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.

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.

AI/ML Overview

This FDA 510(k) summary does not contain information about an AI/ML-based medical device. Instead, it describes a Computed Tomography X-Ray System (PreXion3D Explorer PRO) which is a hardware device used for generating X-ray images, and the accompanying software primarily performs image analysis and reconstruction, not AI-driven diagnostic assistance.

Therefore, the requested information regarding acceptance criteria and study proving device meets acceptance criteria, including details about sample sizes, expert qualifications, ground truth establishment, MRMC studies, and standalone performance for an AI/ML-based system, cannot be extracted from the provided text.

The document details the technical specifications of the PreXion3D Explorer PRO and compares it to a predicate device (an earlier model of the same product). The performance data mentioned are non-clinical hardware and software verification tests against established standards (e.g., electrical safety, electromagnetic compatibility, radiation safety, software verification and validation, biocompatibility), not clinical performance data related to diagnostic accuracy validated through expert reads or ground truth.

Summary of what is present:

Device: PreXion3D Explorer PRO, a Computed Tomography X-Ray System.
Purpose: Produces 2D (panoramic, cephalometric) and 3D (CT) digital x-ray images of dental, oral, maxillofacial, ENT, and neck regions for diagnostic support.
Predicate Device: PreXion3D Explorer PRO (Model: P03A), K203784.
Evidence for Substantial Equivalence: Primarily non-clinical performance data demonstrating compliance with various national and international standards (e.g., IEC 60601 series, ISO 10993 series, IEC 62304 for software).
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." This explicitly states that no clinical studies were performed for this submission to prove performance against specific diagnostic objectives, as it relies on the predicate's established safety and efficacy.

Information NOT present (and therefore cannot be provided as requested):

Acceptance criteria related to AI/ML diagnostic performance (e.g., sensitivity, specificity, AUC).
Any details about a study demonstrating the device meets such AI/ML performance acceptance criteria.
Sample sizes for test sets where ground truth for AI performance is established.
Data provenance for AI/ML test sets.
Number/qualifications of experts for ground truth establishment.
Adjudication methods.
MRMC comparative effectiveness study results or effect sizes for human readers with/without AI assistance.
Standalone (algorithm-only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for AI/ML training set.
How ground truth for an AI/ML training set was established.

Summary

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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

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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 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

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Indications for Use

510(k) Number (if known) K221525

Device Name PreXion3D Explorer PRO

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 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

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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

7. Device Description

The operating principle of the device is as follows.

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 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.

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.

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.

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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	Comparisonto Predicate
Trade Name	PreXion3D ExplorerPRO	PreXion3D ExplorerPRO
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: Computedtomography x-raysystem	OAS: Computedtomography x-raysystem	Same
Device ClassificationName	X-Ray, Tomography,Computed, Dental	X-Ray, Tomography,Computed, Dental	Same
PreXion3D Explorer PRO
Indications for use:	PreXion3D Explorer PROis intended to producetwo dimensional digitalpanoramic andcephalometric images,and three-dimensionaldigital x-ray images ofthe maxillofacial, andENT (Ear, Nose andThroat) and neck regionat the direction ofhealthcare professionalsas diagnostic support foradult and pediatricpatients.Cephalometric imagingalso includes the handand wrist to obtaincarpus images forgrowth and maturityassessment.This device is notintended for use onpatients less thanapproximately 21 kg (46lb) in weight and 113 cm(44.5 in) in height; theseheight and weightmeasurementsapproximatelycorrespond to that of anaverage 5 year old.	PreXion3D Explorer PROis intended to producetwo dimensional digitalpanoramic andcephalometric images,and three-dimensionaldigital x-ray images ofthe maxillofacial, andENT (Ear, Nose andThroat) and neck regionat the direction ofhealthcare professionalsas diagnostic support foradult and pediatricpatients.Cephalometric imagingalso includes the handand wrist to obtaincarpus images forgrowth and maturityassessment.This device is notintended for use onpatients less thanapproximately 21 kg (46lb) in weight and 113 cm(44.5 in) in height; theseheight and weightmeasurementsapproximatelycorrespond to that of anaverage 5 year old.	Same
Patient/UserCharacteristics
Target Population	Children aged 6 (exceptinfants) to elderly	Children aged 6 (exceptinfants) to elderly	Same
Anatomical Site	The dental, oral,maxillofacial regionENT (Ear, Nose andThroat) and neck region	The dental, oral,maxillofacial regionENT (Ear, Nose andThroat) and neck region	Same
Users	Health careprofessionals	Health careprofessionals	Same
TechnologicalCharacteristics andPerformance
Patient ContactMaterial	CHIN REST:polycarbonateForehead Holder:silicone rubberHANDLE GRIP:silicone rubber	CHIN REST:polycarbonateForehead Holder:silicone rubberHANDLE GRIP:silicone rubber	Same
Sterility	Non-sterile	Non-sterile	Same
X-rayGenerationDevice	TubeVoltage	90-110KV	90-110KV	Same
	PulseExposurefunction	Yes	Yes	Same
	TubeCurrent	1-5.3mA	1-5.3mA	Same
	Focal SpotSize	0.3mm x 0.3mm	0.3mm x 0.3mm	Same
Collimator Size		CT scan (Face) /CT-Panorama Scan (Face):33.6mm x 27mmCT scan (Arch): 20.6mmx 20.8mmCT scan (Full): 23mm x27mmCT scan (Teeth) :10.5mm x 10.2mmPanoramic Scan: 1mm x24.2mmCephalometric Exposure:22.0mm x 17.6mm	CT scan (Face) /CT-Panorama Scan (Face):SameCT scan (Arch): SameCT scan (Full): SameCT scan (Teeth): SamePanoramic Scan: SameCephalometric Exposure:23.6mm x 18.7mm	Similar(Same exceptforCephalometricExposure)
	Detector	FPD (TFT)	FPD (TFT)	Same
X-rayImageCapturing Device	Pixel Size	248 µm x248µm (Withbinning)(CT, CT-Panoramic,Panoramic)124 µm x124µm(Without binning)(CT, CT-Panoramic,Panoramic, Ceph)	248 µm x248µm (Withbinning)(CT, CT-Panoramic,Panoramic)124 µm x124µm(Without binning)(CT, CT-Panoramic,Panoramic, Ceph)	Same
	PixelNumber	1024x1280(Withbinning)(CT, CT-Panoramic)	1024x1280(Withbinning)(CT, CT-Panoramic)	Same
		2560x2048 (Withoutbinning)(CT, CT-Panoramic,Ceph)	2560x2048 (Withoutbinning)(CT, CT-Panoramic,Ceph)	Same
		1900 x 120(Panoramic)	1900 x 120(Panoramic)	Same
		2560 x 2048(Cephalometric)	2560 x 2048(Cephalometric)	Same
	Size ofAreaReceivingX-ray	253.95mm x 317.44mm(CT, CT-Panoramic)230mm x 15mm(Panoramic)	253.95mm x 317.44mm(CT, CT-Panoramic)230mm x 15mm(Panoramic)	Same
				Image: Prexion3D logo with text "make IT visible"
		239mm x 302mm(Ceph)	253.95mm x 317.44mm(Ceph)	Smaller
	Number ofBits	16bits (CT, Panorama, Ceph)	16bits (CT, Panorama, Ceph)	Same
Scanner	SID/SOD	700mm/ 420mm (CT, CT-Panoramic, Panoramic)1000mm / 840mm (Ceph)	700mm/ 420mm (CT, CT-Panoramic, Panoramic)1000mm / 840mm (Ceph)	Same
	Dimension(WxDxH)	1,112 mm x 1,558 mm x 2330 mm (CT, CT-Panoramic, Panoramic)1164 mm x 1690 mm x 2330 mm (with Ceph)	1,112 mm x 1,558 mm x 2330 mm (CT, CT-Panoramic, Panoramic)1164 mm x 1690 mm x 2330 mm (with Ceph)	Same
	Weight	230 kg (CT, CT-Panoramic, Panoramic, Ceph)	230 kg (CT, CT-Panoramic, Panoramic, Ceph)	Same
Imaging Mode		CT scan, CT-Panoramic, Panoramic scan, Cephalometric radiography	CT scan, CT-Panoramic, Panoramic scan, Cephalometric radiography	Same
Panoramic ScanPerformance (ScanTime)		8-16sec	8-16sec	Same
CephalometricRadiography (ScanTime)		0.16sec	0.16sec	Same
	Scan Time	10-20sec	10-20sec	Same
CT ScanPerformance	FOV(VoxelSize)	Diameter 150mm x H156mm (0.100 - 0.200mm)	Diameter 150mm x H156mm (0.100 - 0.200mm)	Same
		Diameter 150mm x H100mm (0.100 - 0.200mm)Diameter 100mm x H100mm (0.100 - 0.200mm)Diameter 50mm x H50mm(0.100 - 0.200mm)	Diameter 150mm x H100mm (0.100 - 0.200mm)Diameter 100mm x H100mm (0.100 - 0.200mm)Diameter 50mm x H50mm(0.100 - 0.200mm)	Same
Xion3D Explorer PRO			Image: PreXion logo
ElectromagneticCompatibilityStandard	IEC 60601-1-2	IEC 60601-1-2
Radiation SafetyStandard	IEC 60601-1-3	IEC 60601-1-3
Electrical EquipmentUsability SafetyStandard	IEC 60601-1-6	IEC 60601-1-6
Usability EngineeringStandard	IEC 62366	IEC 62366
Software LifecycleProcess Standard	IEC 62304	IEC 62304
Essentialperformance ofdental extra-oral X-ray equipmentStandard	IEC 60601-2-63	IEC 60601-2-63
Acceptance tests ofImaging performanceof dental X-rayequipment Standard	IEC 61223-3-4	IEC 61223-3-4
Acceptance tests ofImaging performanceof computedtomography X-rayequipment Standard	IEC 61223-3-5	IEC 61223-3-5
Laser SafetyStandard	IEC 60825-1	IEC 60825-1
Risk ManagementStandard	ISO 14971	ISO 14971
DICOM Standard	NEMA PS 3.1 - 3.20	NEMA PS 3.1 - 3.20
BiocompatibilityStandard Compliance	ISO 10993-1	ISO 10993-1
BiocompatibilityStandard Compliance	ISO 10993-5	ISO 10993-5
BiocompatibilityStandard Compliance	ISO 10993-10	ISO 10993-10

Table 5A - Comparison of Characteristics

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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 stylized font, with the "Pre" in a lighter shade of gray and the "Xion" in a darker shade of gray. Below the company name is the tagline "make IT visible" in a smaller font. Above the company name is a blue swoosh design.

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PreXion Corporation PreXion3D Explorer PRO

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 "Xion" portion of the name in a lighter shade of gray. 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 and gray swoosh design.

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PreXion Corporation

PreXion3D Explorer PRO

Image /page/9/Picture/1 description: The image shows the logo for Prexion. The logo is in a light gray color, and the tagline "make IT visible" is in a smaller font below the name. A blue swoosh design is above and behind the name, adding a modern and dynamic element to the logo.

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PreXion Corporation Prex

9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of PreXion3D Explorer PRO and in showing substantial equivalence to the predicate device, PreXion Corporation completed a number of nonclinical performance tests. The PreXion3D Explorer PRO 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.

The PreXion3D Explorer PRO passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

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Image /page/11/Picture/1 description: The image contains the logo for PreXion. The logo features the company name in a stylized font, with the words "make IT visible" underneath. A blue and gray swoosh design appears above and behind the company name, adding a modern and dynamic element to the logo.

Biocompatibility testing per ISO 10993-1, ISO 10993-5 and ISO 10993-10 ●
Electrical safety testing per ANSI/AAMI ES 60601-1, IEC 60601-1-3 and IEC 60601-1-6 .
Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2
. Dental extra-oral X-ray equipment testing per IEC 60601-2-63
. Software verification and validation IEC 62304
Acceptance testing of X-ray equipment per IEC 61223-3-4 and IEC 61223-3-5
Storage and Transport Testing per ISO 4180
IEC 62366-1:2015 Usability engineering to medical devices
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 use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11.Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).

The PreXon3D Explorer PRO, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.