PANATOME

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Imaging Sciences International Inc. along with the date JUN 18 1999. The logo is a stylized "IS" in bold, black font. The text "IMAGING SCIENCES INTERNATIONAL INC." is printed in bold, black font to the right of the logo. K991518 1910 North Penn Road Hatfield, PA 19440 Phone (215) 997-5666 Fax (215) 997-5665, 5667 ## 510 (k) Summary ## Submitters Information Name: Address: Phone Number: Fax Number: Person To Contact: Imaging Sciences International Inc. 1910 North Penn Road Hatfield PA, 19440 215-997-5666 215-997-5665 April 16, 1999 Robert E. Hay Radiation Safety Officer Quality Management Representative Date Of Summary: Trade Name Of The Device: Common Or Usual Name: Classification Name: Panatome Tomographic X-Ray X-Ray, Tomographic {1}------------------------------------------------ Substantial Equivalence Claim: The Imaging Sciences International Inc. Panatome Tomographic X-Ray machine is substantially equivalent to the Imaging Sciences International Inc. CommCAT IS 2000 Tomographic X-Rav system. Description Of The Device: The Imaging Sciences International Inc. Panatome is a free standing Tomographic X-Ray machine that may also be affixed to the wall during installation for added stability. All of the Panatome functions such as kVcp, mA, exposure time and all motor functions are computer controlled. There is a touch screen monitor that will display the various technique factors. Intended Use Of The Device: The Imaging Sciences International Inc. Panatome Imaging system is a multifunction computer controlled Tomographic X-Ray device for taking radiographs of the head and neck region. This device has the ability to provide panoramic and pluridirectional Tomographic images. The operators manual describes the computerized operator interface for selecting and executing the various radiographic procedures. The panoramic function of this unit produces the same standard panoramic image as numerous other units in use for past several decades. The tomographic function is also similar to other units in use for past few decades, except it employs complex motion to produce tomographic slices as opposed to more commonly used linear motion. Slices produced by a complex tomographic motion are superior and more accurate as compared to linear slices. Complex motion has been used by a few other units in the recent past. Tomographic imaging is commonly used for TM Joint studies, mandible & maxilla for implant planning, sinuses, etc. Technological Characteristics Of The Device: The XR-910 technology is based on the Keystone X-Ray Intrex VSK, 510 (k) Number K931486. The basic power supply consists of a full wave bridge rectifier, so connected that it may be operated on either 120 VAC or 220 VAC. 50 - 60 Hz power lines. This accomplished by changing jumpers in the power supply. નું {2}------------------------------------------------ At the output of the bridge rectifier, two very high capacity 250V filter capacitors smooth the rectified power, which is then presented to a voltage requlator, consisting of five transistors, amplifiers and a reference diode. This regulator regulates the voltage applied to a four diode transistor inverter chopper. Another low voltage power supply, with its step down transformer, bridge rectifier, and associated filters, supply power to another regulator and a logic board, so connected as to control the technique factors and the "on - off" exposure of the X-Ray System. The inverter is supplied by a 20 KHz signal that is developed on the logic board. This 20KHz alternately turns on and off the inverter to chop the DC power that has been generated in the power supply. The 20KHz square wave is now transformed into 200 volt positive and negative pulses, this signal is then sent to the tubehead. In the tubehead the signal is supplied to a power output transformer, which raises the 200 volts to 6,000 volts. This 6,000 volts is now applied to a plus and minus multiplier PC boards. With its associated diodes and capacitors, the multiplier boards raise the 6,000 volt square wave to plus 35,000 and minus 35.000 volts. An X-Ray tube is placed between the two multiplier board outputs creating a potential across the X-Ray of 70,000 volts. The 20 KHz. 200 volt square wave may be adjusted upward and downward to create a kVp range from 50 kVp to 90 kVp in 1 kVp increments. The filament of the X-Ray tube is also heated by the 20 KHz signal taken directly from the oscillator on the logic board. A rheostat is placed in series with the filament transformer. so it may be shunted out for fast heating of the filament, and switched back in during the exposure. A voltage divider in the multiplier circuit of the tubehead allows the monitoring of the kVp. A current sample obtained from the primary of the power transformer allows the mA to be proportionately monitored within a 10% accuracy. Two timers are included on the Timer PC board. One of the timers delays the exposure turn on until the filament has reached sufficient operating temperature. The second timer times the length of the desired exposure. The exposure time is can be programmed from 0.01 to 4.0 seconds in increments of 0.01 seconds. The clock for these timers operates at 1,000 KHz. and is divided down on the logic PC board. {3}------------------------------------------------ In operation when, the exposure switch push button is depressed, the delay timer starts counting down a preprogrammed time that allows the filament to heat up to its proper temperature. When the delay timer has timed out the countdown of the exposure timer starts. At the end of the exposure, the exposure timer signals the inverter logic to cease operation, thereby shutting down both the high voltage anode and filament supplies, terminating the exposure. Assessment of Non-Clinical Performance: During the evaluation, the Panatome produced radiographs of a step wedge and a phantom that were comparable with the CommCAT IS 2000 and are adequate for their intended use. Conclusions of Non-Clinical Performance: The performance of the Imaging Sciences International Inc. Panatome during the non-clinical evaluation would indicate that the system is substantially equivalent mechanically, electrically and radiographically to the Imaging Sciences International Inc. CommCAT IS 2000. {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service JUN 18 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Robert E. Hay Radiation Safety Officer Imaging Sciences International, Inc. 1910 North Penn Road Hatfield, PA 19440 Re: K991518 PanaTome Tomographic X-ray Machine Dated: May 21, 1999 Received: May 24, 1999 Regulatory Class: II 21 CFR 872.1800/Procode: 90 EHD Dear Mr. Hay: 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 redassified 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 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 regulatory 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.qov/cdrh/dsmaldsmamain.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 {5}------------------------------------------------ ## Panatome X-Ray Unit Indications for Use 510(k) Number (if known): * Device Name: he Imaging Sciences International Inc. Panatome Imaging system is a Indications Holly Coloneoo Intornational Tomographic X-Ray device for taking radiographs of the head and neck region. This device has the ability to produce panoramic and pluridirectional Tomographic images. The operator's manual describes the computerized operator interface for selecting and executing the various radiographic procedures. > The panoramic function of this unit produces the same standard panoramic image as numerous other units in use for past several decades. > The tomographic function is also similar to other units in use for past fel decades, except it employs complex motion to produce tomographic slice as opposed to more commonly used linear motion. Slices produced by complex tomographic motion are superior and more accurate as compare to linear slices. Complex motion has been used by a few other units in the recent past. > Tomographic imaging is commonly used for TM Joint studies, mandible \ maxilla for implant planning, sinuses, etc. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel h. Segner (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number K991519 Prescription Use (Per 21 CFR 801.109) √ OR Over-The-Counter Use (Optional Format 1-2-96) 5-1