PreXion3D Expedition

K222150 · Prexion Corporation · OAS · Jan 12, 2023 · Radiology

Device Facts

• Record ID: K222150
• Device Name: PreXion3D Expedition
• Applicant: Prexion Corporation
• Product Code: OAS · Radiology
• Decision Date: Jan 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

PreXion3D Expedition 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.

Device Story

Scanner generates X-ray and detects image data; console operates scanner and manages data. Rotation arm rotates around patient head; X-ray generator and flat panel detector (FPD) mounted on opposite sides. X-ray absorption data transferred to console for image reconstruction (CT, panoramic, cephalometric). Used in clinical settings by healthcare professionals. Output includes 2D/3D images for diagnostic support. Benefits include visualization of maxillofacial/ENT structures for clinical decision-making.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility, electrical safety, electromagnetic compatibility, and software verification/validation.

Technological Characteristics

Computed tomography X-ray system; FPD (IGZO TFT matrix) with CsI:Tl scintillator; 90-110 kV tube voltage; 1-5.3 mA tube current; 0.3mm x 0.3mm focal spot. Connectivity via DICOM. Software lifecycle per IEC 62304. Materials: polycarbonate (chin rest), silicone rubber (forehead holder, handle grip).

Indications for Use

Indicated for adult and pediatric patients (≥21 kg, ≥113 cm) requiring 2D (panoramic, cephalometric) or 3D digital X-ray imaging of dental, oral, maxillofacial, ENT, and neck regions; includes carpus imaging for growth assessment.

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 PRO (K203784)

Reference Devices

• PreXion3D Excelsior (K181983)

Submission Summary (Full Text)

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January 12, 2023

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 and Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.

PreXion Corporation % Kenji Tanaka Quality Assurance and Regulatory Affairs Division 1-14-1. Kandasuda-cho Chivoda-ku. Tokyo 101-0041 JAPAN

#### Re: K222150

Trade/Device Name: PreXion3D Expedition Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: December 1, 2022 Received: December 15, 2022

#### Dear Kenji Tanaka:

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

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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

2023.01.12
09:13:16
-05'00'
Lu Jiang

Lu Jiang, 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

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## Indications for Use

510(k) Number (if known) K222150

Device Name PreXion3D Expedition

#### Indications for Use (Describe)

PreXion3D Expedition 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

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.

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Image /page/3/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. Below the company name is the tagline "make IT visible" in a smaller font. Above and behind the company name is a swooping graphic in blue and gray, adding a modern and dynamic element to the logo.

## 510(k) Summary

# PreXion3D Expedition

## K222150

## 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: [e-mail] Office number: [phone]

## 2. Submission Correspondent

Same as above

## 3. Date Prepared

July 13th, 2022

## 4. Device Identification

Trade/Proprietary Name: PreXion3D Expedition

| 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. The logo features the word "PreXion" in a light gray, sans-serif font. Below the name is the phrase "make IT visible" in a smaller font, with the "IT" in blue. Above and behind the name is a blue arc with a gray shadow, giving the logo a modern and technological feel.

### 5. Legally Marketed Predicate Device(s) and Reference Device

Predicate Device: K203784. PreXion3D Explorer PRO. PreXion Corporation Reference Device: K181983, PreXion3D Excelsior, PreXion Corporation

#### 6. Indication for Use Statement

PreXion3D Expedition 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 Expedition 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.

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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 light gray, elegant font, with the tagline "make IT visible" underneath in a smaller font. Above and to the right of the name is a stylized, curved graphic in blue and gray, adding a modern touch to the overall design.

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 chanqe 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 Expedition 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 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 imaqe 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.

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Image /page/6/Picture/1 description: The image shows the logo for Prexion. The logo features the name "PreXion" in a light gray, elegant font, with the tagline "make IT visible" underneath in a smaller, blue font. Above and behind the name is a stylized graphic of two curved lines, one in blue and one in gray, creating a sense of movement or technology.

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 Expedition 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 PreXion 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 | Reference Device | | |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Manufacturer | PreXion<br>Corporation | PreXion<br>Corporation | PreXion<br>Corporation | Comparison<br>to Predicate | |
| Trade Name | PreXion3D<br>Expedition | PreXion3D<br>Explorer PRO | PreXion3D<br>Excelsior | | |
| 510(k) Number | K222150 | K203784 | K181983 | N/A | |
| Product Code | OAS | Same | Same | Same | |
| Regulation Number | OAS: 21 CFR<br>892.1750 | Same | Same | Same | |
| Regulation Name | OAS: Computed<br>tomography x-ray<br>system | Same | Same | Same | |
| Device Classification<br>Name | X-Ray, Tomography,<br>Computed, Dental | Same | Same | Same | |
| | PreXion3D Expedition<br>is intended to<br>produce two-<br>dimensional digital x-<br>ray images including<br>panoramic and<br>cephalometric image,<br>and three-<br>dimensional digital x-<br>ray images of the<br>dental, oral,<br>maxillofacial region,<br>ENT (Ear, Nose and<br>Throat) and neck<br>region at the<br>direction of<br>healthcare<br>professionals as<br>diagnostic support for<br>adult and pediatric<br>patients.<br>Cephalometric<br>imaging also includes<br>the hand and wrist to<br>obtain carpus images<br>for growth and<br>maturity assessment.<br>This device is not<br>intended for use on<br>patients less than<br>approximately 21 kg<br>(46 lb) in weight and<br>113 cm (44.5 in) in<br>height; these height<br>and weight<br>measurements<br>approximately<br>correspond to that of<br>an average 5 year<br>old. | PreXion3D Explorer<br>PRO is intended to<br>produce two<br>dimensional digital<br>panoramic and<br>cephalometric<br>images, and three-<br>dimensional digital<br>x-ray images of the<br>maxillofacial, and<br>ENT (Ear, Nose and<br>Throat) and neck<br>region at the<br>direction of<br>healthcare<br>professionals as<br>diagnostic support<br>for adult and<br>pediatric patients.<br>Cephalometric<br>imaging also<br>includes the hand<br>and wrist to obtain<br>carpus images for<br>growth and<br>maturity<br>assessment.<br>This device is not<br>intended for use on<br>patients less than<br>approximately 21<br>kg (46 lb) in weight<br>and 113 cm (44.5<br>in) in height; these<br>height and weight<br>measurements<br>approximately<br>correspond to that<br>of an average 5<br>year old. | PreXion3D Excelsior<br>is intended to<br>produce two-<br>dimensional digital x-<br>ray images including<br>panoramic and<br>cephalometric<br>images, and three-<br>dimensional digital x-<br>ray images of the<br>dental (oral),<br>maxillofacial, and<br>ENT (Ear, Nose and<br>Throat) region at the<br>direction of<br>healthcare<br>professionals as<br>diagnostic support for<br>adult and pediatric<br>patients.<br>Cephalometric<br>imaging also includes<br>the hand and wrist to<br>obtain carpus images<br>for growth and<br>maturity assessment.<br>This device is not<br>intended for use on<br>patients less than<br>approximately 21 kg<br>(46 lb) in weight and<br>113 cm (44.5 in) in<br>height; these height<br>and weight<br>measurements<br>approximately<br>correspond to that of<br>an average 5 year old. | Same | |
| Indications for use: | Patient/User Characteristics | | | | |
| Target Population | Children aged 6<br>(except infants) to<br>elderly | Same | Same | Same | |
| Anatomical Site | The dental, oral,<br>maxillofacial region<br>ENT (Ear, Nose and<br>Throat) and neck<br>region | Same | Same | Same | |
| Users | Health care<br>professionals | Same | Same | Same | |
| | Technological Characteristics and Performance | | | | |
| Patient Contact<br>Material | | CHIN REST:<br>polycarbonate<br>Forehead Holder:<br>silicone rubber<br>HANDLE GRIP:<br>silicone rubber | Same | CHINREST:<br>polycarbonate<br>Forehead Holder:<br>silicone rubber | Same |
| Sterility | | Non-sterile | Same | Same | Same |
| X-ray<br>Generati<br>on<br>Device | Tube<br>Voltage | 90-110KV | Same | 60-110KV | Same |
| | Pulse<br>Exposure<br>function | Yes | Same | Same | Same |
| | Tube<br>Current | 1-5.3mA | Same | 1-6mA | Same |
| | Focal<br>Spot Size | 0.3mm x 0.3mm | Same | Same | Same |
| | | | | | |
| X-ray<br>Image<br>Capturin<br>g Device<br>(CT,<br>Panoram<br>a) | Detector | FPD (TFT) | Same | Same | Same |
| | Photo<br>Diode | IGZO TFT matrix | TFT:a-<br>Si(Amorphous<br>Silicon) | TFT:a-Si | Different |
| | scintillat<br>or | Csl:Tl…