PreXion3D Explorer PRO

{0}------------------------------------------------ July 22, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The Department of Health & Human Services seal is a stylized representation of a human figure. The FDA acronym is in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font. PreXion Corporation % Hiroaki Takahashi General Manager 1-14-1. Kandasuda-cho Chiyoda-ku, Tokyo 101-0041 JAPAN # Re: K221525 Trade/Device Name: PreXion3D Explorer PRO Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: May 24, 2022 Received: May 26, 2022 ## Dear Hiroaki Takahashi: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221525 Device Name PreXion3D Explorer PRO #### Indications for Use (Describe) PreXion3D Explorer PRO is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the logo for PreXion. The logo features the word "PreXion" in a stylized font, with the "IT" in the tagline "make IT visible" in blue. Above the text is a blue and white swoosh design, adding a modern and dynamic element to the logo. # 510(k) Summary # PreXion3D Explorer PRO # K221525 # 1. Submission Sponsor PreXion Corporation 1-14-1, Kandasuda-cho, Chiyoda-ku, Tokyo 101-0041 Japan Hiroaki Takahashi General Manager, Quality Assurance & Regulatory Division Email: px-ra@prexion.co.jp Office number: +81-3-5297-7551 # 2. Submission Correspondent Same as above # 3. Date Prepared May 24th, 2022 ## 4. Device Identification Trade/Proprietary Name: PreXion3D Explorer PRO - Common/Usual Name: OAS: Computed Tomography X-Ray System - Regulation Number: OAS: 21 CFR 892.1750 - Product Code: OAS - Device Class: Class II - Classification Panel: Radiology {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Prexion. The word "Prexion" is written in a light gray, italicized font. Below the word "Prexion" is the phrase "make IT visible" in a smaller font, with the "IT" in blue. Above and to the right of the word "Prexion" is a blue swoosh design. # 5. Legally Marketed Predicate Device(s) Predicate Device: K203784, PreXion3D Explorer PRO (Model: P03A), PreXion Corporation #### 6. Indication for Use Statement PreXion3D Explorer PRO is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old. #### 7. Device Description PreXion3D Explorer PRO consists of a scanner, which is used for generating X-ray and detecting image data, and a console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explore Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating crosssection diagram, etc.), and output the image to a printer. X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, Panoramic scan) and Cephalometric Scan. The operating principle of the device is as follows. <X-ray generation principle> X-rays are generated by the conversion of electron kinetic energy. Part of the kinetic energy which is generated when electrons moving at high speed are decelerated inside matter becomes the conversion source. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for PreXion. The logo features the word "PreXion" in a light gray, elegant font. Below the name is the tagline "make IT visible" in a smaller, bolder font, with the "IT" in blue. Above and to the right of the name is a stylized graphic of two curved shapes, one in a light gray and the other in a gradient of light to dark blue, creating a sense of depth and movement. Use a high-voltage transformer to boost the commercial voltage (100 to 240 V) to direct current high voltage (several tens of kV) and apply it to the X-ray tube to accelerate the X-ray tube's thermal electrons, and then the X-ray will be generated. The change in the voltage (tube voltage) and current (tube current) applied to the X-ray tube brings the following features. - The higher the X-ray tube voltage is, the greater the penetration strength of X-rays is. - The higher the current (tube current) is, the more the X-ray dose is. With the consideration of the above features, X-ray devices are designed to be able to control the X-ray dose and strength according to the intended use. <CT Scan principle and Panoramic Scan principle> X-ray photography is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan) and the tomographic image (CT scan, Panoramic scan). । Cephalometric Exposure Based on cephalometric radiography, a plain radiographic image of the properly positioned "patient's head" between X-ray generator and flat panel detector with stable magnification ratio, can be acquired. Also, the image of "patient's hand" can be obtained. ## <Software> PreXion3D Explorer PRO consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explorer PRO Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer. X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, Panoramic scan) and Cephalometric Scan. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for PreXion. The logo features the word "PreXion" in a stylized font, with the "IT" in the tagline "make IT visible" highlighted in blue. Above the text is a swooping, abstract graphic in shades of blue and gray, adding a modern and dynamic element to the overall design. For CT and Panoramic scan, the detected data is reconstructed using filtered-back-projection method. In the case of Cephalometric scan, the acquired 2D data is output as it is. The software is unchanged from the predicates in terms of function. - Software Level of Concern - The software level of concern for the PreXion3D Explorer PRO is Moderate. The rationale is as follows: Even prior to mitigation of hazards, there is no risk of serious injury or death associated with this software. Excessive X-ray irradiation can be considered as a risk of serious injury, but it is limited in scope by a hardware timer. A hardware activated buzzer indicating exposure and an emergency switch are also provided. As such, there is a risk of injury associated with the software, but not serious injury. # 8. Substantial Equivalence Discussion The following table compares the PreXion3D Explorer PRO to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device. | | Subject Device | Predicate Device | | | |-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------| | Manufacturer | PreXion Corporation | PreXion Corporation | Comparison<br>to Predicate | | | Trade Name | PreXion3D Explorer<br>PRO | PreXion3D Explorer<br>PRO | | | | Model Name | P03B | P03A | N/A | | | 510(k) Number | K221525 | K203784 | N/A | | | Product Code | OAS | OAS | Same | | | Regulation Number | OAS: 21 CFR 892.1750 | OAS: 21 CFR 892.1750 | Same | | | Regulation Name | OAS: Computed<br>tomography x-ray<br>system | OAS: Computed<br>tomography x-ray<br>system | Same | | | Device Classification<br>Name | X-Ray, Tomography,<br>Computed, Dental | X-Ray, Tomography,<br>Computed, Dental | Same | | | PreXion3D Explorer PRO | | | | | | Indications for use: | PreXion3D Explorer PRO<br>is intended to produce<br>two dimensional digital<br>panoramic and<br>cephalometric images,<br>and three-dimensional<br>digital x-ray images of<br>the maxillofacial, and<br>ENT (Ear, Nose and<br>Throat) and neck region<br>at the direction of<br>healthcare professionals<br>as diagnostic support for<br>adult and pediatric<br>patients.<br>Cephalometric imaging<br>also includes the hand<br>and wrist to obtain<br>carpus images for<br>growth and maturity<br>assessment.<br>This device is not<br>intended for use on<br>patients less than<br>approximately 21 kg (46<br>lb) in weight and 113 cm<br>(44.5 in) in height; these<br>height and weight<br>measurements<br>approximately<br>correspond to that of an<br>average 5 year old. | PreXion3D Explorer PRO<br>is intended to produce<br>two dimensional digital<br>panoramic and<br>cephalometric images,<br>and three-dimensional<br>digital x-ray images of<br>the maxillofacial, and<br>ENT (Ear, Nose and<br>Throat) and neck region<br>at the direction of<br>healthcare professionals<br>as diagnostic support for<br>adult and pediatric<br>patients.<br>Cephalometric imaging<br>also includes the hand<br>and wrist to obtain<br>carpus images for<br>growth and maturity<br>assessment.<br>This device is not<br>intended for use on<br>patients less than<br>approximately 21 kg (46<br>lb) in weight and 113 cm<br>(44.5 in) in height; these<br>height and weight<br>measurements<br>approximately<br>correspond to that of an<br>average 5 year old. | Same | | | Patient/User<br>Characteristics | | | | | | Target Population | Children aged 6 (except<br>infants) to elderly | Children aged 6 (except<br>infants) to elderly | Same | | | Anatomical Site | The dental, oral,<br>maxillofacial region<br>ENT (Ear, Nose and<br>Throat) and neck region | The dental, oral,<br>maxillofacial region<br>ENT (Ear, Nose and<br>Throat) and neck region | Same | | | Users | Health care<br>professionals | Health care<br>professionals | Same | | | Technological<br>Characteristics and<br>Performance | | | | | | Patient Contact<br>Material | CHIN REST:<br>polycarbonate<br>Forehead Holder:<br>silicone rubber<br>HANDLE GRIP:<br>silicone rubber | CHIN REST:<br>polycarbonate<br>Forehead Holder:<br>silicone rubber<br>HANDLE GRIP:<br>silicone rubber | Same | | | Sterility | Non-sterile | Non-sterile | Same | | | X-ray<br>Generati<br>on<br>Device | Tube<br>Voltage | 90-110KV | 90-110KV | Same | | | Pulse<br>Exposure<br>function | Yes | Yes | Same | | | Tube<br>Current | 1-5.3mA | 1-5.3mA | Same | | | Focal Spot<br>Size | 0.3mm x 0.3mm | 0.3mm x 0.3mm | Same | | Collimator Size | | CT scan (Face) /CT-<br>Panorama Scan (Face):<br>33.6mm x 27mm<br>CT scan (Arch): 20.6mm<br>x 20.8mm<br>CT scan (Full): 23mm x<br>27mm<br>CT scan (Teeth) :<br>10.5mm x 10.2mm<br>Panoramic Scan: 1mm x<br>24.2mm<br>Cephalometric Exposure:<br>22.0mm x 17.6mm | CT scan (Face) /CT-<br>Panorama Scan (Face):<br>Same<br>CT scan (Arch): Same<br>CT scan (Full): Same<br>CT scan (Teeth): Same<br>Panoramic Scan: Same<br>Cephalometric Exposure:<br>23.6mm x 18.7mm | Similar<br>(Same except<br>for<br>Cephalometric<br>Exposure) | | | Detector | FPD (TFT) | FPD (TFT) | Same | | X-ray<br>Image<br>Capturin<br>g Device | Pixel Size | 248 µm x248µm (With<br>binning)<br>(CT, CT-Panoramic,<br>Panoramic)<br>124 µm x124µm<br>(Without binning)<br>(CT, CT-Panoramic,<br>Panoramic, Ceph) | 248 µm x248µm (With<br>binning)<br>(CT, CT-Panoramic,<br>Panoramic)<br>124 µm x124µm<br>(Without binning)<br>(CT, CT-Panoramic,<br>Panoramic, Ceph) | Same | | | Pixel<br>Number | 1024x1280(With<br>binning)<br>(CT, CT-Panoramic) | 1024x1280(With<br>binning)<br>(CT, CT-Panoramic) | Same | | | | 2560x2048 (Without<br>binning)<br>(CT, CT-Panoramic,<br>Ceph) | 2560x2048 (Without<br>binning)<br>(CT, CT-Panoramic,<br>Ceph) | Same | | | | 1900 x 120<br>(Panoramic) | 1900 x 120<br>(Panoramic) | Same | | | | 2560 x 2048<br>(Cephalometric) | 2560 x 2048<br>(Cephalometric) | Same | | | Size of<br>Area<br>Receiving<br>X-ray | 253.95mm x 317.44mm<br>(CT, CT-Panoramic)<br>230mm x 15mm<br>(Panoramic) | 253.95mm x 317.44mm<br>(CT, CT-Panoramic)<br>230mm x 15mm<br>(Panoramic) | Same | | | | | | Image: Prexion3D logo with text "make IT visible" | | | | 239mm x 302mm<br>(Ceph) | 253.95mm x 317.44mm<br>(Ceph) | Smaller | | | Number of<br>Bits | 16bits (CT, Panorama, Ceph) | 16bits (CT, Panorama, Ceph) | Same | | Scanner | SID/SOD | 700mm/ 420mm (CT, CT-Panoramic, Panoramic)<br>1000mm / 840mm (Ceph)…