KIMAX REMOTE VIEWING STATION

{0}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # DEC 0 7 2001 Mr. George T. Knackstedt Director Medical Metrics, Inc. 10540 Rockley Road, Suite 200 HOUSTON TX 77099 Re: K013098 K013098 Trade/Device Name: KIMAX™ Remote Viewing Station Trade/Device Name: KIMAX™ 200 2050 TraderDevice Namber: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: August 27, 2001 Received: September 17, 2001 Dear Mr. Knackstedt: We have reviewed your Section 510(k) premarket notification of intent to market the device ty the indication of the said to since is substantially equivalent (for the indica We have reviewed your Section 5 IQ(k) prematice in univation in muirvalent (for the indications referenced above and have detectived the devices is substantially equivale referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to legally marketed prodicale devices marketed in interstate for use stated in the enclosure) to legally market predical Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enactment with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the provisions of the Rede devices that have been reclassified in accordance will the proval application (PMA). and Cosmetic Act (Act) that do ice approval of a premalces approval application (PMA). and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to may begistration, listing of general controls provisions of the Act include requirements for annual registrations and general controls provisions of the Act include requirements of the Groupen in Maranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into extrem confections affecting your device can be it may be subject to additional controls. Existing major regulations affective it may be subject to additional controls. Existing major regulations and and of your of the may found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In add found in the Code of Federal Regulations, Trilo 21, I accords 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 ts of the Act Please be advised that FDA's issuance of a substanted doler requires with other requirements of the Act that FDA has made a determination that your device complies with of th that FDA has made a determinations administered by other Federal agencies. You must or any Federal statutes and regulations anningiting by other Federal on and listi or any Federal statutes and regulations and including, but not listing the mand listing comply with all the Act's requirements, including, but not listing requirements as comply with all the Act's requirements, finciding, our not minted to reguirements as se (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirement (21 CFR Part 807); labeling (21 CFR Part 801); good manataotande for mobile, the electronic forth in the quality systems (QS) regulation (21 CFR 1000-1050. forth in the quality systems (QS) regulation (21 CFR Part 25) -542 of the Act); 21 CFR 1000-1050. product radiation control provisions (sections 531-542 of the Act); 21 CFR 1 {1}------------------------------------------------ Page 2 This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will allow you to begin marketing your device of your device to a legally marketed notification. The FDA finding of substantial equivaler and thus nemits your d notification. The FDA finding of substantial equivalence or 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), please r in the regulation If you desire specific advice for your device on our laboring agains. contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and and one one of essent of the mating. Office of Compliance at (301) 594-4639. Also, please noneral information on Office of Compliance at (301) 394-4057. Also, production) Other general information of Small Manufacture by reference to premarket notification (21 Cr F r a F orision of Small Manufacturers, your responsibilities under the Act may be obtained from the Division of Small Manufactu your responsibilities under the Act may or obtails nonemal (800) 638-2041 or (301) 443-6597 International and Consumer Assistance at 11 1 14 modemons btml International and Consumer Tissistance at the form of the main.html. Sincerely yours, Vernie C. Snodgin Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### 2013098 510(k) Application Medical Metrics, Inc. Medical Metrics, te Viewing Station ### Statement of Intended Use 1.0 The KIMAX ™ Remote Viewing Station software and hardware (RVS) are intended ed to the Remote with and mamic digital images from radiographic and The KIMAX ™ Remote Viewstatic or dynamic digital images from radiographic and to allow physicians to view static or dynamic digital images from radiographic and to allow physicians to view station of dynamic digh-performance computer, other medical imaging equipment. The RVS includes a high-performance computer, other medical imaging equipment. The R V > includes a magn-pons intended to be used data storage devices, a high-resolution monitor and software to: l) data storage devices, a high-resolution monitor and Socware to: 1) in the clinical workspace of a practicing physician. The RVS includes software to: 1) Pressure of a the tha in the clinical workspace of a practicing physician: 2) allow physician to quickly accept AVI images or import other image formats; 2) allow physician to quickly accept AVI images or import other image formals, 27 and prightsess, apply filters to enhance locate and display images; 3) adjust contrast and brightness, apply filters to en locate and display images; 3) adjust contrast and offectures of interest, and the images, zoom in on selected teatures, pan to select reading of more of the rest annotate images; 4) print out selected images; and 5) create reports that include text and annotated images. Tämit le. A. yper Prescription Use K0/3098