CRANEX TOME CEPH, OR CRANEX TOME

{0}------------------------------------------------ MAR 27 1998 # 510 (k) Summary Statement for the Soredex Cranex Tome Tomographic, Radiographic System #### I General Information | Submitter: | Orion Corporation Soredex | |------------|---------------------------| | | Nilsiänkatu 10-14 | | | FIN 00510, Helsinki | | | Finland | Telephone: + 358-9-3937402 Fax: + 358-9-7015261 Contact Person: Kai Lanér, Vice President Summary Preparation Date: December 19, 1997 # Names Proprietary Name: Cranex Tome or Cranex Tome Ceph Common or Usual Name: Tomographic X-ray system Classification Name: System, Tomographic, Radiographic 90 IZF # III Substantial Equivalent Devices Scanora (K884650) marketed by Orion Corporation Soredex, Tomographic functions Oralix Pan DC III Ceph (or Cranex 3 Ceph) (K880982) marketed by Orion Corporation Soredex , cephalometric functions {1}------------------------------------------------ # IV Product Description Cranex Tome Ceph is a high frequency Tomographic, Radiographic system capable of producing dental panoramic and tomographic images, TMJ (TemporoMandibular Joint) tomographic images and cephalometric images. It is available in two models with (Cranex Tome Ceph) and without (Cranex Tome) the cephalometric option. The Cranex TOME uses the principle of autotomography with a spiral blurring movement. This movement, which is similar to the movement used by the Soredex SCANORA®, is achieved by tilting and rotating the C-arm at the same time. The Cranex Tome comprises of - moving column - C-arm - An adjustable two-position chin support is used to carry out all exposure procedures. - Four-point head support and bite-block system - A large adjustable mirror - The patient positioning lights - control panel - graphical display - wide range of x-ray programs for mandible, maxilla, temporomandibular joint, sinus, and cephalometric exposures. - high-frequency generator -15x30 cm panoramic cassette for paroramic and tomographic imaging And the following with the cephalometric unit - Soft tissue filter adjustment with LED positioning indicators - selectable magnification ratio and a rotatable head support with positioning stops every 45 degrees. -The system software makes it impossible to take an exposure if the cephalometric cassette is the wrong size or incorrectly positioned. -Accepts 18x24, 8"x10" or 24x30 cm cephalometric cassettes - The cephalometric arm can be mounted on either the left- or the right-hand side of the unit -An cephalometric kit is available so that Cranex TOME can be upgraded to a Cranex TOME Ceph . #### V Inteded Use of the Device The Cranex Tome Ceph is intended for producing x-ray images of dentistry, TMJ and skull. The Cranex Tome is intended for producing x-ray images of dentistry and TMI. {2}------------------------------------------------ #### VI Indications for Use/Rationale for Substantial Equivalence Cranex Tome Ceph, Tomographic x-ray system is used as an extra-oral source for x-rays in dental radiography. It has similar instructions for use and installation, used materials, design, mode of x-ray generation (DC), operational and functional features as the substantial equivalent devices. It does not have all the different imaging programs of Scanora , however a substantial portion of those. Patient supporting, imaging programs and technique factor selection in cephalometric imaging is similar to Oralix Pan DC III Ceph (or Cranex 3 Ceph). # VII Summary of technological charasteristics Cranex Tome Ceph is - a high-frequency DC X-ray equipment - imaging programs for panoramic and tomographic examinations of the dentistry - imaging programs for tomographic examinations of the TMJ - imaging programs for cephalometric examinations of the skull. #### VIII Safety and Effectiveness Information Safety and effectiveness is demonstrated by: - clinical tests - software verification, validation and certification procedures - risk analysis - risk management file All the above items and evaluations lead to the conclution that Cranex Tome and Cranex Tome Ceph are safe and effective when the unit is used as labeled. #### IX Conclution Crane Tome Ceph Tomographic, Radiographic system is substantially equivalent to the predicate devices : Scanora and Oralix DC III Ceph (or Cranex 3 Ceph). The unit has similar design .operational and functional features as the current marketed predicative devices. The device has been shown to be safe and effective when it is used as labelled. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 27 1998 Re: Kai Laner V.P. Orion Corporation Soredex P.O. Box 79 FIN-00511 Helsinki Finland K974877 Cranex Tome Ceph, or Cranex Tome . Dated: December 19, 1998 Received: December 29, 1998 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD Dear Mr. Laner: We have reviewed your Section 510(x) 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 disgnostic 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.ida.gov/odrh/dsmaldsmamain.html". Sincerely yours, Kilian Yin Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: This image shows a document page. The page is labeled as "Page 1 of 1". The document includes the text "FDA/CDRH/ODE/DMC" and the date "2 FEB 93 16 23". K974877 510 (k) NUMBER : CRANEX TOME CEPH, or CRANEX TOME DEVICE NAME : INDICATIONS FOR USE : Tomographic X-ray System, which is intended for diagnostic dental radiography at the dento-maxillofacial region and additionally cephalometry. The imaging methods are narrow beam radiography and spiral tomography and central projection cephalometry. The method of image reception is film / intensifying screens. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96) Elmer C. Anderson (Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number