PreXion3D Explorer
Device Facts
| Record ID | K190320 |
|---|---|
| Device Name | PreXion3D Explorer |
| Applicant | Prexion Corporation |
| Product Code | OAS · Radiology |
| Decision Date | Apr 15, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
PreXion3D Explorer 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.
Device Story
PreXion3D Explorer is a dental/maxillofacial X-ray system; captures 2D (panoramic, cephalometric) and 3D (CT) images. Scanner rotates around patient head; X-ray generator and flat panel detector (FPD) mounted on opposite sides of rotation arm. System includes Console for operation, data management, and image reconstruction. Used in clinical settings by healthcare professionals. Output includes 2D/3D images for diagnostic support; aids in treatment planning and growth assessment. Benefits include high-resolution imaging for dental/ENT/maxillofacial diagnosis.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including biocompatibility, electrical safety, electromagnetic compatibility, and imaging performance verification per international standards (IEC/ISO).
Technological Characteristics
Computed tomography X-ray system; FPD (TFT) detector; 90-110kV tube voltage; 1-3mA tube current; 0.3mm x 0.3mm focal spot. Materials: polycarbonate (chin rest), carbon (head support), silicone rubber (handle grip). Connectivity: DICOM (NEMA PS 3.1-3.20). Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 62366-1, IEC 62304, IEC 60601-2-63, IEC 61223-3-4/5, IEC 60825-1, ISO 14971, ISO 10993-1/5/10.
Indications for Use
Indicated for adult and pediatric patients (aged 6+) requiring 2D (panoramic, cephalometric) or 3D digital X-ray imaging of dental, oral, maxillofacial, ENT, and neck regions. Cephalometric imaging includes hand/wrist for growth/maturity assessment. No specific contraindications listed.
Regulatory Classification
Identification
A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- PreXion3D Excelsior (K181983)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 15, 2019
PreXion Corporation % Hiroaki Takahashi General Manager, Quality Assurance & Regulatory Division 1-14-1, Kanda Suda-cho Chiyoda-ku, Tokyo101-0041 JAPAN
Re: K190320
Trade/Device Name: PreXion3D Explorer Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: February 8, 2019 Received: February 13, 2019
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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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 and to the right of the text is a curved, blue and gray graphic element, adding a modern and technological feel to the logo.
# Section 5 – 510(k) Summary
Device Name: PreXion3D Explorer
# K190320
## 1. Submission Sponsor
PreXion Corporation 1-14-1, Kanda Suda-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
February 8th, 2019
#### 4. Device Identification
| Trade/Proprietary Name: | PreXion3D Explorer |
|-------------------------|---------------------------------------|
| 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 |
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Image /page/4/Picture/1 description: The image shows the logo for PreXion, a company that appears to be in the IT sector. The logo features the company name in a stylized font, with the "Pre" portion in a light gray color and the "Xion" portion in a darker gray. Above the "Xion" part of the name is a blue swoosh design. Below the company name is the tagline "make IT visible" in a smaller font.
### 5. Legally Marketed Predicate Device(s)
K181983, PreXion3D Excelsior, PreXion Corporation
#### 6. Indication for Use Statement
PreXion3D Explorer 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.
#### 7. Device Description
PreXion3D Explorer 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 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 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, CT-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.
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) applied to the X-ray tube brings the following features.
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Image /page/5/Picture/1 description: The image shows the logo for PreXion. The logo features the company name in a stylized font, with the word "Pre" in a lighter shade of gray and "Xion" in a darker shade. Below the company name is the tagline "make IT visible" in a smaller font. Above the company name is a blue swoosh design that adds a modern and dynamic element to the logo.
· 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.
# 8. Substantial Equivalence Discussion
The following table compares the PreXion3D Explorer to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, 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.
| Manufacturer | PreXion Corporation | PreXion Corporation | | | |
|------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------|
| Trade Name | PreXion3D Explorer | PreXion3D Excelsior | Comparison to<br>Predicate | | |
| 510(k) Number | TBD | K181983 | N/A | | |
| Product Code | OAS | OAS | Same | | |
| Regulation Number | OAS: 21 CFR 892.1750 | OAS: 21 CFR 892.1750 | Same | | |
| Regulation Name | OAS: Computed tomography x-<br>ray system | OAS: Computed tomography x-<br>ray system | Same | | |
| | | | | | |
| Device Classification<br>Name | | X-Ray, Tomography, Computed,<br>Dental | X-Ray, Tomography, Computed,<br>Dental | Same | |
| Indications for use: | | PreXion3D Explorer is intended<br>to produce two-dimensional<br>digital x-ray images including<br>panoramic and cephalometric<br>image, and three-dimensional<br>digital x-ray images of the<br>dental, oral, maxillofacial region,<br>ENT (Ear, Nose and Throat) and<br>neck region at the direction of<br>healthcare professionals as<br>diagnostic support for adult and<br>pediatric patients.<br>Cephalometric imaging also<br>includes the hand and wrist to<br>obtain carpus images for growth<br>and maturity assessment. | PreXion 3D Excelsior is intended<br>to produce two-dimensional<br>digital panoramic and<br>cephalometric images, and<br>three-dimensional digital x-ray<br>images of the dental(oral),<br>maxillofacial, and ENT (Ear,<br>Nose and Throat) region at the<br>direction of healthcare<br>professionals as diagnostic<br>support for adult and pediatric<br>patients.<br>Cephalometric imaging also<br>includes the hand and wrist to<br>obtain carpus images for<br>growth and maturity<br>assessment. | Minor wording<br>differences do<br>not raise any<br>additional<br>questions of<br>safety or<br>efficacy. | |
| | | | | | |
| Target Population | | Children aged 6 (except infants)<br>to elderly | Children aged 6 (except infants)<br>to elderly | Same | |
| Anatomical Site | | The dental, oral, maxillofacial<br>region<br>ENT (Ear, Nose and Throat) and<br>neck region | The dental, oral, maxillofacial<br>region<br>ENT (Ear, Nose and Throat) and<br>neck region | Same | |
| Users | | Health care professionals | Health care professionals | Same | |
| | Technological Characteristics and Performance | | | | |
| Patient Contact Material | | CHIN REST: polycarbonate<br>HEAD SUPPORT: carbon<br>HANDLE GRIP: silicone rubber | CHIN REST: polycarbonate<br>HEADREST: silicone rubber<br>BELT: polyvinyl chloride | Biocompatibility<br>test results<br>support that the<br>material is safe<br>for the intended<br>use. | |
| Sterility | | Non-sterile | Non-sterile | Same | |
| X-ray<br>Generation<br>Device | Tube<br>Voltage | 90-110KV | 60-110KV | Applied current<br>is reduced so<br>that the dose<br>level is<br>equivalent. | |
| | Pulse<br>Exposure<br>function | Yes | Yes | Same | |
| | Tube<br>Current | 1-3mA | 1-6mA | Applied current<br>is reduced so<br>that the dose<br>level is<br>equivalent. | |
| | Focal Spot<br>Size | 0.3mm x 0.3mm | 0.3mm x 0.3mm | Same | |
| | Detector | FPD (TFT) | FPD (TFT) | Same | |
| X-ray Image<br>Capturing<br>Device | Pixel Size | 248 μm x248μm (With binning)<br>(CT, CT-Panoramic, Ceph) | 125 μm x125μm,125μm x250μm (CT) | | |
| | | 124 μm x124μm (Without<br>binning)<br>(CT, CT-Panoramic, Ceph) | 125 μm x 125μm (Panoramic) | | |
| | | | 140 μm x 140μm (Ceph) | | |
| | Pixel<br>Number | 1024x1280(With binning)<br>(CT, CT-Panoramic)<br>2560x2048(Without binning)<br>(CT, CT-Panoramic, Ceph) | 1280x1024 (CT)<br>128x1280 (Panoramic)<br>2112x1754 (Cephalometric) | FPD has been<br>changed and<br>gets bigger. The<br>performance<br>gets better. | |
| | Size of<br>Area<br>Receiving<br>X-ray | 253.95mm x 317.44mm<br>(CT, CT-Panoramic, Ceph) | 160mm x 128mm (CT)<br>160mm x 12.5mm (Panoramic)<br>295.68 x 245.56mm (Ceph) | | |
| | Number<br>of Bits | 16bits (CT, CT-Panorama, Ceph) | 16bits (CT, Panorama)<br>14bits (Ceph) | | |
| Scanner | SID/SOD | 700mm/ 420mm (CT, CT-<br>Panoramic, Ceph) | 700mm/ 470mm (CT,<br>Panoramic)<br>1735mm / 1500mm (Ceph) | Radius of<br>rotation gets<br>smaller so that<br>they are<br>substantially<br>equivalent. | |
| | Dimension<br>(WxDxH) | 880 mm x 1237 mm x<br>2268 mm (CT, CT-Panoramic,<br>Ceph) | 930 mm x 1230 mm x<br>2220 mm (CT, Panoramic)<br>1747 mm x 1230 mm x<br>2220 mm (with Ceph) | | |
| | Weight | 165 kg (CT, CT-Panoramic, Ceph) | 165 kg (CT, Panoramic)<br>200kg (Ceph) | Cephalo is<br>integrated, thus,<br>it gets lighter. | |
| | Imaging Mode | CT scan, CT-Panoramic scan,<br>Cephalometric radiography | CT scan, Panoramic scan,<br>Cephalometric radiography | Equivalent | |
| | | Panoramic Scan<br>Performance (Scan Time) | 18sec | 8-16sec | Irradiance level<br>is equivalent. |
| | | Cephalometric<br>Radiography (Scan Time) | 0.1 sec | 0.5-0.8 sec | Improved |
| CT Scan<br>Performance | Scan Time | 10-20sec | 5.2-25.6sec | Similar | |
| | FOV<br>(Voxel<br>Size) | Diameter 150mm x H156mm<br>(0.100 - 0.200mm)<br>Diameter 150mm x H78mm<br>(0.100 - 0.200mm)<br>Diameter 50mm x H50mm | Diameter 100mm x H81mm<br>(0.100 - 0.200mm)<br>Diameter 100mm x H50mm<br>(0.100 - 0.200mm)<br>Diameter 50mm x H50mm | FPD gets bigger<br>so that it can<br>scan larger<br>object. | |
# Table-5A: Comparison of Characteristics
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Image /page/6/Picture/1 description: The image contains the logo for PreXion. The logo features the name "PreXion" in a stylized font, with the "IT" in the tagline "make IT visible" in a slightly bolder font. Above and to the right of the name is a blue and white swoosh design, adding a modern and dynamic element to the logo.
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Image /page/7/Picture/1 description: The image shows the logo for PreXion. The logo features the company name in a light gray, italicized font, with the "IT" in "make IT visible" in blue. Above and behind the name is a curved, swooping graphic that transitions from light blue to white, adding a sense of motion and technology to the overall design.
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Image /page/8/Picture/1 description: The image shows the logo for PreXion. The logo features the company name in a stylized font, with the "Pre" in a lighter gray and the "Xion" in a darker gray. Above and to the right of the name is a blue and gray swoosh design. Below the company name is the tagline "make IT visible" in a smaller font.
| | (0.100 - 0.200mm) | (0.100 - 0.200mm) | |
|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| | | Diameter 150mm x H130mm<br>(0.100 - 0.200mm) | |
| Volume Size | 500x500x500<br>750x750x780 | 512x512x512<br>512x512x950<br>1024x1024x816<br>1024x1024x1515 | Volume Size is<br>smaller; thus,<br>the file size gets<br>smaller. |
| Dose Level<br>(CTDIw) | Standard (110KV, 2mA, 10s)<br>15cm: 1.7mGy<br>5cm: 0.5mGy<br><br>High Definition (110KV, 2.0mA, 18s)<br>15cm: 3.1mGy<br>5cm: 0.9mGy<br><br>Ultra-High Definition (110KV, 2.0mA, 20s)<br>15cm: 2.3mGy<br>5cm: 0.7mGy<br><br>Standard Child (90KV, 1mA, 10s)<br>15cm: 0.5mGy<br>5cm: 0.1mGy | Standard (110KV, 2.4mA, 9.6s)<br>10cm: 2.9mGy<br>5cm: 1.9mGy<br><br>Rapid (110KV, 2.4mA, 5.2s)<br>10cm: 0.9mGy<br>5cm: 0.8mGy<br><br>High Definition (110KV, 2.4mA, 12.8s)<br>10cm: 4.9mGy<br>5cm: 3.2mGy<br><br>Ultra-High Definition (110KV, 2.4mA, 23.6s)<br>10cm: 8.7mGy<br>5cm: 4.3mGy<br><br>Standard Child (95KV, 1.6mA, 9.6s)<br>10cm: 1.4mGy<br>5cm: 1.0mGy<br><br>Rapid Child (95KV, 1.6mA, 5.2s)<br>10cm: 0.5mGy<br>5cm: 0.4mGy<br><br>Complete (110KV, 2.4mA, 19.2s)<br>10cm: 5.8mGy<br><br>Complete Child (95KV, 1.6mA, 19.2s)<br>10cm: 2.9mGy | Dose Level is<br>similar and<br>improved. |
| Spatial Resolution | Standard mode:<br>50%MTF: 0.95LP/mm<br>20%MTF:2.0LP/mm<br><br>Rapid Mode:<br>50%MTF: 0.95LP/mm<br>20%MTF:2.0LP/mm | Standard mode:<br>50%MTF: 1.2LP/mm<br>20%MTF:2.3LP/mm<br><br>Rapid Mode:<br>50%MTF: 1.2LP/mm<br>20%MTF:2.3LP/mm | Spatial<br>Resolution is<br>similar and<br>improved. |
| | 50%MTF: 0.95LP/mm<br>20%MTF:2.0LP/mm | 50%MTF: 1.2LP/mm<br>20%MTF:2.3LP/mm | |
| | High contrast mode:<br>50%MTF: 0.95LP/mm<br>20%MTF:2.0LP/mm | High contrast mode:<br>50%MTF: 1.2LP/mm<br>20%MTF:2.3LP/mm | |
| | Display High-resolution 2D and<br>3D Images Function | Display High-resolution 2D and<br>3D Images Function | |
| Viewer Software (Image<br>Analysis System<br>Software) | Image Processing Function<br>includes Airway measurement<br>Image Operation Function | Image Processing Function<br>include Airway measurement<br>Image Operation Function | Same |
| Console Software<br>System Settings | Output Function<br>CT Scan<br>include CT-Panoramic mode | Output Function<br>CT Scan<br>include CT-Panoramic mode | Same |
| | Applied Standard | | |
| Electrical Safety Standard | ANSI/AAMI ES60601-1 | ANSI/AAMI ES60601-1 | |
| Electromagnetic<br>Compatibility Standard | IEC 60601-1-2 | IEC 60601-1-2 | |
| Radiation Safety Standard | IEC 60601-1-3 | IEC 60601-1-3 | |
| Electrical Equipment<br>Usability Safety Standard | IEC 60601-1-6 | IEC 60601-1-6 | |
| Usability Engineering<br>Standard | IEC 62366 -1 | IEC 62366 | |
| Software Lifecycle<br>Process Standard | IEC 62304 | IEC 62304 | |
| Essential performance of<br>dental extra-oral X-ray<br>equipment Standard | IEC 60601-2-63 | IEC 60601-2-63 | |
| Acceptance tests of<br>Imaging performance of<br>dental X-ray equipment<br>Standard | IEC 61223-3-4 | IEC 61223-3-4 | Same |
| Acceptance tests of<br>Imaging performance of<br>computed tomography X-<br>ray equipment Standard | IEC 61223-3-5 | IEC 61223-3-5 | |
| Laser Safety Standard | IEC 60825-1 | IEC 60825-1 | |
| Risk Management<br>Standard | ISO 14971 | ISO 14971 |…
