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 Description

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).

AI/ML Overview

This document is a 510(k) Summary for the PreXion3D Explorer EX, a Computed Tomography X-ray System. It describes the device, its intended use, and its substantial equivalence to a predicate device (PreXion3D Explorer, K190320) and a reference device (PreXion3D Excelsior, K181983).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" in the sense of specific performance metrics that the device had to achieve for clearance. Instead, it details modifications to a predicate device and then states that system tests and imaging performance tests were conducted to confirm the validity and diagnostic quality of these modifications, ensuring compliance with relevant standards.

The closest to "acceptance criteria" are the standards the device complies with, and the "reported device performance" is the confirmation that it passed these tests or was deemed equivalent.

Feature / Aspect	Acceptance Criteria (Implicit from Standards/Confirmation)	Reported Device Performance (as stated in the document)
Biocompatibility	Safe materials (ISO 10993-1, -5, -10)	Confirmed safe, uses same materials as marketed device (PreXion3D Excelsior). Passed relevant ISO standards.
Touch Panel/Mirror	Not affecting product safety and performance; electrical safety (IEC60601-1); acceptable risk management for mirror.	IEC60601-1 test performed by qualified lab; risk management performed and mirror decided acceptable.
Modified FOV (15 x 8 to 15 x 10)	Validity of new FOV.	System test performed to confirm validity.
Added FOV (10 x 10)	Validity of new FOV.	System test performed to confirm validity.
Added Panoramic Scan Function	Compliance with imaging performance standard (IEC61223-3-4).	Imaging performance test performed and confirmed to comply with IEC61223-3-4.
Detector's effective area change (smaller by 1.5mm)	Retention of diagnostic quality.	An American board-certified radiologist confirmed diagnostic quality.
Disabled Cephalometric Scan Function	System validity with this function disabled.	System test performed to confirm validity.
General Safety (Electrical, Electromagnetic, Radiation, Usability, Software, etc.)	Compliance with various IEC, ANSI/AAMI, ISO, and NEMA standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 62366-1, IEC 62304, ISO 14971, NEMA PS 3.1 - 3.20).	Passed all testing in accordance with internal requirements, national standards, and international standards.
Cybersecurity	Collect cybersecurity information and report breaches.	No cyber security threat found as of Oct 2019; no cyber breach reported by customers of predicate device as of Nov 2019.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document focuses on non-clinical performance data and a "substantial equivalence" argument rather than clinical or AI algorithm performance studies with defined test sets.

Sample size: Not applicable in the context of typical AI algorithm test sets. The "sample" referred to here are individual modifications to the device and the associated technical tests.
Data provenance: Not explicitly stated as "data provenance" for a test set. The document refers to internal requirements and compliance with international/national standards, suggesting in-house testing or third-party laboratory testing. The radiologist who confirmed diagnostic quality for the detector change is described as "American board-certified," implying a U.S. context for that specific assessment. The cybersecurity information for the predicate device mentions six units installed in the US.
Retrospective or prospective: Not applicable. These are verification and validation activities for device modifications, not a study on an AI algorithm's performance on a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Only one expert is explicitly mentioned for a specific aspect:

Number of experts: One.
Qualifications: "An American board-certified radiologist." No information on years of experience is provided.
Role: Confirmed that images with the detector modification retained "diagnostic quality." This serves as a form of expert assessment for a specific technical change, rather than establishing ground truth for a test set in an AI study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The document describes engineering and performance tests for hardware and software modifications, not a review of clinical cases by multiple experts. The single expert review mentioned for the detector change does not involve an adjudication method as there wasn't a panel.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The device is a Computed Tomography (CT) X-ray system, not an AI-powered diagnostic aide. The document only references "diagnostic support" as the general purpose of the imaging system. There is no mention of AI capabilities or human reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an imaging system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the specific point where an expert was involved (detector's effective area change), the "ground truth" was the expert opinion of an American board-certified radiologist confirming "diagnostic quality." This is not a clinical ground truth like pathology for specific disease detection but an assessment of image quality for diagnostic purposes. For other technical aspects, the "ground truth" was primarily compliance with established national and international standards.

8. The sample size for the training set

Not applicable. The document describes a medical imaging device (hardware and software), not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned for an AI algorithm.

Summary

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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

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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,

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

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Indications for Use

510(k) Number (if known) K193329

Device Name PreXion3D Explorer EX

Indications for Use (Describe)

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

☑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 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

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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

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.

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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

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)
1. To modify middle size FOV: From "15 x 8" to "15 x 10"
1. To add middle size FOV: 10 x 10
1. 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.
1. 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.

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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 ExplorerEX	PreXion3D Explorer	PreXion3D Excelsior	on toPredicate
510(k) Number	K193329/S001	K190320	K181983	N/A
Product Code	OAS	OAS	OAS	Same
Regulation Number	OAS: 21 CFR892.1750	OAS: 21 CFR 892.1750	OAS: 21 CFR 892.1750	Same
Regulation Name	OAS: Computedtomography x-raysystem	OAS: Computedtomography x-ray system	OAS: Computedtomography x-raysystem	Same
Device ClassificationName	X-Ray, Tomography,Computed, Dental	X-Ray, Tomography,Computed, Dental	X-Ray, Tomography,Computed, Dental	Same
Indications for use:	PreXion3D ExplorerEX is intended toproduce two-dimensional digital x-ray images includingpanoramic image, andthree-dimensionaldigital x-ray images ofthe dental, oral,maxillofacial region,ENT (Ear, Nose andThroat) and neck regionat the direction ofhealthcare professionalsas diagnostic supportfor adult and pediatricpatients.This device is notintended for use onpatients less thanapproximately 21 kg(46 lb) in weight and113 cm (44.5 in) inheight; these height and	PreXion3D Explorer isintended to produce two-dimensional digital x-rayimages includingpanoramic andcephalometric image, andthree-dimensional digitalx-ray images of the dental,oral, maxillofacial region,ENT (Ear, Nose andThroat) and neck region atthe direction of healthcareprofessionals as diagnosticsupport for adult andpediatric patients.Cephalometric imagingalso includes the hand andwrist to obtain carpusimages for growth andmaturity assessment.	PreXion3D Excelsior isintended to produce twodimensional digitalpanoramic andcephalometric images,and three-dimensionaldigital x-ray images ofthe dental(oral).maxillofacial, and ENT(Ear, Nose and Throat)region at the directionof healthcareprofessionals asdiagnostic support foradult and pediatricpatients. Cephalometricimaging also includesthe hand and wrist toobtain carpus imagesfor growth and maturityassessment	CephalometricScanFunction isdisabled bythe consolesoftware.Otherwiseequivalent

Table-6A: Comparison of Characteristics

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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:polycarbonateForehead Holder:silicone rubberHANDLE GRIP:silicone rubber	CHINREST:polycarbonateHEADREST: carbonBELT: polyvinyl chloride	CHIN REST:polycarbonateForehead Holder:silicone rubberHANDLE GRIP:silicone rubber	Same materials are used
Material
Sterility			Non-sterile	Non-sterile	Non-sterile	Same
X-rayGenerationDevice	TubeVoltage		90-110KV	90-110KV	60-110KV	Same or Equivalent
	PulseExposurefunction		Yes	Yes	Yes	Same
	TubeCurrent		1-5mA	1-3mA	1-6mA	Tube Current is similar.Added according with Panoramic
	FocalSpot 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
	PixelSize	248 µm x248µm (Withbinning)(CT, CT-Panoramic,Panoramic)124 µm x124µm(Without binning)(CT, CT-Panoramic,Panoramic)	248 µm x248µm (Withbinning)(CT, CT-Panoramic,Ceph)124 µm x124µm (Withoutbinning)(CT, CT-Panoramic,Ceph)	250 µm x250µm (Withbinning)(CT, CT-Panoramic.Panoramic)125 µm x125µm(Without binning)(CT, CT-Panoramic)125µm x 125µm(Panoramic)140 µm x 140µm(Ceph)	Equivalent
X-rayImageCapturing Device	PixelNumber	1024x1280(Withbinning)(CT, CT-Panoramic)2560x2048(Withoutbinning)(CT, CT-Panoramic)1900 x 120(Panoramic)	1024x1280(With binning)(CT, CT-Panoramic)2560x2048(Withoutbinning)(CT, CT-Panoramic,Ceph)1024x1280(With binning)	1024x1280 (CT)128x128 (Panoramic)2112x1754(Cephalometric)	ComparingtoK190320,Deviceis
	Size ofAreaReceiving 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, justthe use ischanged sothat Ceph isdisabledandPanoramicScanisadded.
	Numberof Bits	16bits (CT, CT-Panoramic, Panoramic)	16bits (CT, CT-Panoramic, Ceph)	16bits (CT, CT-Panoramic, Panoramic)14bits (Ceph)
Scanner	SID/SOD	700mm/ 420mm (CT,CT-Panoramic.Panoramic)	700mm/ 420mm (CT, CT-Panoramic, Ceph)	700mm/ 470mm (CT,Panoramic)1735mm / 1500mm(Ceph)	ComparingtoK190320, Device issame, justthe use ischanged sothat Ceph isdisabledandPanoramicScanisadded.
	Dimension(WxDxH)	880 mm x 1237 mm x2268 mm (CT, CT-Panoramic, Panoramic)	880 mm x 1237 mm x2268 mm (CT, CT-Panoramic, Ceph)	930 mm x 1230 mm x2220 mm (CT, CT-Panoramic, Panoramic)1816 mm x 1230 mm x	K190320, geometryis 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, Panoramicscan	CT scan, CT-Panoramic,Cephalometricradiography	CT scan, CT-Panoramic, Panoramicscan,Cephalometricradiography	NoCephalometricRadiographyAddedPanoramicscan(IdenticaltoK181983)
Panoramic ScanPerformance (ScanTime)		8-16sec	18sec	8-16sec	Scan Timeisimprovedor same.
CephalometricRadiography (ScanTime)		N/A	0.16 sec	0.5-0.8 sec	NoCephalometricRadiography
CT ScanPerformance	ScanTime	10-20sec	10-20sec	5.2-23.6sec	Same orSimilar
	FOV(VoxelSize)	Diameter 150mm xH156mm (0.100 -0.200mm)Diameter 150mm xH100mm (0.100 -0.200mm)	Diameter 150mm xH156mm (0.100 -0.200mm)Diameter 150mm xH78mm (0.100 -0.200mm)	Diameter 150mm xH130mm(0.100 - 0.200mm)Diameter 150mm x H81(0.200mm)Diameter 100mm xH81mm (0.100 -0.200mm)	Added onemiddle sizeFOV andgets biggerin middlesize FOVfor userrequirement.
		Diameter 100mm xH100mm (0.100 -0.200mm)Diameter 50mm xH50mm(0.100 - 0.200mm)	Diameter 50mm x H50mm(0.100 - 0.200mm)	Diameter 100mm xH50mm (0.100 -0.200mm)Diameter 50mm xH50mm (0.100 -0.200mm)

Spatial Resolution		Standard mode:50%MTF: 0.95LP/mm20%MTF:2.0LP/mmRapid Mode:50%MTF: 0.95LP/mm20%MTF:2.0LP/mm	Standard mode:50%MTF: 0.95LP/mm20%MTF:2.0LP/mmRapid Mode:50%MTF: 0.95LP/mm20%MTF:2.0LP/mm	Standard mode50%MTF: 1.2LP/mm20%MTF:2.3LP/mmRapid Mode50%MTF: 1.2LP/mm20%MTF:2.3LP/mm	Same orequivalent

		High Resolution mode:	High Resolution mode:	High Resolution mode:

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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.

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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.

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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/mm20%MTF:2.0LP/mm	50%MTF: 0.95LP/mm20%MTF:2.0LP/mm	50%MTF: 1.2LP/mm20%MTF:2.3LP/mm
	High contrast mode:50%MTF: 0.95LP/mm20%MTF:2.0LP/mm	High contrast mode:50%MTF: 0.95LP/mm20%MTF:2.0LP/mm	High contrast mode:50%MTF: 1.2LP/mm20%MTF:2.3LP/mm
Viewer Software(Image AnalysisSystem Software)	Display High-resolution 2D and 3DImages FunctionImage ProcessingFunction includesAirway measurementImage OperationFunctionOutput Function	Display High-resolution2D and 3D ImagesFunctionImage Processing Functioninclude AirwaymeasurementImage Operation FunctionOutput Function	Display High-resolution2D and 3D ImagesFunctionImage ProcessingFunction include AirwaymeasurementImage OperationFunctionOutput Function	Same
Console SoftwareSystem Settings	CT Scaninclude CT-Panoramicmode	CT Scaninclude CT-Panoramicmode	CT Scaninclude CT-Panoramicmode	Same
Applied Standard
Electrical SafetyStandard	ANSI/AAMI ES60601-1	ANSI/AAMI ES60601-1	ANSI/AAMI ES60601-1
ElectromagneticCompatibilityStandard	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2
Radiation SafetyStandard	IEC 60601-1-3	IEC 60601-1-3	IEC 60601-1-3
ElectricalEquipment UsabilitySafety Standard	IEC 60601-1-6	IEC 60601-1-6	IEC 60601-1-6
UsabilityEngineeringStandard	IEC 62366 -1	IEC 62366	IEC 62366
Software LifecycleProcess Standard	IEC 62304	IEC 62304	IEC 62304	Same
Essentialperformance ofdental extra-oral X-ray equipmentStandard	IEC 60601-2-63	IEC 60601-2-63	IEC 60601-2-63
Acceptance tests ofImagingperformance ofdental X-rayequipment Standard	IEC 61223-3-4	IEC 61223-3-4	IEC 61223-3-4
Acceptance tests ofImagingperformance ofcomputedtomography X-rayequipment Standard	IEC 61223-3-5	IEC 61223-3-5	IEC 61223-3-5
Laser SafetyStandard	IEC 60825-1	IEC 60825-1	IEC 60825-1
Risk ManagementStandard	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
BiocompatibilityStandardCompliance	ISO 10993-1	ISO 10993-1	ISO 10993-1
BiocompatibilityStandardCompliance	ISO 10993-5	ISO 10993-5	ISO 10993-5
BiocompatibilityStandardCompliance	ISO 10993-10	ISO 10993-10	ISO 10993-10

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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.
1. 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.
1. 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.
1. To add middle size FOV: 10 x 10
  System test was performed to confirm that 10 x 10 of middle size FOV is valid.
1. 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.
1. 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.

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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.

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.

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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. Collect cybersecurity information from the link described in Post-market Plan
  As of October, 2019, there is no cyber security thread by PreXion's investigation.
1. Collect information if there is any cyber security breach at customer site.
  As of November 11th, 2019, six PreXion3D Explorer (Predicate Device) have been installed in the US and no cyber breach is reported by the customer.

12. 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 EX, 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.