SUNIPAN IMAGING SYSTEM & ACCESSORIES

{0}------------------------------------------------ # Kobo 149 FEB 3 2006 # Appendix V ## Summary Information DIGITAL.DOC {1}------------------------------------------------ | <b>Summary of Safety Information</b> | |-----------------------------------------------| | <b>Premarket Notification, Section 510(k)</b> | Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 Device Name: Sunipan Common Name(s): Digital imaging device Classification Name(s): Digital imaging device Manufacturer: Suni Medical Imaging, Inc. 6840 Via Del Oro, Suite 160 San Jose, CA 95119 408.227.6698 408.227.9949 Registration Number: 3003952803 #### Classification(s): #### Sec. 872.1800 Extraoral source x-ray system. (a) Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts. (b) Classification. Class II. | Device Class: | Class II for the requested indications | |-----------------------|----------------------------------------| | Classification Panel: | Dental Devices Panel | | Product Code(s): | 90-EHD | #### Equivalent Predicate Device: Suni Medical Imaging, Inc. believes that the Sunipan Imaging System is substantially equivalent to the following legally marketed Digital imaging device(s): - 1. K051664 Scan300fp/Retropan - 2. K043557 PC 1000 Equivalency can be seen with respect to place of manufacture, physical appearance, functional testing, material certification, instructions for use and indications for use. A feature comparison chart follows this section. #### Device Description: Axial rotation x-ray source (PC-1000). The PC-1000 panoramic X-ray machine portion of the Sunipan Imaging System generates the required ionizing radiation (x-rays) This unit is identical to the PC-1000 model supplied directly by Panoramic Corporation for use with standard x-ray film. The Sunipan Imaging System combines this base x-ray unit with an available aftermarket digital imaging sensor, creating a filmless digital imaging system. Digital Image Sensor (Scan300fp/Retropan) is a high speed x-ray camera tailored for dental panographic applications. Originally designed and cleared for retro-conversion of existing standard panographic x-ray units. The sensor system utilizes direct conversion technology which offers a number of benefits over CCD technology. The images obtained may be reviewed and adjusted after exposure to focus on different layers or areas of clinical it rest. {2}------------------------------------------------ The sensor utilizes Ajat software . Accessories: 1. Disposable Mouth Pieces. 2. Positioning Aids. #### Indications for Use: For diagnostic radiographic use in dental, oral surgery, and orthodontic practices Company Contact: Mr. F. A. Bettencourt Suni Medical Imaging, Inc. 6840 Via Del Oro, Suite 160 San Jose, CA 95119 408.227.6698 408.227.9949 Submission Correspondent: Mr. F. A. Bettencourt Suni Medical Imaging, Inc. 6840 Via Del Oro, Suite 160 San Jose, CA 95119 408.227.6698 408.227.9949 #### DIGITAL.DOC {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in a simple, abstract style. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Suni Medical Imaging, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131 Re: K060149 Trade/Device Name: SuniPan Imaging Systems & Accessories Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 19, 2005 Received: January 20, 2005 Dear Mr. Christensen: 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. FEB 3 2006 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yours ough finding of substantial equivalence of your device to a legally prematice notification: "Thesalts 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 n you desire speome at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, product not regaration on your responsibilities under the Act from the 807.77). " Ou may oount ourers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.litml. Sincerely yours, Nancy C. Bigdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page _________________________________________________________________________________________________________________________________________________________________________ 510(k) Number : // 06 0149 SuniPan Imaging System & Accessories Device Name(s): ### Indications for Use Statement(s): For diagnostic radiographic use in dental, oral surgery, and orthodontic practices. Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Usc PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Segerson (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K060149 (Per 21 CFR 801.109) (Optional format 1-2-96)