other | | Equivalent Devices | K101342, OsiriX MD | | Technological Characteristic | Collage is a software that handles digital medical images. This<br>device does not contact the patient, nor does it control any life<br>sustaining devices. Diagnosis is not performed by this software<br>but by doctors, clinicians and other qualified individuals. A<br>physician, providing ample opportunity for competent human<br>intervention, interprets images and information being displayed<br>and printed.<br>Collage is installed on standard off-the-shelf x86 processor based<br>computers running the Windows operating system. | | Non-Clinical Test Results | The following quality assurance measures were applied to the<br>development of the system:<br>· Risk Analysis<br>· Requirements Reviews<br>· Design Reviews<br>· Performance testing<br>· Usability testing<br>· Final acceptance testing<br>· Bench testing to compare with predicate software<br><br>Testing confirmed that the software is stable and operating as<br>designed. Testing also confirmed that the software has been<br>evaluated for hazards and that risk has been reduced to acceptable<br>levels.<br><br>Bench testing of the software with predicate software was<br>performed by evaluation of images rendered by Collage and<br>predicate software. This testing and evaluation included testing of<br>rendering both 2D and 3D images in both predicate and subject<br>software and was evaluated by an expert in the field of radiology.<br>This testing confirms that Collage is as effective as its predicate in<br>its ability to perform its essential functions of rendering and<br>managing medical images. | | Summary | Based on the intended use, product, performance, and testing<br>information provided in this notification, the subject device has<br>been shown to be substantially equivalent in the area of technical<br>characteristics, general functionality, and indicated use to the<br>currently marketed predicate device and does not introduce any<br>new potential risks. | {4}------------------------------------------------