3DI

{0}------------------------------------------------ K113442 Page 1 of 1 # 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h) #### Device Name Proprietary Device Name: 3Di including Viewing of Mammography images # Establishment Name and Registration Number of Submitter Name: Shina Systems Ltd. Corresponding Official: Dan Laor Sireni 6, Haifa 32972, Israel TEL: +972-4-8246632 ### Device Classification | Product Code: | LLZ | |-----------------------|---------------------------------------------| | CFR section: | 892.2050 | | Panel Identification: | Radiology | | Device Description: | Picture archiving and communications system | | Classification: | II | ## Reason for 510(k) Submission Traditional 510(k) Submission # Identification of Legally Marketed Predicate Devices K112530 3Di ## Device Description 3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications. The 3Di indications for use have been modified to include viewing of Mammography images. ### Intended use and indications for Use 3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT, Ultrasound &Mammography) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy. ### Safety & Effectiveness The device has been designed, verified and validated complying to 21CFR 820.30 regulations. The device has been designed to meet the requirements of ISO 14971 Safety standard. The quality of Mammography imaging has been validated by comparison the device imaging output to the DICOM source mammographic data. The comparison results demonstrate that the 3Di and the DICOM source mammographic data are substantial equivalent in terms of image quality. ### Substantial Equivalency It is Shina System opinion that the 3Di is substantially equivalent in terms of safety and effectiveness to the predicate device. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 FEB 1 6 2012 Shina Systems Ltd. % Mr. Dan Laor Quality and Regulatory Advisor Sireni 6 32972 HAIFA ISRAEL Re: K113442 Trade/Device Name: 3Di Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 9, 2011 Received: November 21, 2011 Dear Mr. Laor: 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 {2}------------------------------------------------ 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 with and would began finding of substantial equivalence of your device to a legally marketed nredicate 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, Mary Pastel Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K113442 Page 1 of 1 # Indications for Use 510(k) Number (if known): K113442 Device Name: 3Di Indications For Use: 3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT, Ultrasound & Mammography) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy. X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR 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) Mary S. Patil --- (Division Sign Off) (DMsion Sign-On) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety BLOK K113442 ਜੋਂ Page 1 of