PEFECT SHOT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Roger C. Claar, PhD. Vice President of Operations & Regulatory Affairs International Imaging Electronics --881 Remington Boulevard Bolingbrook, Illinois 60440-4932 JUL - 3 1997 Re : K972019 Trade Name: Perfect Shot Regulatory Class: I Product Code: EIA Dated: May 29, 1997 Received: June 1, 1997 Dear Dr. Claar: 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 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, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbrandinq 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਮੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {1}------------------------------------------------ Page 2 - Dr. Claar through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known): K972019 Device Name: Perfect Shot Intra-Oral Camera Indications For Use: The Perfect Shot Intra-Oral Camera is to be used by medical practitioners, usually dental hygienists, assistants or dentlats, to view the mouth of patients. It can explore the entire mouth and examine teeth or gum tissue for diagnostic purposes. It is distributed through dealers to medical practitioners. The Perfect Shot is wireless, unlike other similar devices, allowing more freedom of movement by the user. It also contains voice activated instructions which enable the user to "freeze" a view on the monitor or take a picture and print) of the area being examined for reference at a later date by simply using voice instructions. The product is designed to transmit a RF (radio frequency) signal to a receiver. This product can and will be used both intra and extra orally, which will allow a dentist to examine and display to the patient problem areas of concern or treatment that is required. The resolution capabilities of the CCD (Charge Coupled Device) is 640-480 lines. The picture is transmitted to a monitor in the examination area for the patient to view , allowing the patient a better understanding of a potential problem and a better explanation of the prescribed solution. Pictures that are captured may be printed for further review or for patient files. The Perfect Shot may also be attached to computers for digital storage or transmission to other computers. ## (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 Dental, Infection Control, and General Hospital Devices | | | 510(k) Number | K972019 | | Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:inline-block; vertical-align:top;">/</div> | |------------------------------------------|----------------------------------------------------------------| |------------------------------------------|----------------------------------------------------------------| OR | Over-The-Counter Use | ____________________ | |----------------------|--------------------------| | | (Optional Format 1-2-96) |