VERAVIEWEPOCS

{0}------------------------------------------------ ## APR - 8 2008 # 510(k) SUMMARY J. Morita USA Inc.'s Veraviewepocs X220 # 1. Submitter Name and Address with Phone/Fax : Registration No. 2081055 Initial Distributor: J. Morita USA, Inc. 9 Mason Irvine, CA 92618 USA Telephone: 949-581-9600 Facsimile: 949-581-9688 Registration No. 3002807636 Manufacturer: J. MORITA MFG. CORP. 680 Higashihama Minami-cho Fushimi-ku, Kyoto Japan 612-8533 +81-75-611-2141 +81-75-605-2353 2. Contact Person Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331 3. Date summary prepared: December 14, 2007 4. Device Name: Trade or Proprietary Name: Veraviewepocs Model : X550 (with 6 versions: X550-3DA/3DB/3DC/ X550-2DA/2DB/2DC ) Common Name: Product Code : Classification Name: Dental Panoramic/Cephalometric X-ray System with CT Capability Extraoral Source dental X-ray System ( 21CFR872.1800 ) MUH 5. Substantial Equivalency is claimed against the following devices: Veraviewepocs VE (K030699) 3D Accu-I-tomo XYZ Slice View Tomograph (K052587) ProMax3D (K060328) {1}------------------------------------------------ #### escription of the device: viewepocs ( Model X550) is extraoral source Dental Panoramic X-ray unit with a affequency switching mode x-ray generator. In addition to panoramic exposure, the an also take scano-grams. Also cephalometric device is available that uses the cramic x-ray source. ther more a three dimensional Cone Beam Computed Tomography (CBCT) is also which uses cone shaped x-ray beam projected onto a flat panel detector. e main body of X550 includes a base, support column, lift, patient frame, movement and arm, and control box. The main body weighs approximately 184 kilograms and mensions of 235.5cm (height), 102 cm (width), and 133 cm (depth). movement arm, with a X-ray sensor unit on one side of the patient's head and an thead on the other hand, is rotated 180 degrees as an arm combined on movement The movement unit with a patient frame, mounted to the lift, moves up and down sally along support column. of the main body is performed by Control Panel and Control Box. Control 1) selects exposure program, 2) raises up or lower down the lift, 3) positioning ON and OFF, 4) has ready key. ontrol Box equips hand switch, emission button, emission light, ready light, main er switch, power light, and key switch. #### Intended Use X550 is used with the purpose to obtain dental x-ray panoramic tomography ares, optionally with Cephalometric radiography and with three dimensional cone computed Tomography, all of which are intended for dental radiographic nination and diagnosis of diseases of the teeth, jaw and oral structures. {2}------------------------------------------------ ### Safety and effectiveness of the device There are already two kinds of FDA- cleared devices in J. MORITA MFG. CORP. as follows in the Table below. | No. | Device | 510(k) number | Functions of the device | NOTE | |-----|----------------------|---------------|------------------------------------------------------------------------|------| | ① | Veraviewepochs<br>VE | K#030699 | Dental digital x-ray<br>panoramic<br>with cephalometric<br>radiography | 2D | | ② | 3D accu-i- tomo | K#052587 | Dental x-ray computed<br>tomography | 3D | The Veraviewepocs (Model X550) is essentially a slightly modified device of (1) by being added only with the computed tomography function of ②. The device of being addition the by reconstructing a three dimensional matrix of the examined wolume and producing two-dimensional views of this volume, displaying both two (2D) images or three dimensional (3D) images. So that, the X550 is not only an conventional extraoral source X-ray 2D imaging unit of digital panoramic/cephalometric used for dental radiographic examination and of dignosis of teeth, jaw, and oral structure , but also has and 3D imaging capability for Dento-maxillofacial. The device is operated and used by physicians, dentists and x-ray technologists. The deviloed below, the X550 has the same general intended use, similar principles of As desertood bolon, the 110 be has characteristics as those of both previously cleared operation, and simmar vesiment group E (K#030699) and 3D Accu-I-tomo (K#052587) . In addition, this sort of modification of adding 3D imaging capability over 2D imaging is completely identical to the case of the modification of Planmeca Oy's ProMax 3D (K#060328) under the reference of our 3D Accu-I-tomo (K#052587). Consequently, it is self-explanatorily evident that this X550 is substantially equivalent to Planmeca Oy's ProMax 3D (K#060328) in the sense of the same general intended use, similar principles of operation, and similar technological characteristics. | | Table-1 Comparison summary chart | | | |-------------------|----------------------------------|--------------------------|--------------------| | | This new submission | Predicate | Difference | | Name of the model | X550 | ProMax 3D | Different | | Manufacturer | J.MORITA MFD. CORP. | Planmeca Oy | Different | | Construction | Rotating arm and base | Rotating arm and base | Similar | | Image Receptor | Flat panel detector | Flat panel detector | Identical | | Performance spec. | International standards | International standards | Similar | | Mechanical | Morita made mechanism | Unknown mechanism | Presumably Similar | | Electrical | Morita made electric circuit | Unknown electric circuit | Presumably Similar | | Software | Morita made software | Unknown software | Different | | Testing | Mainly done by VDE | Unknown | Presumably Similar | Table.1 Comparison summary chart {3}------------------------------------------------ # Table-2 Comparison summary table FDA file reference number 510k number ; K060328 1. 1. 1. 1. 1. | Model name of Predicate Device | ProMax 3D | |--------------------------------------------------|--------------------| | 510(k) number of Predicate Device | K060328 | | TECHNOLOGICAL CHARACTERISTICS | Comparison result | | Indication for use | Identical | | Target population | Identical | | Design | Presumably similar | | Materials | Similar | | Performance | Similar | | Sterility | Similar | | Biocompatibility | Similar | | Mechanical safety | Similar | | Chemical safety | Identical | | Anatomical sites | Similar | | Human factors | Similar | | Energy used and/or delivered | Similar | | Compatibility with environment and other devices | Similar | | Where used | Identical | | Standards met | Identical | | Electrical safety | Similar | | Thermal safety | Identical | | Radiation safety | Identical | . The same of the comments of the comments of the comments of : {4}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 8 2008 J. Morita USA, Inc. c/o Keith A. Barritt Fish & Richardson P.C. 1425 K St. N.W. Suite 1100 WASHINGTON DC 20005 Re: K073696 Trade/Device Name: Veraviewepocs 2D/3D Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: March 4, 2008 Received: March 5, 2008 DEPARTMENT OF HEALTH & HUMAN SERVICES Dear Mr. Barritt: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device i 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. {5}------------------------------------------------ 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 that I Dr has mace a sud regulations administered by other Federal agencies. You must or any I vith 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 electronic product radiation control provisions (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 lottor will and would be of substantial equivalence of your device to a legally premated 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), please 11 you don't openter for Devices and Radiological Health's (CDRH's) Office of Compliance 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's (210) 11 Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division 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/cdrb/industry/support/index.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use K073696 510(K) Number : - unknown Device Name: Veraviewepocs 2D/3D Indications for Use: The Veraviewepocs is an extraoral source x ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM joints and skull including the ENT and dento maxillofacial areas, by exposing an X ray image receptor to ionizing radiation. The device uses cone shaped x ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals. Prescription Use (Part21CFR801 Subpart D) Over-The-Counter Use (Part21CFR807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation(ODE) Prescription Use (Part21CFR801.109) Over-The-Counter Use (Optional Format 1-2-96) Nairey C. Brogdon (Division Sign-Off) Or Division of Reproductive, Abdominal, and Radiological Devices.