Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image processing and reconstruction techniques for CT and panoramic images. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data. The performance studies focus on traditional non-clinical and clinical equivalence testing, not AI/ML model validation.

Therapeutic

No.
The device is used for diagnostic imaging (producing X-ray images) and not for treating a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended to produce images "as diagnostic support".

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a "scanner" (hardware for generating and detecting X-rays) and a "Console" (hardware for operating the scanner and managing data), in addition to the software for image analysis. This indicates it is a hardware-software system, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The PreXion3D Explorer EX is an imaging device that uses X-rays to create images of the dental, oral, maxillofacial, ENT, and neck regions. It does not analyze samples taken from the body.
Intended Use: The intended use is to produce digital x-ray images as diagnostic support, which is a function of medical imaging devices, not IVDs.
Device Description: The description details the process of generating and detecting X-rays and reconstructing images, which is consistent with an imaging device.

Therefore, the PreXion3D Explorer EX falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

OAS

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).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography X-ray

Anatomical Site

dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region

Indicated Patient Age Range

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.

Intended User / Care Setting

Health care professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance tests were conducted to demonstrate safety and effectiveness and substantial equivalence to the predicate device.
Summary of performance testing performed for each modification stated in Section 7:

To apply Chinrest/Forehead Holder which are used in PreXion3D Excelsior (K181983): Biocompatibility is safe because same materials as to marketed device are used.
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 an outside test lab qualified with ISO17025. Risk management was performed regarding the added mirror and decided it's acceptable.
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.
To add middle size FOV: 10 x 10: System test was performed to confirm that 10 x 10 of middle size FOV is valid.
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.
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.
To disable Cephalometric Scan Function by replacing the console software: 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, including:

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".
Solid State X-ray Imaging (SSXI) equivalence 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".

No human clinical testing was required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K190320

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K181983

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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)

☑Prescription Use (Part 21 CFR 801 Subpart D)	☐Over-The-Counter Use (21 CFR 801 Subpart C)
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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

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

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.

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

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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:
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)

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

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.
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.

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.

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. 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.