CADI, VERSION 4

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized human figure with three wavy lines representing the body and head. The words "DEPARTMENT OF HEALTH" are arranged vertically along the left side of the logo, with the letters oriented to follow the curve of the logo. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 NOV 2 0 2006 Mr. Stephane Arsenault Official Correspondent Synca Marketing, Inc. 337 Marion Street Le Gardeur, Quebec, J5Z 4W8 CANADA Re: K062237 Trade/Device Name: CADI Version 4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 25, 2006 Received: October 26, 2006 Dear Mr. Arsenault: 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 cnactment 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. 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/0/Picture/10 description: The image is a circular seal or logo. The text "1906 - 2006" is at the top of the seal. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. There are four stars at the bottom of the seal. ag and Promoting Public 9 {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I cacial statutes and registerients, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI N Far 6077, adomig (21 CFR Part Paulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) This icael with anow you're ough times of substantial equivalence of your device to a legally premarket notification: "The Presults 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), please If you desire specific advise to your and of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 | |----------------|---------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (21 CF F r at 60 : 31). " v of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.litml. Sincerely yours, Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Section 4 Indications for Use Statement CADI is a dental imaging software for general dental and maxillo-facial diagnostic. It controls capture, display, treatment, analysis and saving of digital images from x-ray units, intraoral or extraoral dental camera, digital cameras, and images acquired by digitizing film with a scanner, in order to enable a dentist to diagnose the dental health of a patient. CADI is a modular software, meaning that it offers dentistry professionals the choice to activate specific modules, depending on the type of image sources they use. These modules are as follows: Digital x-ray module: This module features a 16-bit x-ray viewer and imaging tools used to enhance the image quality of x-rays taken by sensors or phosphor plate systems. Intraoral Camera Module: CADI automatically enhances images captured by intraoral cameras and sorts them by tooth number. Digital Camera Module: This module allows importing digital camera images, and sorts them in order in a patient file. Printouts are automatically sorted in AAO order, or any custom order. This module also crops and prints images. Cosmetic and Whitening Module: CADI simulates whitening results in minutes to help build an in-office program for patients. It also provides cosmetic makeover simulations using a library of natural smile images. Natural Smiles Library: Smiles library that sorts images in a logical order, including images for a range of ethnic backgrounds. Orthocephalometric Tracing (DFO) Module: CADI DFO uses point location tools and a tutor window to help achieve cephalometric tracings. It includes most current and popular tracing analysis, and allows the user to create his/her own analysis. CADI is a prescription use only product, intended to be used by dental professionals only. Stephane Arsenault October 25, 2006 Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductius Division of Reproductive, Abdon and Radiological Devi 510(k) Number Image /page/2/Picture/19 description: The image shows the word "SYNCA" in all capital letters. To the right of the word is a circular graphic with a solid black circle on top of a target-like design. The target design consists of three concentric circles, with the innermost circle being white and the other two being black. 337 Marion Street. Le Gardeur, QC, Canada, J5Z 4W8 1-800-667-9622 Fax : 1-800-554-1021 email : synca@synca.com