Who is the manufacturer of PreXion3D Explorer EX?

Prexion Corporation filed the 510(k) submission for PreXion3D Explorer EX (K193329).

What is the FDA product code for PreXion3D Explorer EX?

OAS. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for PreXion3D Explorer EX?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PreXion3D Explorer EX?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PreXion3D Explorer EX

K193329 · Prexion Corporation · OAS · Apr 9, 2020 · Radiology

Device Facts

Record ID	K193329
Device Name	PreXion3D Explorer EX
Applicant	Prexion Corporation
Product Code	OAS · Radiology
Decision Date	Apr 9, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	Pediatric

Intended Use

PreXion3D Explorer EX is intended to produce two-dimensional digital x-ray images including panoramic 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. 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. Use of equipment and exposure settings designed for adults of average size can result in excessive radiation exposure for a smaller patient. Studies have shown that pediatic patients may be more radiosensitive than adults (i.e., the cancer risk per unit dose of ionizing radiation is higher), and so unnecessary radiation exposure is of particular concern for pediatric patients.

Device Story

PreXion3D Explorer EX is a computed tomography X-ray system for dental/maxillofacial imaging. It uses a rotating arm with an X-ray generator and flat panel detector to capture absorption data while rotating around a patient's head. The system reconstructs 2D panoramic and 3D CT images on a console. Operated by healthcare professionals in clinical settings, the device provides diagnostic images for clinical decision-making. Modifications from the predicate include adding a panoramic scan function, new FOV options, and updated user interface components (chinrest, touch panel, mirror) derived from the PreXion3D Excelsior. The device is intended to support diagnosis in dental and ENT applications.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and imaging performance (IEC 61223-3-4/5). An American board-certified radiologist confirmed that images produced with the modified detector effective area are of diagnostic quality.

Technological Characteristics

Computed tomography X-ray system; FPD (TFT) detector; 90-110kV tube voltage; 1-5mA tube current; 0.3mm x 0.3mm focal spot. Materials: polycarbonate (chinrest), silicone rubber (forehead holder/handle grip). Connectivity: DICOM (NEMA PS 3.1-3.20). Software: IEC 62304 compliant. Non-sterile. Standalone console-based reconstruction.

Indications for Use

Indicated for adult and pediatric patients (≥21 kg, ≥113 cm) for 2D (panoramic) and 3D digital X-ray imaging of dental, oral, maxillofacial, ENT, and neck regions as diagnostic support.

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 Explorer (K190320)

Reference Devices

PreXion3D Excelsior (K181983)

Related Devices

K173878 — PreXion3D Excelsior · Prexion Corporation · Jan 19, 2018
K221525 — PreXion3D Explorer PRO · Prexion Corporation · Jul 22, 2022
K190320 — PreXion3D Explorer · Prexion Corporation · Apr 15, 2019
K161881 — PreXion3D Excelsior · Prexion Corporation · Oct 3, 2016
K120948 — PREXION 3D · The Yoshida Dental Mfg. Co., Ltd. · Dec 21, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. PreXion Corporation % Hiroaki Takahashi General Manager, Quality Assurance & Regulatory Division 1-14-1, Kanda Suda-cho Chiyoda-ku. Tokyo 101-0041 JAPAN April 9, 2020 ### Re: K193329 Trade/Device Name: PreXion3D Explorer EX Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: March 16, 2020 Received: March 19, 2020 #### 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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K193329 Device Name PreXion3D Explorer EX #### Indications for Use (Describe) PreXion3D Explorer EX is intended to produce two-dimensional digital x-ray images including panoramic 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. 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. Use of equipment and exposure settings designed for adults of average size can result in excessive radiation exposure for a smaller patient. Studies have shown that pediatic patients may be more radiosensitive than adults (i.e., the cancer risk per unit dose of ionizing radiation is higher), and so unnecessary radiation exposure is of particular concern for pediatric patients. Type of Use (Select one or both, as applicable) | <div style="display:inline-block;"><div>☑</div>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block;"><div>☐</div>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | |-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| #### 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 shows 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" with the "IT" in blue. Above and to the right of the name is a blue swoosh design with a gray shadow, adding a modern and dynamic element to the logo. # 510(k) Summary PreXion3D Explorer EX Device Name: ## K193329 #### 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 November 29th, 2019 #### 4. Device Identification | Product/Trade Name: | PreXion3D Explorer EX | |-----------------------|----------------------------------| | Common Name: | Computed Tomography X-ray System | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | OAS | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for PreXion. The logo features the word "PreXion" in a stylized font, with the "X" being slightly larger than the other letters. Below the company name is the tagline "make IT visible" in a smaller font. Above and to the right of the company name is a blue and white graphic design. #### 5. Legally Marketed Predicate Device(s) and Reference Device | Predicate Device: | | |-----------------------|----------------------------------| | Product/Trade Name: | PreXion3D Explorer | | 510(K) Number: | K190320 | | Common Name: | Computed Tomography X-ray System | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | OAS | | Reference Device: | | | Product/Trade Name: | PreXion3D Excelsior | | 510(K) Number: | K181983 | | Common Name: | Computed Tomography X-ray System | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | Class II | #### 6. Indication for Use Statement PreXion3D Explorer EX is intended to produce two-dimensional digital x-ray images including panoramic 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. 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. Use of equipment and exposure settings designed for adults of average size can result in excessive radiation exposure for a smaller patient. Studies have shown that pediatric patients may be more radiosensitive than adults (i.e., the cancer risk per unit dose of ionizing radiation is higher), and so unnecessary radiation exposure is of particular concern for pediatric patients. #### 7. Device Description <Summary of Predicate Device (PreXion3D Explorer)> PreXion3D Explorer (Predicate Device) 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. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for PreXion. The logo features the word "PreXion" in a stylized font, with the "Pre" in a lighter gray and the "Xion" in a darker gray. Below the word "PreXion" is the tagline "make IT visible" in a smaller font. Above the word "PreXion" is a blue swoosh design, with a gray shadow behind it. 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, CT-Panoramic scan) and Cephalometric Scan <Summary of Modification> The Primary intention of this Traditional 510(k) submission is to reflect the customers' voice (which does not affect to product safety and performance) to the predicate device and to expand the line-up of PreXion3D Explorer Family. #### Modifications: - 1. To apply Chinrest/Forehead Holder which are used in PreXion3D Excelsior (K181983) - To add a touch panel and a mirror for ease of use which is used in PreXion3D Excelsior 2. (K181983) - 3. To modify middle size FOV: From "15 x 8" to "15 x 10" - 4. To add middle size FOV: 10 x 10 - 5. To add Panoramic Scan Function which is used in PreXion3D Excelsior (K181983) - To change detector's effective area (smaller by 1.5mm due to vendor design change) 6. - 7. To disable Cephalometric Scan Function by replacing the console software. The console software is modified to do so. As "Table-6A: Comparison of Characteristics" shows that PreXion3D Explorer EX (Device in concern) is the equivalent with the predicate device, PreXion3D Explorer (K190320), and it appears to be PreXion3D Explorer without Cephalometric Scan Function. <Summary of Device Description in Concern> PreXion3D Explorer EX 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 EX 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) and the tomographic image (CT scan, CT-Panoramic scan, Panoramic Scan). {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Prexion. The word "Prexion" is written in a cursive font, with the "P" being larger than the other letters. Below the word "Prexion" is the phrase "make IT visible" in a smaller, sans-serif font. Above and to the right of the word "Prexion" is a blue and white swoosh design. #### Substantial Equivalence Discussion 8. The following table compares the PreXion3D Explorer EX 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. | | Subject Device | Predicate Device | Reference Device | | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | Manufacturer | PreXion Corporation | PreXion Corporation | PreXion Corporation | Comparis | | Trade Name | PreXion3D Explorer EX | PreXion3D Explorer | PreXion3D Excelsior | on to Predicate | | 510(k) Number | K193329/S001 | K190320 | K181983 | N/A | | Product Code | OAS | OAS | OAS | Same | | Regulation Number | OAS: 21 CFR 892.1750 | OAS: 21 CFR 892.1750 | OAS: 21 CFR 892.1750 | Same | | Regulation Name | OAS: Computed tomography x-ray system | OAS: Computed tomography x-ray system | OAS: Computed tomography x-ray system | Same | | Device Classification Name | X-Ray, Tomography, Computed, Dental | X-Ray, Tomography, Computed, Dental | X-Ray, Tomography, Computed, Dental | Same | | Indications for use: | PreXion3D Explorer EX is intended to produce two- dimensional digital x- ray images including panoramic 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. 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 | 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. | PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three-dimensional digital x-ray images of the dental(oral). maxillofacial, and ENT (Ear, Nose and Throat) 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 | Cephalome tric Scan Function is disabled by the console software. Otherwise equivalent | #### Table-6A: Comparison of Characteristics {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for PreXion. The logo features the name "PreXion" in a light gray, elegant font. Below the name is the tagline "make IT visible" in a smaller, sans-serif font, with "IT" in a slightly darker shade. Above and to the right of the name is a stylized graphic consisting of two curved shapes in shades of blue and gray, creating a sense of depth and movement. | | | | Patient/User Characteristics | | | | |----------------------------------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------| | Target Population | | | Children aged 6 (except infants) to elderly | Children aged 6 (except infants) to elderly | Children aged 6 (except infants) to elderly | Same | | Anatomical Site | | | The dental, oral, maxillofacial region ENT (Ear, Nose and Throat) and neck region | The dental, oral, maxillofacial region ENT (Ear, Nose and Throat) and neck region | The dental, oral, maxillofacial region ENT (Ear, Nose and Throat) and neck region | Same | | | | | | | | | | Users | | | Health care professionals | Health care professionals | Health care professionals | Same | | | | | Technological Characteristics and Performance | | | | | Patient Contact | | | CHIN REST: polycarbonate Forehead Holder: silicone rubber HANDLE GRIP: silicone rubber | CHINREST: polycarbonate HEADREST: carbon BELT: polyvinyl chloride | CHIN REST: polycarbonate Forehead Holder: silicone rubber HANDLE GRIP: silicone rubber | Same materials are used | | Material | | | | | | | | Sterility | | | Non-sterile | Non-sterile | Non-sterile | Same | | X-ray Generation Device | Tube Voltage | | 90-110KV | 90-110KV | 60-110KV | Same or Equivalent | | | Pulse Exposure function | | Yes | Yes | Yes | Same | | | Tube Current | | 1-5mA | 1-3mA | 1-6mA | Tube Current is similar. Added according with Panoramic | | | Focal Spot Size | 0.3mm x 0.3mm | 0.3mm x 0.3mm | 0.3mm x 0.3mm | Same | | | | Detector | FPD (TFT) | FPD (TFT) | FPD (TFT) | Same | | | | Pixel Size | 248 µm x248µm (With binning) (CT, CT-Panoramic, Panoramic) 124 µm x124µm (Without binning) (CT, CT-Panoramic, Panoramic) | 248 µm x248µm (With binning) (CT, CT-Panoramic, Ceph) 124 µm x124µm (Without binning) (CT, CT-Panoramic, Ceph) | 250 µm x250µm (With binning) (CT, CT-Panoramic. Panoramic) 125 µm x125µm (Without binning) (CT, CT-Panoramic) 125µm x 125µm (Panoramic) 140 µm x 140µm (Ceph) | Equivalent | | | X-ray Image Capturin g Device | Pixel Number | 1024x1280(With binning) (CT, CT-Panoramic) 2560x2048(Without binning) (CT, CT-Panoramic) 1900 x 120 (Panoramic) | 1024x1280(With binning) (CT, CT-Panoramic) 2560x2048(Without binning) (CT, CT-Panoramic, Ceph) 1024x1280(With binning) | 1024x1280 (CT) 128x128 (Panoramic) 2112x1754 (Cephalometric) | Comparing to K190320, Device is | | | | Size of Area Receivin g X-ray | 253.95mm x 317.44mm (CT, CT-Panoramic) 230mm x 15mm (Panoramic) | 253.95mm x 317.44mm (CT, CT-Panoramic, Ceph) | 160mm x 128mm (CT) 160mm x 12.5mm (Panoramic) 295.68 x 245.56mm (Ceph) | same, just the use is changed so that Ceph is disabled and Panoramic Scan is added. | | | | Number of Bits | 16bits (CT, CT- Panoramic, Panoramic) | 16bits (CT, CT- Panoramic, Ceph) | 16bits (CT, CT- Panoramic, Panoramic) 14bits (Ceph) | | | | Scanner | SID/SO D | 700mm/ 420mm (CT, CT-Panoramic. Panoramic) | 700mm/ 420mm (CT, CT- Panoramic, Ceph) | 700mm/ 470mm (CT, Panoramic) 1735mm / 1500mm (Ceph) | Comparing to K190320, Device is same, just the use is changed so that Ceph is disabled and Panoramic Scan is added. | | | | Dimensi on (WxDxH) | 880 mm x 1237 mm x 2268 mm (CT, CT- Panoramic, Panoramic) | 880 mm x 1237 mm x 2268 mm (CT, CT- Panoramic, Ceph) | 930 mm x 1230 mm x 2220 mm (CT, CT- Panoramic, Panoramic) 1816 mm x 1230 mm x | K190320, geometry is same | | | | | | | 2220 mm (with Ceph) | | | | | Weight | 185 kg (CT, CT- Panoramic, Panoramic) | 165 kg (CT, Panoramic, Ceph) | 165 kg (CT, Panoramic) 200kg (Ceph) | Similar | | | Imaging Mode | | CT scan, CT- Panoramic, Panoramic scan | CT scan, CT-Panoramic, Cephalometric radiography | CT scan, CT- Panoramic, Panoramic scan, Cephalometric radiography | No Cephalome tric Radiograph y Added Panoramic scan (Identical to K181983) | | | Panoramic Scan Performance (Scan Time) | | 8-16sec | 18sec | 8-16sec | Scan Time is improved or same. | | | Cephalometric Radiography (Scan Time) | | N/A | 0.16 sec | 0.5-0.8 sec | No Cephalome tric Radiograph y | | | CT Scan Performa nce | Scan Time | 10-20sec | 10-20sec | 5.2-23.6sec | Same or Similar | | | | FOV (Voxel Size) | Diameter 150mm x H156mm (0.100 - 0.200mm) Diameter 150mm x H100mm (0.100 - 0.200mm) | Diameter 150mm x H156mm (0.100 - 0.200mm) Diameter 150mm x H78mm (0.100 - 0.200mm) | Diameter 150mm x H130mm (0.100 - 0.200mm) Diameter 150mm x H81 (0.200mm) Diameter 100mm x H81mm (0.100 - 0.200mm) | Added one middle size FOV and gets bigger in middle size FOV for user requiremen t. | | | | | Diameter 100mm x H100mm (0.100 - 0.200mm) Diameter 50mm x H50mm (0.100 - 0.200mm) | Diameter 50mm x H50mm (0.100 - 0.200mm) | Diameter 100mm x H50mm (0.100 - 0.200mm) Diameter 50mm x H50mm (0.100 - 0.200mm) | | | | | | | | | | | | Spatial Resolution | | Standard mode: 50%MTF: 0.95LP/mm 20%MTF:2.0LP/mm Rapid Mode: 50%MTF: 0.95LP/mm 20%MTF:2.0LP/mm | Standard mode: 50%MTF: 0.95LP/mm 20%MTF:2.0LP/mm Rapid Mode: 50%MTF: 0.95LP/mm 20%MTF:2.0LP/mm | Standard mode 50%MTF: 1.2LP/mm 20%MTF:2.3LP/mm Rapid Mode 50%MTF: 1.2LP/mm 20%MTF:2.3LP/mm | Same or equivalent | | | | | | | | | | | | | High Resolution mode: | High Resolution mode: | High Resolution mode: | | | {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for PreXion. The logo features the name "PreXion" in a light gray, sans-serif font. Below the name is the tagline "make IT visible" in a smaller font, with the "IT" in blue. Above and to the right of the name is a blue and gray swoosh design, adding a modern and dynamic element to the logo. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image contains the logo for PreXion. The logo features the company name in a stylized font, with the "IT" in "make IT visible" in blue. Above and to the right of the name is a blue and white swoosh design, adding a modern and dynamic element to the overall branding. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for PreXion. The logo features the name "PreXion" in a light gray, sans-serif font. Below the name is the tagline "make IT visible" in a smaller font. Above and to the right of the name is a blue and gray swoosh design. | | 50%MTF: 0.95LP/mm 20%MTF:2.0LP/mm | 50%MTF: 0.95LP/mm 20%MTF:2.0LP/mm | 50%MTF: 1.2LP/mm 20%MTF:2.3LP/mm | | |--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | High contrast mode: 50%MTF: 0.95LP/mm 20%MTF:2.0LP/mm | High contrast mode: 50%MTF: 0.95LP/mm 20%MTF:2.0LP/mm | High contrast mode: 50%MTF: 1.2LP/mm 20%MTF:2.3LP/mm | | | Viewer Software (Image Analysis System Software) | Display High- resolution 2D and 3D Images Function Image Processing Function includes Airway measurement Image Operation Function Output Function | Display High-resolution 2D and 3D Images Function Image Processing Function include Airway measurement Image Operation Function Output Function | Display High-resolution 2D and 3D Images Function Image Processing Function include Airway measurement Image Operation Function Output Function | Same | | Console Software System Settings | CT Scan include CT-Panoramic mode | CT Scan include CT-Panoramic mode | CT Scan include CT-Panoramic mode | Same | | Applied Standard | | | | | | Electrical Safety Standard | ANSI/AAMI ES60601-1 | ANSI/AAMI ES60601-1 | ANSI/AAMI ES60601-1 | | | Electromagnetic Compatibility Standard | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | | | Radiation Safety Standard | IEC 60601-1-3 | IEC 60601-1-3 | IEC 60601-1-3 | | | Electrical Equipment Usability Safety Standard | IEC 60601-1-6 | IEC 60601-1-6 | IEC 60601-1-6 | | | Usability Engineering Standard | IEC 62366 -1 | IEC 62366 | IEC 62366 | | | Software Lifecycle Process Standard | IEC 62304 | IEC 62304 | IEC 62304 | Same | | Essential performance of dental extra-oral X- ray equipment Standard | IEC 60601-2-63 | IEC 60601-2-63 | IEC 60601-2-63 | | | Acceptance tests of Imaging performance of dental X-ray equipment Standard | IEC 61223-3-4 | IEC 61223-3-4 | IEC 61223-3-4 | | | Acceptance tests of Imaging performance of computed tomography X-ray equipment Standard | IEC 61223-3-5 | IEC 61223-3-5 | IEC 61223-3-5 | | | Laser Safety Standard | IEC 60825-1 | IEC 60825-1 | IEC 60825-1 | | | Risk Management Standard | ISO 14971 | ISO 14971 | ISO 14971 | | | DICOM Standard | NEMA PS 3.1 - 3.20 | NEMA PS 3.1 - 3.20 | NEMA PS 3.1 - 3.20 | | | Biocompatibility Standard Compliance | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | | | Biocompatibility Standard Compliance | ISO 10993-5 | ISO 10993-5 | ISO 10993-5 | | | Biocompatibility Standard Compliance | ISO 10993-10 | ISO 10993-10 | ISO 10993-10 | | {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for Prexion, a company that aims to make IT visible. The logo features the company name in a stylized font, with "Pre" in a cursive-like font and "Xion" in a more standard font. Below the name is the tagline "make IT visible" in a smaller font. A blue swoosh design arches over the "Xion" part of the name, adding a modern and technological feel to the logo. #### 9. Non-Clinical Performance Data As part of demonstrating safety and effectiveness of PreXion3D Explorer EX and in showing substantial equivalence to the predicate device, PreXion Corporation completed a number of non-clinical performance tests. The PreXion3D Explorer EX meets all the requirements for overall design, biocompatibility, performance, and electrical safety results confirming that the design output meets the design inputs and specifications for the device. Summary of performance testing performed for each modification stated in Section 7: - 1. To apply Chinrest/Forehead Holder which are used in PreXion3D Excelsior (K181983) The biocompatibility is safe because same materials as to marketed device are used. - 2. To add a touch panel and a mirror for ease of use which is used in PreXion3D Excelsior (K181983) IEC60601-1 test was performed by the outside test lab qualified with ISO17025. Regarding added mirror, risk management was performed and decided it's acceptable. - 3. To modify middle size FOV: From "15 x 8" to "15 x 10" System test was performed to confirm that 15 x 10 of middle size FOV is valid. - 4. To add middle size FOV: 10 x 10 System test was performed to confirm that 10 x 10 of middle size FOV is valid. - 5. To add Panoramic Scan Function which is used in PreXion3D Excelsior (K181983) Imaging performance test was performed and has confirmed to comply with IEC61223-3-4. - 6. To change detector's effective area (smaller by 1.5mm due to vendor design change) An American board-certified radiologist has confirmed that images with the modification as a change to the detector's effective area is of diagnostic quality. {12}------------------------------------------------ Image /page/12/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" in a lighter gray and "Xion" in a darker gray. Below the company name is the tagline "make IT visible" in a smaller, sans-serif font. Above and to the right of the company name is a swooping, curved graphic in shades of blue and white, adding a modern and dynamic element to the logo. 7. To disable Cephalometric Scan Function by replacing the console software. The console software is modified to do so. System test was performed to confirm that system is valid including the function of disabling Cephalometric Scan Function. The PreXion3D Explorer EX passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device: - Biocompatibility testing per ISO 10993-1, ISO 10993-5 and ISO 10993-10 . - Electrical safety testing per ABSI/AAMI ES 60601-1, IEC 60601-1-3 and IEC 60601-1-6 - . Electromagnetic Safety testing per IEC 60601-1-2 - . Dental extra-oral X-ray equipment testing per IEC 60601-2-63 - . Acceptance testing of X-ray equipment per IEC 61223-3-4 and IEC 61223-3-5 - Laser safety testing per IEC 60825-1 ● - . DICOM testing per NEMA PS 3.1 - 3.20 - . Usability testing per IEC 62366-1 - . Software verification and validation per IEC 62304 - Storage and Transport Testing per ISO 4180 - Software Documentation per: "Guidance for the Content of Premarket Submissions for Software . Contained in Medical Devices - Establish the substantial equivalence of an SSXI to a previously cleared conventional radiographic ● SSXI per: "Guidance for the Submission of 510(k) s for Solid State X-ray Imaging Devices" - Cybersecurity Activities per: "Cybersecurity-for-Networked-Medical-Devices-Containing-Off-the-Shelf-(OTS)-Software---Guidance-for-Industry", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" #### 10. Clinical Performance Data There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the logo for PreXion. The logo features the name "PreXion" in a stylized font, with "Pre" in a darker gray and "Xion" in a lighter gray. Below the name is the tagline "make IT visible" in a smaller, sans-serif font. Above and to the right of the name is a curved, blue graphic element with a subtle shadow effect, adding a sense of depth and dimension to the logo. #### 11. Cybersecurity Activities We make post-market Cybersecurity actions as follows: - 1.…