Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing and reconstruction techniques for CT and X-ray data. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.

Therapeutic

No.
The device is used for diagnostic imaging, not for treating any condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is intended to produce digital x-ray images "as diagnostic support."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device consists of a scanner (hardware for generating X-ray and detecting image data) and a Console (hardware for operating the scanner and managing data). The performance studies also include testing related to hardware components like electrical safety, electromagnetic safety, and X-ray equipment testing.

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 medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
Device Function: The PreXion3D Explorer is an X-ray imaging system. It generates X-rays that pass through the patient's body to create images for diagnostic support. This process is performed inside the body (in vivo).
Intended Use: The intended use is to produce digital X-ray images of specific anatomical regions for diagnostic support. This involves capturing images of the patient's internal structures, not analyzing samples taken from the patient.

Therefore, the PreXion3D Explorer 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 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.

Product codes

OAS

Device Description

PreXion3D Explorer 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.

X-ray image data is acquired while the rotation 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 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.

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) 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).

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

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

Indicated Patient Age Range

adult and pediatric patients.

Intended User / Care Setting

healthcare 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 Data:
PreXion Corporation completed a number of non-clinical tests to demonstrate safety and effectiveness and substantial equivalence. The PreXion3D Explorer meets all the requirements for overall design, performance, biocompatibility, and electrical safety, confirming that the design output meets the design inputs and specifications for the device.

The PreXion3D Explorer passed all 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

Clinical Performance Data:
No human clinical testing was required as the indications for use are 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. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

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

Not Found

Predicate Device(s)

K181983

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 15, 2019

PreXion Corporation % Hiroaki Takahashi General Manager, Quality Assurance & Regulatory Division 1-14-1, Kanda Suda-cho Chiyoda-ku, Tokyo101-0041 JAPAN

Re: K190320

Trade/Device Name: PreXion3D Explorer Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: February 8, 2019 Received: February 13, 2019

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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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 and to the right of the text is a curved, blue and gray graphic element, adding a modern and technological feel to the logo.

Section 5 – 510(k) Summary

Device Name: PreXion3D Explorer

K190320

1. Submission Sponsor

PreXion Corporation 1-14-1, Kanda Suda-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

February 8th, 2019

4. Device Identification

Trade/Proprietary Name:	PreXion3D Explorer
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

4

Image /page/4/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" portion in a light gray color and the "Xion" portion in a darker gray. Above the "Xion" part of the name is a blue swoosh design. Below the company name is the tagline "make IT visible" in a smaller font.

5. Legally Marketed Predicate Device(s)

K181983, PreXion3D Excelsior, PreXion Corporation

6. Indication for Use Statement

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.

7. Device Description

PreXion3D Explorer 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.

X-ray image data is acquired while the rotation 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 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.

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) applied to the X-ray tube brings the following features.

5

Image /page/5/Picture/1 description: The image shows the logo for PreXion. The logo features the company name in a stylized font, with the word "Pre" in a lighter shade of gray and "Xion" in a darker shade. Below the company name is the tagline "make IT visible" in a smaller font. Above the company name is a blue swoosh design that adds a modern and dynamic element to the logo.

· 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).

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.

8. Substantial Equivalence Discussion

The following table compares the PreXion3D Explorer 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.

Manufacturer	PreXion Corporation	PreXion Corporation
Trade Name	PreXion3D Explorer	PreXion3D Excelsior	Comparison to
Predicate
510(k) Number	TBD	K181983	N/A
Product Code	OAS	OAS	Same
Regulation Number	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	Same

Device Classification
Name		X-Ray, Tomography, Computed,
Dental	X-Ray, Tomography, Computed,
Dental	Same
Indications for use:		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.	PreXion 3D 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.	Minor wording
differences do
not raise any
additional
questions of
safety or
efficacy.

Target Population		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	Same
Users		Health care professionals	Health care professionals	Same
	Technological Characteristics and Performance
Patient Contact Material		CHIN REST: polycarbonate
HEAD SUPPORT: carbon
HANDLE GRIP: silicone rubber	CHIN REST: polycarbonate
HEADREST: silicone rubber
BELT: polyvinyl chloride	Biocompatibility
test results
support that the
material is safe
for the intended
use.
Sterility		Non-sterile	Non-sterile	Same
X-ray
Generation
Device	Tube
Voltage	90-110KV	60-110KV	Applied current
is reduced so
that the dose
level is
equivalent.
	Pulse
Exposure
function	Yes	Yes	Same
	Tube
Current	1-3mA	1-6mA	Applied current
is reduced so
that the dose
level is
equivalent.
	Focal Spot
Size	0.3mm x 0.3mm	0.3mm x 0.3mm	Same
	Detector	FPD (TFT)	FPD (TFT)	Same
X-ray Image
Capturing
Device	Pixel Size	248 μm x248μm (With binning)
(CT, CT-Panoramic, Ceph)	125 μm x125μm,125μm x250μm (CT)
		124 μm x124μm (Without
binning)
(CT, CT-Panoramic, Ceph)	125 μm x 125μm (Panoramic)
			140 μm x 140μm (Ceph)
	Pixel
Number	1024x1280(With binning)
(CT, CT-Panoramic)
2560x2048(Without binning)
(CT, CT-Panoramic, Ceph)	1280x1024 (CT)
128x1280 (Panoramic)
2112x1754 (Cephalometric)	FPD has been
changed and
gets bigger. The
performance
gets better.
	Size of
Area
Receiving
X-ray	253.95mm x 317.44mm
(CT, CT-Panoramic, Ceph)	160mm x 128mm (CT)
160mm x 12.5mm (Panoramic)
295.68 x 245.56mm (Ceph)
	Number
of Bits	16bits (CT, CT-Panorama, Ceph)	16bits (CT, Panorama)
14bits (Ceph)
Scanner	SID/SOD	700mm/ 420mm (CT, CT-
Panoramic, Ceph)	700mm/ 470mm (CT,
Panoramic)
1735mm / 1500mm (Ceph)	Radius of
rotation gets
smaller so that
they are
substantially
equivalent.
	Dimension
(WxDxH)	880 mm x 1237 mm x
2268 mm (CT, CT-Panoramic,
Ceph)	930 mm x 1230 mm x
2220 mm (CT, Panoramic)
1747 mm x 1230 mm x
2220 mm (with Ceph)
	Weight	165 kg (CT, CT-Panoramic, Ceph)	165 kg (CT, Panoramic)
200kg (Ceph)	Cephalo is
integrated, thus,
it gets lighter.
	Imaging Mode	CT scan, CT-Panoramic scan,
Cephalometric radiography	CT scan, Panoramic scan,
Cephalometric radiography	Equivalent
		Panoramic Scan
Performance (Scan Time)	18sec	8-16sec	Irradiance level
is equivalent.
		Cephalometric
Radiography (Scan Time)	0.1 sec	0.5-0.8 sec	Improved
CT Scan
Performance	Scan Time	10-20sec	5.2-25.6sec	Similar
	FOV
(Voxel
Size)	Diameter 150mm x H156mm
(0.100 - 0.200mm)
Diameter 150mm x H78mm
(0.100 - 0.200mm)
Diameter 50mm x H50mm	Diameter 100mm x H81mm
(0.100 - 0.200mm)
Diameter 100mm x H50mm
(0.100 - 0.200mm)
Diameter 50mm x H50mm	FPD gets bigger
so that it can
scan larger
object.

Table-5A: Comparison of Characteristics

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Image /page/6/Picture/1 description: The image contains the logo for PreXion. The logo features the name "PreXion" in a stylized font, with the "IT" in the tagline "make IT visible" in a slightly bolder font. Above and to the right of the name is a blue and white swoosh design, adding a modern and dynamic element to the logo.

7

Image /page/7/Picture/1 description: The image shows the logo for PreXion. The logo features the company name in a light gray, italicized font, with the "IT" in "make IT visible" in blue. Above and behind the name is a curved, swooping graphic that transitions from light blue to white, adding a sense of motion and technology to the overall design.

8

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

	(0.100 - 0.200mm)	(0.100 - 0.200mm)
		Diameter 150mm x H130mm
(0.100 - 0.200mm)
Volume Size	500x500x500
750x750x780	512x512x512
512x512x950
1024x1024x816
1024x1024x1515	Volume Size is
smaller; thus,
the file size gets
smaller.
Dose Level
(CTDIw)	Standard (110KV, 2mA, 10s)
15cm: 1.7mGy
5cm: 0.5mGy

High Definition (110KV, 2.0mA, 18s)
15cm: 3.1mGy
5cm: 0.9mGy

Ultra-High Definition (110KV, 2.0mA, 20s)
15cm: 2.3mGy
5cm: 0.7mGy

Standard Child (90KV, 1mA, 10s)
15cm: 0.5mGy
5cm: 0.1mGy | Standard (110KV, 2.4mA, 9.6s)
10cm: 2.9mGy
5cm: 1.9mGy

Rapid (110KV, 2.4mA, 5.2s)
10cm: 0.9mGy
5cm: 0.8mGy

High Definition (110KV, 2.4mA, 12.8s)
10cm: 4.9mGy
5cm: 3.2mGy

Ultra-High Definition (110KV, 2.4mA, 23.6s)
10cm: 8.7mGy
5cm: 4.3mGy

Standard Child (95KV, 1.6mA, 9.6s)
10cm: 1.4mGy
5cm: 1.0mGy

Rapid Child (95KV, 1.6mA, 5.2s)
10cm: 0.5mGy
5cm: 0.4mGy

Complete (110KV, 2.4mA, 19.2s)
10cm: 5.8mGy

Complete Child (95KV, 1.6mA, 19.2s)
10cm: 2.9mGy | Dose Level is
similar and
improved. |
| Spatial Resolution | Standard mode:
50%MTF: 0.95LP/mm
20%MTF:2.0LP/mm

Rapid Mode:
50%MTF: 0.95LP/mm
20%MTF:2.0LP/mm | Standard mode:
50%MTF: 1.2LP/mm
20%MTF:2.3LP/mm

Rapid Mode:
50%MTF: 1.2LP/mm
20%MTF:2.3LP/mm | Spatial
Resolution is
similar and
improved. |
| | 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: 1.2LP/mm
20%MTF:2.3LP/mm | |
| | Display High-resolution 2D and
3D Images Function | Display High-resolution 2D and
3D Images Function | |
| Viewer Software (Image
Analysis System
Software) | Image Processing Function
includes Airway measurement
Image Operation Function | Image Processing Function
include Airway measurement
Image Operation Function | Same |
| Console Software
System Settings | Output Function
CT Scan
include CT-Panoramic mode | Output Function
CT Scan
include CT-Panoramic mode | Same |
| | Applied Standard | | |
| Electrical Safety Standard | ANSI/AAMI ES60601-1 | ANSI/AAMI ES60601-1 | |
| Electromagnetic
Compatibility Standard | IEC 60601-1-2 | IEC 60601-1-2 | |
| Radiation Safety Standard | IEC 60601-1-3 | IEC 60601-1-3 | |
| Electrical Equipment
Usability Safety Standard | IEC 60601-1-6 | IEC 60601-1-6 | |
| Usability Engineering
Standard | IEC 62366 -1 | IEC 62366 | |
| Software Lifecycle
Process Standard | IEC 62304 | IEC 62304 | |
| Essential performance of
dental extra-oral X-ray
equipment Standard | 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 | Same |
| Acceptance tests of
Imaging performance of
computed tomography X-
ray equipment Standard | IEC 61223-3-5 | IEC 61223-3-5 | |
| Laser Safety Standard | IEC 60825-1 | IEC 60825-1 | |
| Risk Management
Standard | ISO 14971 | ISO 14971 | |
| DICOM Standard | NEMA PS 3.1 - 3.20 | NEMA PS 3.1 - 3.20 | |
| Biocompatibility Standard
Compliance | ISO 10993-1 | ISO 10993-1 | |
| Biocompatibility Standard
Compliance | ISO 10993-5 | ISO 10993-5 | |
| Biocompatibility Standard
Compliance | ISO 10993-10 | ISO 10993-10 | |

9

Image /page/9/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 light gray color and the "Xion" in a darker gray. Below the word "PreXion" is the tagline "make IT visible" in a smaller font. Above and to the right of the word "PreXion" is a blue and white swoosh design.

10

Image /page/10/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" portion in a light gray color and the "xion" portion in a darker gray. 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 swoosh design, which adds a modern and dynamic element to the logo.

9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of PreXion3D Explorer and in showing substantial equivalence to the predicate device, PreXion Corporation completed a number of non-clinical The PreXion3D Explorer meets all the requirements for overall design, performance tests. biocompatibility, performance, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.

The PreXion3D Explorer 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

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.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate 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

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Image /page/11/Picture/1 description: The image shows the logo for PreXion. The logo features the word "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 font. Above and behind the text is a curved, blue graphic element that resembles a stylized eye or lens, with a subtle shadow effect that gives it a three-dimensional appearance.

does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).

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