SAMSUNG RAYPAX LONG TERM ARCHIVE

{0}------------------------------------------------ ## 510(k) Summary of Safety and Effectiveness K99213i This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. #### Date Prepared: June 18, 1999 ## Submitter's Information: 21 CFR 807.92(a)(1) SAMSUNG SDS CO., LTD 707-19, Yoksam-Dong, Kangnam-Gu, Seoul, Korea, 135-080 ## Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Samsung RAYPAX™ Long Term Archive System Trade Name: Digital Archive Common Name: 21 CFR 892.2010 Device Classification: #### Predicate Device: 21 CFR 807. 92(a)(3) | Manufacturer: | Olicon Imaging Systems, Inc. | |----------------------------------|--------------------------------| | Device: | Olicon Imaging Systems Archive | | 510(k) Number: | K973463 | | Date Received: | 09/12/97 | | Decision Date: | 12/02/97 | | Decision: | Substantially Equivalent | | Panel Code device reviewed by: | Radiology | | Panel Code device classified by: | Radiology | | Product Code: | 90 LMB | | Classification | Class II | #### Device Description: 21 CFR 807 92(a)(4) The Samsung LTA can be part of RAYPAX PACS or can be a separate device for other manufacturer's PACS. It is used to store & retrieve digital medical images and information about the images using the DICOM 3.0 communication standard. #### Indications for Use: 21 CFR 807 92(a)(5) The Samsung RAYPAX™ Archive will be used to store & retrieve digital medical images and information about the images. The typical users are trained medical professionals. #### Technological Characteristics: 21 CFR 807 92(a)(6) RAYPAX LTA differs from some other PACS systems by having an additional storage unit management for medical images. The RAYPAX database stores and manages examination and patient information while the RAYPAX storage devices store and manage the medical images. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a stylized letter R. The letter is formed by a collection of small, irregularly shaped black dots or squares, giving it a textured, almost fragmented appearance. The background is plain white, which contrasts with the black elements of the letter. To gather medical image data, RAYPAX uses DICOM 3. Using DICOM 3.0, medical-image producing equipment requests to store medical-image data in the DICOM gateway, which acts as the gateway to the Short Term Storage (STS). The DICOM gateway, after receiving such a request, stores the medical images in the STS. All the medical images that come into the STS are stored in the Long Term Archive. If there are images that need to be highly accessible, the LTA Manager transfers it to the STS. The RAYPAX system administrator sets this transferring authority. #### Conclusion: 21 CFR 807 92(b)(1) The 510(k) Pre-Market Notification for the LTA device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. - 1. The RAYPAX™ LTA system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. - 2. This submission contains the results of a hazard analysis and all potential hazards have been classified as minor. - 3. The LTA device 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 printed. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 3 1999 Samsung SDS Co., Ltd. C/O Mr. Carl Alletto Otech, Inc. 2001 East Oakshores Drive Crossroads, TX 76227 Dear Mr. Alletto: Re: K992131 Samsung RAYPAX™ Long Term Archive Dated: June 18, 1999 Received: June 23, 1999 Requiatory Class: I (ONE) Product Code: 90 LMB 21 CFR 892.2010 We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 misbranding and adulteration. If your device is classified (see above) into either 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 requirements, 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 requlatory 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 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. 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 questions on the promotion 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/dsma/dsmamain.html". Sincerely yours, CAPT 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 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a grainy, black-and-white depiction of the letter 'R'. The letter is somewhat distorted due to the grainy texture, but its basic shape is still recognizable. The background is plain white, which contrasts with the dark, speckled appearance of the letter. ي ستخبر م Page 1 of -1 # (Indications for Use Form) 510(k) Number: K992131 ## Device Name: RAYPAX™ Long Term Archive System # Indications for Use: The Samsung RAYPAX™ Archive will be used to store & retrieve digital medical images and information about the images. The typical users are trained medical professionals. # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE # IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | |--------------------------------------------------------------------| | Division of Reproductive, Abdominal, ENT, and Radiological Devices | | Prescription Use | <div></div> | |----------------------|-------------| | 510(k) Number | K992083 | | Over-The-Counter Use | | | (Per 21 CFR 801.109) | | (Optional Format 1-2-96)