VOX/BASE FOR WINDOWS

{0}------------------------------------------------ J-MAC VOX/ BASE System 510(k) Notification # OCT 27 1997 #### 510(k) Summary ## K972933 #### J-MAC VOX/BASE System for Windows Common classification name: Digital Image Communications System (PACS) J-MAC Systems, Inc. Oda Building 10-1 Kita 9 Nishi 3 Kita-ku, Sapporo, 060, Japan Phone: 81-11-726-6262 81-11-726-6260 Fax: Contact Person: Sheila W. Pickering Ph.D. 320 Fairway Drive Half Moon Bay, California 94019 Telephone/Fax 415 726 3223 ### A. Legally Marketed Predicate Device The J-MAC VOX/BASE for Windows is substantially equivalent to the RadWorks Medical Imaging Software (K962699) manufactured by Applicare Imaging, Inc, as well as other PACS systems. The J-MAC device is substantially equivalent to the RadWorks predicate device with regard to device features and specifications, as well as intended use. Both devices are stand alone PACS software systems with similar operating requirements, and both comply with DICOM 3.0 and ACR-NEMA 2.0. Both are Windows based applications. Both products are intended for use with Computed Tomography (CT), Magnetic Resonance Imaging (MRJ), Computed Radiography (CR), Digital Subtraction Angiography (DS), Nuclear Medicine (NM), Ultrasound (US), Endoscopy (ES), Radiographic imaging (RG), and other modalities. , ### B. Device Description The J-MAC VOX/BASE for Windows is a stand alone software product which allows medical professionals to view, retrieve, store, import, process and transmit medical images over networks or phone lines. This type of product is commonly referred to as a Picture Archival and Communication System (PACS). The software consists of four modules: Query, Receive, View and Manager. The function of each is as follows: - 1. Query This module implements the Query and Retrieve DICOM Services as a Service Class User. It calls functions in the WinSock library to connect to a remote Image Server using the TCP/IP network protocol. {1}------------------------------------------------ - 2. Receive This module implements the Storage DICOM Services as a Service Class provider. It calls functions in the WinSock library to accept connections from a remote Service Class User using the TCP/IP network protocol. - 3. View this module contains tools for - basic image processing (flipping, rotating, inverting) . - screen layout (cell dimensions and arrangement, colors, font) . - image management (magnifying lens, zoom, select, hide, scroll) ● - 4. Manager This module provides a convenient way of knowing which images are already stored locally. ## C. Intended Use The device is intended to display various image data used in a hospital, clinic, physician's office and other health care settings. It handles data from CR, CT, DS, MR, NM, US, ES, RG and other modalities. The J-MAC system is an accessory to diagnostic imaging devices, it is not a diagnostic device. The J-MAC VOX/BASE System User Manual provides warnings and precautions regarding intended use, and detailed information on system operation. {2}------------------------------------------------ ﻳﻮ J-MAC VOX/ BASE System 510(k) Notification ## D. Substantial Equivalence | | Predicate Device | Submission Device | | |------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------| | Product Name | RadWorks Medical Imaging Software<br>K962699 | J-MAC VOX/Base/Windows<br>Medical Imaging Software | Substantially<br>Equivalent | | Intended Users | Medical professionals working in image<br>analysis and management | Medical professionals working in image<br>analysis and management | yes | | Site of Use | Hospitals, clinics, remote health care<br>facilities | Hospitals, clinics, remote health care<br>facilities | yes | | Languages | English | Japanese and English | yes | | Software structure | Modular design | Modular design (4 modules: Query, Receive, View, Manager) | yes | | Compliance with<br>standards | Complies with DICOM 3.0 and<br>ACR-NEMA 1.0 or 2.0 or proprietary | Complies with DICOM 3.0 and<br>ACR-NEMA 1.0 or 2.0 or proprietary | yes | | Operating System | Microsoft Windows NT | Microsoft Windows 95, Windows NT3 3.51, 4.0 or later | yes | ◆ 【 ﻤﺴﺴﺴﺴﺴﺴ {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, symbolizing the department's mission to protect the health of all Americans. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 27 1997 Sheila W. Pickering, Ph.D. J-MAC Systems, Inc. c/o Wilson Sonsini Goodrich & Rosati 320 Fairway Drive Half Moon Bay, CA 94019 Re: K972933 VOX/BASE™ for Windows Dated: August 5, 1997 Received: August 8, 1997 Regulatory class: Unclassified Procode: 90 LLZ Dear Dr. Pickering: We have reviewed your Section 5100k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 misbranion. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, h.T. Kiau Yui Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a series of handwritten characters. The characters appear to be numbers and possibly letters. The characters are written in black ink on a white background and are somewhat stylized. J-MACVON BASF. 510(k) Notification #### FDA Submission Cover Sheet 510(k) Number (if known): Not applicable Device Name J-MAC VOX/BASE for Windows Indications For Use: The J-MAC VOX/BASE for Windows is a stand alone software product which allows medical professionals to view, retrieve, store, import, process and transmit medical images over networks or phone lines. This type of product is commonly referred to as a Picture Archival and Communication System (PACS). It is intended to display various image data used in a hospital, clinic, physician's office and other health care settings. It handles data from CR, CT, DS, MR, NM, US, ES, RG and other modalities. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrance Of CDRH, Office Of Device Evaluation (ODE) | Prescription Use | <span style="text-decoration: overline;">✓</span> | OR | Over-The-Counter Use | <span style="text-decoration: overline;"></span> | |---------------------|---------------------------------------------------|----|----------------------|--------------------------------------------------| | (Per 21CFR 801.109) | | | | | (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | 510(k) Number | K972933 | |---------------|---------| |---------------|---------|