FS-PACS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized graphic of what appears to be a human figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 23, 2016 EC-WEB CO., LTD. % Dr. Ke-Min Jen Official Correspondent 4F., NO. 89, Taiyuan Road, Datong Dist. Taipei City, 103 Taiwan REPUBLIC OF CHINA Re: K152034 Trade/Device Name: FS-PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 14, 2016 Received: January 20, 2016 Dear Dr. Jen: 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/ResourcesforYou/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, Michael D'Hara For Robert Ochs, Ph.D. 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) K152034 Device Name FS-PACS ## Indications for Use (Describe) The EC-WEB FS-PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using, DICOM or similar standards. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals. ### Type of Use (Select one or both, as applicable) ا 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 A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a blue circular icon with a stylized "E" in a lighter blue color. The "E" appears to be three-dimensional, with a blocky design. The icon has a glossy effect, suggesting it might be a software or application icon. The background is a gradient of light blue to white. # O.,LTD. Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) +886-2-2550-4790 Fax:+886-2-2559-8682 Web Site:www.e-web.com.tw ## B. Administrative Information # B.1 510(K) Summary of Safety and Effectiveness ## (Per 21 CFR 807.92) | Type of 510(k) Submission | Traditional | | |-------------------------------------------------------------|---------------------------------------------------------------------|--| | Basis for the submission | A New Device (There is no prior submission for the subject derive.) | | | 510(k) Submitter | EC-WEB CO., LTD. | | | | 4F., No.89, Taiyuan Rd., Datong Dist., Taipei City | | | | 103, Taiwan (R.O.C.) | | | | Telephone: +886-2-2550-4790 | | | | Fax:+886-2-2559-8682 | | | | Web: www.e-web.com.tw | | | Official Correspondent | Dr. Jen, Ke-Min | | | | TEL: +886-3-5208829 FAX: +886-3-5209783 | | | | Email: ceirs.jen@msa.hinet.net | | | Preference for Continued<br>Confidentiality (21 CFR 807.95) | 510(k) Summary | | Date Prepared January 14, 2016 FS-PACS Proprietary (Trade) Name Common Name of the Proposed Picture Archiving and Communications System Device Classification Name Regulation Number Class Panel Product Code Predicate Device Picture Archiving and Communications System 21 CFR 892.2050 II Radiology LLZ DATACOM TECHNOLOGY CORP DATACOM DC-PACS K083182 {4}------------------------------------------------ **C-WEB CO.,LTD.** No.89, Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) : +886-2-2550-4790 Fax: +886-2-2559-8682 Web Site: www.e-web.com.tw #### ● Indications For Use:: The EC-WEB FS-PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstations, image storage and printing devices using. DICOM or similar standards. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals. #### ● Device Description: The EC-WEB FS-PACS system is based on DICOM standard application. The main function of FS-PACS is about medical image management within a PACS environment. It's including image archival, retrieval and distribution of medical images. FS-PACS can support the following modality: CR, ES, NM, RF, US, CT, MG, OT, RT, XA, DX, MR, PT, SC, VR, IO, SR. There is no 3D image manipulation functions. FS-PACS provides the following measurement tools: 2-point distance, 3-point angles, ellipse area, and square area. FS-PACS can support the iOS device (i.e., iPad and iPhone). Images reviewed on the mobile device are not intended for diagnostic use. FS-PACS does not include any type of imaging hardware. It does not provide any masking or image filtering functions. #### ● Technological Characteristics: FS-PACS has multiple software components and has no imaging hardware. The FS-PACS is a software server application and does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a blue circular icon with a stylized "E" in the center. The "E" is rendered in a three-dimensional, isometric style, giving it a blocky appearance. The icon has a glossy, reflective surface, suggesting a digital or web-based context. # EC-WEB CO.,LTD. 4F., No.89, Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) Tel:+886-2-2550-4790 Fax:+886-2-2559-8682 Web Site:www.e-web.com.tw #### ● Comparison Table | Devices | Predicate device | Subject device | |--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Proprietary Name | DATACOM DC PACS | FS-PACS | | 510(k) No. | K083182 | TBA | | Manufacturer | DATACOM Technology Corp. | EC-WEB CO., LTD. | | Same Characteristics | | | | Classification<br>Name | Picture Archiving and<br>Communications System | Same | | Regulation Number | 21 CFR 892.2050 | Same | | Product Code | LLZ | Same | | Indications for Use | The DATACOMTM DC-PACS is<br>intended for the manipulation,<br>management, and display of medical<br>images. It can manage and display<br>images from different modalities and<br>interfaces and can distribute those<br>images to various workstation, image<br>storage and printing devices using.<br>DICOM or similar standards. Typical<br>users of this system are trained<br>medical professionals, including<br>physicians, nurses, technicians and<br>computer system professionals. | The EC-WEB FS-PACS is<br>intended for the<br>manipulation, management,<br>and display of medical<br>images. It can manage and<br>display images from<br>different modalities and<br>interfaces and can distribute<br>those images to various<br>workstation, image storage<br>and printing devices using.<br>DICOM or similar<br>standards. Lossy<br>compressed<br>mammographic images<br>and digitized film screen<br>images must not be<br>reviewed for primary<br>image interpretations.<br>Mammographic images<br>may only be interpreted<br>using cleared monitors<br>intended for | | | | mammography display.<br>Typical users of this system<br>are trained medical<br>professionals, including<br>physicians, nurses,<br>technicians and computer<br>system professionals. | | Networking<br>Communications<br>Protocol | DICOM 3.0 | Same | | DICOM<br>C-Store Service | DICOM Workstation can use this<br>function to send the DICOM file to<br>PACS | Same | | DICOM<br>C-Echo Service | DICOM Workstation can use this<br>function to verify the<br>DICOM service of PACS | Same | | DICOM<br>Query/Retrieve<br>Service | PACS Viewer can use this function<br>to search with PACS, and view the<br>DICOM image from PACS. | Same | | DICOM<br>C-Find Service | DICOM Workstation can use this<br>function to get patient information<br>from PACS. | Same | | DICOM Image<br>backup system | Backup DICOM images and<br>database | Same | | Different Characteristics | | | | DICOM<br>Multi-port<br>C-Store Service | None | PACS can set multi-port to<br>retrieve DICOM images<br>from DICOM Workstations<br>in hospital. | | Customize Paper<br>Print | None | PACS Viewer can use this<br>function to customize the<br>print layout. | | Dental Template | None | PACS has dental template to<br>view the intraoral DICOM<br>image.<br>This dental template can be<br>customized by user. | | Client Viewer<br>Login User<br>Permission | None | PACS has permission to<br>control every accounts and<br>limit their functions for user | | Capture DICOM<br>image during<br>recording | None | Capture workstation<br>can capture image during<br>recording | | Convert document<br>file to DICOM<br>image | None | Gateway can convert<br>document file or send to<br>PACS. | | Convert digital<br>image to DICOM<br>image | None | Gateway can convert digital<br>image to DICOM image and<br>send to PACS with mobile<br>device. | | Access DICOM<br>image<br>from Internet | PACS provides Web-Viewer to<br>access DICOM image from Internet | Web-Viewer can invite and<br>synchronize exam images<br>with other online user. | | Parse the DICOM<br>SR (Structure<br>Report) file | None | FS-Workstation can parse<br>the DICOM SR (Structure<br>Report) file and insert the<br>measurement value to<br>customize report by user. | | Monitoring<br>FS-PACS program | None | A monitor program to get<br>status from all of FS-PACS<br>program, when one of<br>FS-PACS program gets<br>error, it will restart that<br>program automatically. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a glossy, circular icon with a blue color scheme. Inside the circle, there is a stylized, three-dimensional shape that resembles a series of interconnected blocks or the letter 'W' repeated and layered. The shape is also in varying shades of blue, creating a sense of depth and dimension within the icon. # EC-WEB CO.,LTD. 4F., No.89, Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) Tel:+886-2-2550-4790 Fax:+886-2-2559-8682 Web Site:www.e-web.com.tw {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a blue, circular logo with a stylized, three-dimensional "W" in the center. The "W" is also blue and appears to be made of stacked blocks, giving it a geometric and modern look. The logo has a glossy, reflective effect, suggesting a digital or web-based context. The background is a gradient of light blue, fading from a lighter shade at the top to a slightly darker shade at the bottom. # EC-WEB CO.,LTD. 4F., No.89, Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) Tel:+886-2-2550-4790 Fax:+886-2-2559-8682 Web Site:www.e-web.com.tw {8}------------------------------------------------ No.89, Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) Tel: +886-2-2550-4790 Fax: +886-2-2559-8682 Web Site: www.e-web.com.tw #### ● Substantial Equivalence (SE) Discussion A claim of substantial equivalence is made to DATACOM DC-PACS (K083182). Both of them have the similar indications for use, the same working principle and technologies. The extra statement about the mammographic images for the subject device provides more safety consideration than the predicate device. The other differences are due to the feature design aspects, not related to the safety and effectiveness aspects. This submission contains the results of software validation that the risks analysis and the potential hazards have been classified as Moderate Level of Concern. Thus they are substantially equivalent. #### ● Synopsis of Test Methods and Results Non-clinical data are employed upon submission of this 510(k) premarket notification according to the FDA guidance document. Guidance for Industry: Guidance for the Submission of Premarket Notifications for Medical Image Management Devices. Document issued on: July 27, 2000. #### ● Conclusion The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.