PREXION3D ECLIPSE

{0}------------------------------------------------ 12122199 Image /page/0/Picture/1 description: The image shows the text "Touching your heart" above the word "YOSHIDA". To the left of the word "YOSHIDA" is a diamond shape with the letters "UY" inside. The text is in black and the background is white. ### Section 6- 510(k) Summary ## APR 1 8 2013 a. Owner/Company name, address THE YOSHIDA DENTAL MFG. CO., LTD. 1-3-6, Kotobashi, Sumida-ku Tokyo 130-8516, Japan Michizo Yamanaka President · Contact person Hidenori Watanabe Regulatory Affairs Phone: 011-81-3-3631-2165 Fax: 011-81- 3-3633-9420 Email: hi-watanabe@yoshida-net.co.jp ### b. Contact/Application Correspondent Toshimitsu Murakami General Manager, Product Development Dept. PreXion Co., Ltd. 1-14-1 Kandasuda-cho. Funai Tokyo Technology Center Building 10F, Chiyoda-ku, Tokyo, 101-0041, Japan 011-81-3-5297-2822 Phone: 011-81-3-5297-7552 Fax: Email: toshim@prexion.co.jp #### Date prepared c. July 20, 2012 ### d. Name of device Trade Name: PREXION3D ECLIPSE Common Name: Computed tomography x-ray system Classification Name: X-ray, tomography, computed, dental Classification Regulation: 21 CFR 892.1750 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Yoshida. The text "Touching your heart" is at the top of the logo. The logo also includes a diamond shape with the letters "UY" inside of it. Image /page/1/Picture/1 description: The image shows four black silhouettes against a white background. The first silhouette appears to be a dentist's chair with an overhead light. The second silhouette shows two baseball bats. The third silhouette shows a drill press. The fourth silhouette shows a medical device. ### e. Predicate devices The PREXION3D ECLIPSE is substantially equivalent to the following legally marketed device: | 510(k) Number | Trade name | Product code | |---------------|-------------|--------------| | K063622 | FINECUBE | OAS | | K103659 | CS 9300 | OAS | | K111231 | PANOURA 18S | MUH | The predicate devices are hereinafter called "the FINECUBE (k063622)", "CS 9300 (K103659), or "the PANOURA 18S (k111231)" in this application. #### f. Description of the device The PREXION3D ECLIPSE consists of scanner and two software including Console software, and Viewer software used for the Image Analysis System and Data processing. A qualified computer named Console computer is distributed with the PREXION3D ECLIPSE. The PREXION3D ECLIPSE uses the Image Analysis System and the processed data acquired by the scanner to analyze 2D and 3D images, perform image edition, such as creating cross-section views, and output results to a printer or other output device. During scanning, X-rays are generated from the X-ray tube head mounted in the arm of the scanner and the X-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware and the Console software installed on the qualified computer. The detected X-ray absorption data is processed by the Console software and viewer software on each computer to reconstruct images. Scanning is performed using X-ray penetration signals of a patient taken from multiple directions to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial region for the diagnosis of hard tissue The PREXION3D ECLIPSE performs three types of scanning including CT scan generating two (2) or three (3) dimensional images, Panoramic scan generating two (2) dimensional images and Cephalometric radiography generating a plain radiographic image. #### Indications for Use g. PREXION3D ECLIPSE is intended to produce two-dimensional digital panoramic and cephalometric images, and three-dimensional digital X-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support. ### h. Statement of substantial equivalence The PREXION3D ECLIPSE was developed from the FINECUBE (k063622) by adding panoramic scan function and cephalometric radiography. Following characteristics of the PREXION3D ECLIPSE are identical or similar to those of the FINECUBE (k063622); - X-ray Generation features including tube voltage, tube current, and focal Spot Size K122199 510(k) Summary PAGE 2 OF 7 YOSHIDA DENTAL MFG CO., LTD. K122199 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image contains the text "Touching your heart" in a stylized font at the top. Below this text is a logo consisting of a diamond shape with the letters "UY" inside. To the right of the logo is the word "YOSHIDA" in a bold, textured font. The overall design appears to be a brand or company logo with a tagline. Image /page/2/Picture/1 description: The image contains four black silhouette images of different objects. The first object appears to be a person sitting at a desk with a lamp. The second object appears to be two baseball bats. The third object appears to be a drill press. The fourth object appears to be a portable air compressor. - X-ray image capturing features for CT scan including type of detector, pixel size, and pixel number The difference of the PREXION3D ECLIPSE from the FINECUBE (k063622) is addition of panoramic scanning function and cephalometric radiography. The panoramic scanning function of the PREXION3D ECLIPSE is similar to that of CS 9300 (k103659). The PREXION3D ECLIPSE has the similar characteristics to CS 9300 (k103659) regarding X-ray generation features including tube current and focal spot size, X-ray image capturing features including type of detector and pixel numbers. The intended use of the PREXION3D ECLIPSE is identical to part of intended use of the CS 9300 (k103659), and similar to the intended use of the FINECUBE (k063622). . The fundamental technology of cephalometric radiography of the PREXION3D ECLIPSE is identical to that of the PANOURA 18S (k111231). The PREXION3D ECLIPSE has the similar characteristic regarding X-ray generation features including tube current and focal spot size. The X-ray image capturing device of the PREXION3D ECUPSE is different from that of the PANOURA 18S (k111231). In order to ensure same performance characteristics as predicate devices, software validation, performance testing, and risk analysis were performed. Such test results and risk analysis indicate that the PREXION3D ECLIPSE meets the requirements of the recognized consensus or voluntary standard. Based on the information presented above we conclude that the PREXION3D ECLIPSE is substantially equivalent to the predicate devices and does not raise any new questions regarding safety or effectiveness. #### i. Comparison table Table 6-1 compares the characteristics between the PREXION3D ECLIPSE and the predicates. K122199 510(k) Summary PAGE 3 OF 7 {3}------------------------------------------------ | fouching your heart | and the first of the first of the first of the first of the first of the first of the first for<br>1<br>Charle<br>- Car<br>1 | Table 6-1. Comparison Table | |---------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------| |---------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Image: coil | |-------------| | Image: boat | | Image: arms | | Image: map | | Item | PREXION3D ECLIPSE | FINECUBE (k063622) | CS 9300 (k103659) | PANOURA 18S(k111231) | | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------| | Indications for Use | PREXION3D ECLIPSE is intended to produce two-dimensional panoramic and cephalometric images, and three-dimensional digital X-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support. | FINECUBE is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists. | The CS 9300 and CS 9300C are systems intended to produce two-dimensional and three-dimensional digital x-ray images of the dento-maxillo-facial, and ENT (Ear, Nose and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. In addition, the CS 9300C is intended to produce cephalometric images. This includes imaging the hand and wrist to obtain the carpus image for growth and maturity assessment. | The Panoura 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The device must only be operated and used by dentists and other legally qualified professionals. | | | X ray Generation Device | Tube Voltage | 50 - 90kV | 90kV | 60 - 90kV | 58 - 82kV | | | Tube Current | 1 - 4mA | 4mA | 2 - 15mA | 2.0 - 10mA | | | Focal Spot Size | 0.2mm | 0.2mm | 0.7mm | 0.5mm | | | Detector | FPD | FPD | FPD (TFT) | CMOS | | X ray image capturing device | Pixel size | 200µm (CT)<br>100µm (Panoramic)<br>54µm (Ceph) | 200µm | | 100 x 100 μm | | | Pixel number | 640 x 656 (CT)<br>80 x 1312 (Panoramic)<br>128 x4080 (Ceph) | 608 x 616 | 64 x 1536 (Panoramic) | 64 x 1536 (Panoramic)<br>64 x 2266 (Ceph) | YOSHIDA DENTAL MFG CO., LTD. K122199 K-122-199 Summary PAGE 4 OF 7 {4}------------------------------------------------ | 1<br>-<br>12 | |--------------| | Item | | PREXION3D ECLIPSE | FINECUBE (k063622) | CS 9300 (k103659). | PANOURA 18S(k111231) | |-------------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------------------| | Size of Area<br>receiving<br>X-ray. | | 128.1mm x 131.3mm (CT)<br>8mm x 131.3mm<br>(Panoramic)<br>6.9mm x 312mm (Ceph) | 121.6mm x 123.2mm | 5 x 149 mm max<br>(Panoramic) | 5 mm x 149 mm max<br>(Panoramic)<br>6.4mm x 226.6mm (Ceph) | | Number of<br>Bit | | 14bits (CT, Panoramic)<br>16bits (Ceph) | 12bits | 14 bits | 14 bits | | SID/SOD | | 620 mm / 400 mm (CT,<br>Panoramic)<br>1650 mm/1500 mm (Ceph) | 700mm/322mm(Magnificati<br>on imaging)<br>700mm/468mm(Wide area<br>imaging) | 615mm (SID) | 615mm (Panoramic)<br>1650 mm / 1500 mm (Ceph) | | Scanner | Dimension<br>(W×D×H) | 1245mm×1288mm×2045mm<br>(CT. pan)<br>1805mm×1288mm×2045mm<br>(Ceph) | 1170mm×1530mm×1930mm | 1158mm×1595mm×2378mm | 1158mm×1595mm×2378mm<br>(Pan)<br>1835mm x1192mm x<br>2378mm (Ceph) | | | Weight | 260kg (CT, Pan)<br>300kg(Ceph) | 390kg | 160kg (CT, Panorama)<br>190Kg (Ceph) | 160kg (Panoramic)<br>215kg (Ceph) | | | Imaging<br>mode | CT scan, Panoramic scan,<br>Cephalometric radiography | CT Scan | CT Scan, Panoramic Scan,<br>Cephalometric radiography | Panoramic Scan,<br>Cephalometric radiography | | Panoramic<br>scan<br>Performance | Scan time | Standard mode: 16 sec | - | 4 - 16 sec | 4- 16 sec | | Cephalometric<br>radiography | Scan time | LA, PA, Carpus:<br>8, 10, 12, 15sec | - | 0.1-3.2 sec | LA, PA, Carpus: 8, 10 sec | | CT scan<br>Performance | Scan time | Light mode: 8.7sec<br>High Definition mode: 8.7<br>sec<br>Ultra High Definition mode:<br>17.4 sec<br>Wide mode: 9.1 sec x 2 | 19sec. (Standard mode)<br>37sec. (High density mode) | 12 - 20 sec<br>28 sec | | | | FOV<br>(voxel size) | Light mode, High<br>Definition mode, Ultra High<br>Definition mode: Diameter | Wide area imaging<br>φ82.0mm H75.1mm | φ170mm/H135mm<br>(0.090mm -0.500mm) | | . YOSHIDA DENTAL MFG CO., LTD. K122199 K122199 510(k) Summary PAGE 5 OF 7 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the text "Touching your heart" in a cursive font. Below this text is a diamond shape with the letters "UV" inside. To the right of the diamond shape is the word "YOSHIDA" in a bold, vertical font. The text and shapes are all in black and white. Image /page/5/Picture/1 description: The image shows four different objects in a vertical arrangement. The first object appears to be a tool with a handle and a pointed end. The second object looks like a piece of machinery with multiple components. The third object consists of two elongated shapes, possibly rods or tubes. The fourth object is an abstract shape with some linear elements attached to a larger, irregular form. | Item | PREXION3D ECLIPSE | FINECUBE (k063622) | CS 9300 (k103659) | PANOURA 18S(k111231) | |------|--------------------------------------|-------------------------------------------------|--------------------------------------------|----------------------| | | Wide mode: Diameter<br>113mm, H 72mm | Magnification imaging<br>$\phi$ 56.5mm, H51.7mm | $\phi$ 170mm/H110mm<br>(0.090mm - 0.500mm) | - | | | | - | $\phi$ 170mm/H60mm<br>(0.090mm - 0.500mm) | - | | | | - | $\phi$ 100mm/H100mm<br>(0.090mm - 0.500mm) | - | | | | - | $\phi$ 80mm/H80mm<br>(0.090mm - 0.500mm) | - | | | | | $\phi$ 100mm/H50mm<br>(0.090mm - 0.500mm) | - | | | | | $\phi$ 50mm/H50mm<br>(0.090mm - 0.500mm) | - | YOSHIDA DENTAL MFG CO., LTD. K122199 K122-199 510(k) Summary PAGE 6 OF 7 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "YOSHIDA" in a bold, textured font, with the tagline "Touching your heart" above it. To the left of the word is a diamond shape with the letters "UY" inside. The text and logo appear to be part of a brand or company identity. Image /page/6/Picture/1 description: The image shows four different silhouettes of machines. The first machine has a rounded base with a mechanical arm extending from the top. The second image shows two cylindrical objects that appear to be baseball bats. The third and fourth images show machines with vertical columns and mechanical arms extending from the top. #### i. Risk Analysis The PREXION3D ECLIPSE was evaluated in accordance with ISO14971:2007. The risk management of the device was deemed satisfactory. ### k. Bench Testing THE YOSHIDA DENTAL MFG. Co., LTD has performed bench tests to ensure safety and effectiveness as follows: ### 1. Laser Safety The laser system of the PREXION3D ECLIPSE is identical to that of the PANOURA 18S (KI11231). Therefore, the test report for IEC 60825-1 for the PANOURA 18S (K111231) is used as the test report for the PREXION3D ECLIPSE. ### 2. Modulation-Transfer Function In order to evaluate the spatial resolution of the PREXION3D ECLIPSE, we measured the MTF in accordance with IEC 61223-3-5. The spatial resolution of all scan modes met the acceptance criteria. ### 3. Artifact Analysis In order to evaluate the artifact of the image of the PREXION3D ECLIPSE, the images of all scan mode of the PREXION3D ECLIPSE were compared to those of the FINECUBE (K063622). There was no difference of pattern and strength of the metal artifact between the PREXION3D ECLIPSE and the FINECUBE(K063622). The software of the PREXION3D ECLIPSE has been validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." EMC, Electric safety, and X-ray radiation safety are confirmed in accordance with IEC60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28. and IEC 60601-2-32. #### 1. Conclusion The PREXION3D ECLIPSE has similar intended use and technical characteristics to the predicate devices including the FINECUBE (k063622), CS 9300 (k103659), and the PANOURA 18S (K111231). A number of test results and risk analysis indicate that the PREXION3D ECLIPSE meets the requirements of the recognized consensus or voluntary standard. Based on those information, we conclude that the PREXION3D ECLIPSE is substantially equivalent to the predicate devices and does not raise any new questions regarding safety or effectiveness. K122199 510(k) Summary {7}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol. Public Health Service Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 18, 2013 The Yoshida Dental Mfg. Co., LTD. % Mr. Toshimitsu Murakami General Manager, Product Development Dept. PreXion Co., Ltd. 1-14-1 Kandasuda-cho Funai Tokyo Technology Center Building 10F Chiyoda-ku, Tokyo, 101-0041 JAPAN Re: K122199 Trade Name: PreXion 3D Eclipse Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: II Product Code: OAS Dated: March 29, 2013 Received: April 3, 2013 Dear Mr. Murakami: 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {8}------------------------------------------------ Page 2 - Mr. Murakami 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Ramingh. Mendo Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ # Indications for Use K122199 510(k) Number (if known): . Device Name: PreXion 3D Eclipse Indications for Use: PREXION3D ECLIPSE is intended to produce two-dimensional digital panoramic and cephalometric images, and three-dimensional digital x-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Flaming H. Diego (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health K122199 510(k) Page 1 of 1