STENTOR, PAGEVIEW

{0}------------------------------------------------ OCT 25 1999 Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the number '99', then '26', and ends with '98'. The handwriting appears somewhat cursive and the numbers are written closely together. # 510(k) SUMMARY In accordance with the provisions of the Safe Medical Device Act of 1990, m accordance with the provisional of safety and effectiveness information regarding the PageView software. - Company Identification 1.1 Stentor, Inc. 385 Oyster Point Blvd. Suite 8B South San Francisco, CA 94080 Tel: (650) 866-4100 Fax: (650) 866-4197 - Official Correspondent 1.2 Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA, USA, 94578-1116 (510) 276-2648 Tel: (510) 276-3559 Fax: Email: regman1@home.com - Date of Submission 1.3 August 10, 1999 - 1.4 Device Name Classification Name: Common/Usual Name: Proprietary Name: PACS Teleradiology System Stentor PageView - Substantial Equivalence 1.5 The PageView software is substantially equivalent to the Mitra, Exhibit {1}------------------------------------------------ (K982769) and the Dome Imaging Systems, PACScache (K983815). #### 1.6 Device Description and Intended Use Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images. For further information about the basic architecture of the system, please refer to the Stentor System Design Document Summary. Intended Users: The PageView components are always integrated into client applications. These PageView client applications are designed to be used by people who are involved in healthcare delivery. This includes physicians, medical technologists, administrative staffs, hospital information technology staffs, and people who will support and service the PageView products. #### 1.7 Software Development Stentor certifies that the PageView software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software used in this product is used to convert DICOM images to formats that can be displayed both within web browsers as well as stand-alone applications. {2}------------------------------------------------ #### 1.8 Safety and Effectiveness ## General Safety and Effectiveness Concerns: The device labeling contains instructions for use and indications for use. The hardware components specified (but not supplied) are all "off the shelf" computer components. ## Validation and Effectiveness: Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers. ## Substantial Equivalence: The PageView software is a software package used to receive DICOM images, convert them to a web-browser compatible format, and to transfer those converted images to a viewing applet. PageView is substantially equivalent to the Mitra Exhibit product, in that it receives DICOM images, converts them to wavelet format and displays them within a web browser. The intended use and technological characteristics of the system are virtually identical to Mitra Exhibit (K982769)or the Dome Imaging Systems PACScache (K983815). Any differences between the PageView software and the equivalent devices have no significant influence on safety or effectiveness. It is our conclusion that there is no software component in the PageView product or hardware component which would be used in conjunction with the PageView product that we know of whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus the "Level of Concern" of the Stentor PageView product is "minor". {3}------------------------------------------------ ### 1.9 Substantial Equivalence Chart | Product Name | Mitra-Exhibit<br>(K982769) | Dome Imaging Systems<br>PACScache<br>(K983815) | Stentor-PageView<br>(this submission) | |---------------------------------------------------|----------------------------|------------------------------------------------|---------------------------------------| | Print to Paper Capability | Yes | Yes | Yes | | Graphical Ul | Yes | Yes | Yes | | Windows O.S. - Client | Yes | Yes | Yes | | Uses Standard. Monitor | Yes | Yes | Yes | | Scales Image to Display. | Yes | Yes | Yes | | Image Input | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 | | Images stored on remote NT<br>server | Yes | Yes | Yes | | Network Protocol | TCP-IP | TCP-IP | TCP-IP | | Compression | Wavelet | J-Peg | Wavelet | | Annotation | Yes | Yes | ત્ત્વ સ્ક્રિક | | Image Measurement | Yes | No | Yes | | Cine tool | Yes | Yes | Yes | | Comparison Mode | Yes | Yes | Yes | | Review Report from RIS | Yes | Yes | Yes | | Designed for Use Inside &<br>Outside of Radiology | Yes | Yes | Yes | | Flip / Rotate of Images | Yes | Yes | Yes | | User Log In | Yes | Yes | Yes | | Multiple Layout Options | Yes | Yes | Yes | | WW/WL control & Pre-sets | Yes | Yes | Yes | | Patient & Study Browser | Yes | Yes | Yes | . {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & WOMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 5 1999 Stentor, Inc. Gary Allesbrook C/o Regulatory Management Services 16303 Panoramic Way San Leandro, California 94578-1116 RE: K992698 Stentor PageView Teleradiology System Dated: August 10, 1999 Received: August 11, 1999 Regulatory Class: I 21 CFR 892.2020/Procode: 90 LMD Dear Mr. Allesbrook: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have have have have have We have reviewed your Section 510(i) houlder of the indications to use stated in the enclosure) to legally determined the device is substantially equivalent for the enclosur determined the device is substant for the more processor of the enatorent date of the enational date of the marketed predicate devices marked in melse phone of this novel of on one of the provisions of the provisions of the provisions of the provisions of the negeral con Medical Device Amendments, or to devices that nave been receives market the do the general control. Federal Food, Dog, and Cosmetic Act (Act). Your may, therefore, market th Federal Food, Drug, and Cosmetic Act (Ac). Tou may, the Act are activents for annual registration and cregistration, include provisions of the Act. The general controls provisions of the PRS mades of can be adulteration. devices, good manufacturing practice, labeling, and prohibitions against misbr lf your device is classified (see above) into either class III (Special Controls) or dass III (Premarket Approval), it may lf your device is classified (see above) into ether class in (rehearm (result in the contral) (e contract in the contraction in the comment in end be subject to such additional controls. Existing major regulation assumes ompliance with Federal Regulations, Title 21, Parts 800 to 85. A substantially equivation Regulat Federal Regulations, Title 21, Factice requirements, as set forth in Custimanters (GS) for States the Current Good Manufacturing Practice requirements, as set forth in the Fo the Current Good Manufacturing Pracice requirements, as set of the Crising of Sinnesgiations, the Frood and Medical Devices: General regulations Failure of the Conqly with the County with the Centrely in the Pesult in Drug Administration (FDA) will verify such assumptions. Failu Drug Administration (FDA) will venty such assumply on the che vine ring var device in the Eederal regulatory action. In addition, FDA may publish further announcering your o regulatory action. In addition, FDA may publish untitler and occisen dregondry of affect any obligation you Register. Please note: this response to your premarket notifica Register. Please note: this response to your prematics now and the Electronic Product 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 for This letter will allow you to begin marketing your device an your of your broad. In a classified in a classified in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your labeling regulation (21 CFR Part 801 and additionally for guestions on lf you desire specific advice in your device on on labelling legaler (21) 554-413. Additionally, for questions on vitro diagnostic devices), please contact the Office of Co vitto diagnostic devices), please contact the Unice of Corrise of Compliance at (301) 594-4639. Also, the promotion and advertising of your device, please contact the Offic the promotion and advertising of your eetch, pease continues on online to t (21 - 1). Other . please note the regulation entitled, "Mistranding by reference to britison of S please note the regulation entilled, "Misting of reletice to prehided from the Division of Small Manufacturers general information on your responsibilities under the Act . (1 general information on your responsibilities and the Act May 25 Stainternet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page 1 of 1 K992698 510(k) Number (if known): Stentor, PageView Device Name: Indications For Use: Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images. ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use (Per 21 CFR 901.109) Over-the-Counter Use Verid C. Sgem (Division Sign-Off) (**Optional Format 1-2-96**) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number: K992145 Medical Devices 510(k) Number K992645