Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing and reconstruction techniques for X-ray and CT data. There is no mention of AI, ML, or related terms, nor are there descriptions of training or test sets typically associated with AI/ML model development.

Therapeutic

No
The device is an imaging system intended for diagnostic support by producing X-ray images, not for therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device provides "diagnostic support." Additionally, the "Device Description" mentions that the processed data reconstructs "diagnostic images."

SaMD (Software as a Medical Device)

No

The device description explicitly states it 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 software. This indicates it is a hardware and 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 such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
Device Description: The PreXion3D Excelsior is an X-ray imaging system that produces images of the maxillofacial, ENT, and hand/wrist regions. It works by generating X-rays that pass through the patient's body and are detected to create images.
Intended Use: The intended use is to produce images for diagnostic support based on the anatomical structures within the patient's body, not on analysis of samples taken from the body.

The device is a medical imaging device, specifically a type of X-ray system, used for visualizing internal structures. This falls under the category of medical devices, but not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital x-ray images of the 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.

Product codes

OAS

Device Description

PreXion3D Excelsior 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 Excelsior 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.

During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

maxillofacial, and ENT (Ear, Nose and Throat) region, hand and wrist (carpus)

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:

Conformance to non-clinical performance requirements through evaluation and testing in accordance with harmonized standards (listed in the document).
Testing for 3D imaging performance to assess MTF for three image orientations (x, y, z) for the applicable 3D modes of device operation.
Non-clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".
Results: Results of all non-clinical testing and non-clinical considerations support the safety and effectiveness of the subject device.

Clinical Performance Data:

Clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" were performed by qualified clinical assessors.
Results: Results of the clinical consideration support the safety and effectiveness of the subject device.

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

Not Found

Predicate Device(s)

K122199, K103659, K133620

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird design formed by three overlapping profiles of human faces. The faces are oriented to the right and are stacked on top of each other. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3, 2016

PreXion Corporation % Mr. Shumpeita Torii Director Funai Tokyo Technology Center Building. 1-14-1 Kandasuda-cho Chiyoda-ku, Tokyo 101-0041 JAPAN

Re: K161881

Trade/Device Name: PreXion3D Excelsior Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: September 8, 2016 Received: September 9, 2016

Dear Mr. Torii:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ocks

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161881

Device Name PreXion3D Excelsior

Indications for Use (Describe)

PreXion3D Excelsior is intended to produce two dimensional digital panoranic and cephalometric images, and three dimensional digital x-ray images of the 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 wrist to obtain carpus innages for growth and maturity assessment.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

510(k) Number: K161881

5.1 Applicant Information

Date Prepared:	Sep. 8th, 2016
Company Name and Address:	PreXion Corporation
Funai Tokyo technology center building,
1-14-1 Kandasuda-cho, Chiyoda-ku
Tokyo, 101-0041
Japan
Contact Person:	Mr. Shumpeita Torii
Director, Quality Assurance and Regulatory Division
Phone: +81-3-5297-7551
FAX: +81-3-5297-7552
Email: torii@prexion.co.jp

5.2 Device Information

Device Type:	Dental Cone-beam Computed Tomography
Regulation Description:	Computed Tomography X-Ray System
Review Panel:	Radiology
Regulation Number:	21 CFR 892.1750
Product Code:	OAS
Device Class:	II
Device Name:	Prexion3D Excelsior

5.3 Predicate Devices

The legally marketed devices to which substantial equivalence is being claimed are:

510(k) Number:	K122199	K103659	K133620
Applicant:	THE YOSHIDA
DENTAL MFG. CO.,
LTD.	Trophy	Imaging Sciences
International, LLC
Device Name:	PREXION 3D
ECLIPSE	CS 9300 and CS
9300C	i-CAT FLX Cone Beam
3D and 2D Panoramic
Dental Imaging System
Regulation Number:	21 CFR 892.1750	21 CFR 892.1750	21 CFR 892.1750
Product Code:	OAS	OAS	OAS
Device Class:	II	II	II

4

5.4 Device Description

PreXion3D Excelsior 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 Excelsior 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.

During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.

5.5 Intended Use/Indications for Use

PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital x-ray images of the 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.

5.6 Technological Characteristics

The subject device compares to the legally marketed devices as follows:

	Subject Device	Predicate device
	PreXion3D
Excelsior	PREXION 3D
ECLIPSE
(K122199)	CS 9300 and CS
9300C
(K103659)	i-CAT FLX Cone
Beam 3D and 2D
Panoramic
Dental Imaging
System
(K133620)
Device
Intended
Use/Indications
for Use	PreXion3D
Excelsior is
intended to
produce two
dimensional digital
panoramic and
cephalometric
images, and three
dimensional digital
x-ray images of
the maxillofacial,
and ENT (Ear,
Nose and Throat)
region at the	PREXION3D
ECLIPSE is
intended to
produce two-
dimensional digital
panoramic and
cephalometric
images, and three-
dimensional digital
x-ray images of
the dento-maxillo-
facial region at the
direction of
healthcare	The CS 9300 and
CS 9300C are
systems intended
to produce two-
dimensional and
three-dimensional
digital x-ray
images of the
dento-maxillo-
facial, and ENT
(Ear, Nose and
Throat) regions at
the direction of
healthcare	Devices of the i-
CAT family consist
of an x-ray system
that uses a cone
beam with a
rotational
sequence,
providing two
dimensional
images and three
dimensional
volume
reconstructions of
the head area,

5

| Device | Subject Device | PreXion3D
Excelsior | PREXION 3D
ECLIPSE
(K122199) | Predicate device | CS 9300 and CS
9300C
(K103659) | i-CAT FLX Cone
Beam 3D and 2D
Panoramic
Dental Imaging
System
(K133620) |
|-------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| | | 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. | professionals as
diagnostic
support. | professionals as
diagnostic support
for pediatric and
adult patients.
In addition, the CS
9300C is intended
to produce
cephalometric
images. This
includes imaging
the hand and wrist
to obtain the
carpus image for
growth and
maturity
assessment. | which includes
ENT and
maxillofacial areas
(such as TM Joint
studies, mandible
& maxilla for
implant planning,
sinuses), for use
in planning and
diagnostic support
in adult and
pediatric care.
Devices of the i-
CAT family
comprise a
package of
software modules
capable of
handling 2D and
3D data. This
includes 3D
reconstruction,
storage, retrieval,
viewing, and
processing of 2D
and 3D-image
data. | |
| X-ray
Gene
ration
Device | Tube
Voltage | 60-110KV | 50-90 kV | 60 - 90 kV | 84-120 kV
94 kV (Panoramic)
84 kV (Panoramic
small) | |
| | Pulse
Exposu
re
function | Yes | N/A | Yes | Yes | |
| | Tube
Current | 1-6mA | 2.6-4 mA | 2 - 15 mA | 3-7mA
5mA (Panoramic
and Panoramic
small) | |
| | Focal
Spot
Size | 0.3mm | 0.2 mm | 0.7 mm | 0.5mm | |
| X-ray
Imag
e | Detector | FPD (TFT) | FPD (CMOS) | FPD (TFT) | FPD (TFT) | |
| | Pixel
Size | 125 μm | 200 μm (CT) | 127 μm | 127um x 127um | |
| Device | Subject Device | PreXion3D Excelsior | PREXION 3D ECLIPSE (K122199) | Predicate device CS 9300 and CS 9300C (K103659) | i-CAT FLX Cone Beam 3D and 2D Panoramic Dental Imaging System (K133620) | |
| uring Devic e | | x250μm(CT)
125 μm x 125μm(Panoramic )
140 μm x 140μm (Ceph) | 100 μm (Panoramic)
54 μm (Ceph) | | | |
| | Pixel Number | 1280x1024 (CT)
100x1280 (Panoramic)
2112x1754 (Cephalometric) | 640x656 (CT)
80x1312 (Panoramic)
128x4080 (Ceph) | 64 x 1536 (Panoramic) | 1536 x 1920
768 x 960 | |
| | Size of Area Receiving X-ray | 160mm x 128mm (CT)
160mm x 12.5mm (Panoramic)
295.68 x 245.56mm (Ceph) | 128.1 mm x 131.3 mm (CT)
8 mm x 131.3 mm (Panoramic)
6.9 mm x 312 mm (Ceph) | 5 x 149 mm max (Panoramic) | 242mm x 192mm (CT)
10mm x 100mm (Panoramic) | |
| | Number of Bits | 16bits (CT, Panorama)
14bits (Ceph) | 14 bits (CT, Panoramic)
16 bits (Ceph) | 14 Bits | 16 bits | |
| | SID/SOD | 700mm/ 470mm (CT, Panoramic)
1650mm / 1500mm (Ceph) | 620 mm / 400 mm (CT, Panoramic)
1650 mm / 1500 mm (Ceph) | 615 mm (SID) | 714mm / 495mm | |
| Scan ner | Dimension (WxDxH) | 930 mm x 1230 mm x 2220 mm (CT, Panoramic)
1747 mm x 1230 mm x 2220 mm (with Ceph) | 1245 mm x 1288 mm x 2045 mm (CT, Panoramic)
1805 mm x 1288 mm x 2045 mm (Ceph) | 1158 mm x 1595 mm x 2378 mm | 1222mm x 1340mm x 1820mm | |
| | Device | Subject Device
PreXion3D
Excelsior | PREXION 3D
ECLIPSE
(K122199) | Predicate device
CS 9300 and CS
9300C
(K103659) | i-CAT FLX Cone
Beam 3D and 2D
Panoramic
Dental Imaging
System
(K133620) | |
| | Weight | 165 kg (CT,
Panoramic)
200kg (Ceph) | 260 kg (CT,
Panoramic)
300 kg (Ceph) | 160 kg (CT,
Panoramic)
190 kg (Ceph) | 231kg | |
| Imaging Mode | | CT scan,
Panoramic scan,
Cephalometric
radiography | CT scan,
Panoramic scan,
Cephalometric
radiography | CT scan,
Panoramic scan,
Cephalometric
radiography | CT scan,
Panoramic scan | |
| Panoramic
Scan
Performance
(Scan Time) | | 4-16sec | Standard mode:
16 sec | 4 - 16 sec | 18.3 -20.0 sec | |
| Cephalometric
Radiography
(Scan Time) | | 0.5-0.8 sec | LA, PA, Carpus:
8, 10, 12, 15 sec | 0.1 - 3.2 sec | N/A | |
| CT
Scan
Perfo
rman
ce | Scan
Time | 6.9-25.6sec | Light mode: 8.7
sec
High Definition
mode: 8.7 sec
Ultra High
Definition mode:
17.4 sec
Wide mode: 9.1
sec x 2 | 12 - 20 sec
28 sec | 4.8 - 26.9 sec | |
| | FOV
(Voxel
Size) | Diameter 100mm
x H76mm
(0.100 - 0.200mm)
Diameter 150mm
x H75 (0.200mm)
Diameter 100mm
x H50mm
(0.100 - 0.200mm)
Diameter 50mm x
H50mm
(0.100 - 0.200mm) | Light mode, High
Definition mode,
Ultra High
Definition mode:
Diameter 81 mm,
H 75 mm
Wide Mode:
Diameter 113 mm,
H 72 mm | Diameter 170 mm/
H135 mm (0.090
mm - 0.500 mm)
Diameter 170 mm/
H110 mm (0.090
mm - 0.500 mm)
Diameter 170 mm/
H60 mm (0.090
mm - 0.500 mm)
Diameter 100 mm/
H100 mm (0.090
mm - 0.500 mm) | Diameter x Height
8 cm x 8 cm
16 cm x 4 cm
16 cm x 6 cm
16 cm x 8 cm
16 cm x 10 cm
16 cm x 11 cm
16 cm x 13 cm
23 cm x 17 cm
(3D ceph)
Voxel size: 0.125,
0.2, 0.25, 0.3,
0.4mm | |

6

7

8

	Subject Device	Predicate device
Device	PreXion3D
Excelsior	PREXION 3D
ECLIPSE
(K122199)	CS 9300 and CS
9300C
(K103659)	i-CAT FLX Cone
Beam 3D and 2D
Panoramic
Dental Imaging
System
(K133620)
Volume Size	512x512x512
1024x1024x800	512x512x512	250 x 250 x 250
267 x 267 x 267
339 x 339 x 220
567 x 567 x 367-
450
850 x 850 x 300	320x320x288
536x536x443
768x768x288
Dose Level
(CTDIw)	Standard (110KV,
3.3mA, 12.8s)
10cm: 2.9mGy
5cm: 1.9mGy

Rapid (110KV,
2.1mA, 6.9s)
10cm: 0.9mGy
5cm: 0.8mGy

High Resolution
(110KV, 3.6mA,
25.6s)
10cm: 4.9mGy
5cm: 3.2mGy

High Contrast
(110KV, 2.1mA,
25.6s)
10cm: 8.7mGy
5cm: 5.7mGy

Standard Child
(95KV, 2.2mA,
12.8s)
10cm: 1.4mGy
5cm: 1.0mGy

Rapid Child | High Definition
(90KV, 4mA, 8.7s)
8cm: 4.57mGy

Ultra High
Definition (90KV,
4mA, 17.4s)
8cm: 9.32mGy

Wide (90KV, 4mA,
9.1s x 2)
11cm: 6.67mGy

Light (90KV,
2.6mA, 8.7s)
8cm: 3.01mGy | 90KV, 6.3mA,
12sec, 8cm x 8cm:
4.31mGy

90KV, 6.3mA,
12sec, 5cm x 5cm:
3.70mGy

90KV, 6.3mA,
20sec, 5cm x 5cm:
6.46mGy | 3D Ceph (120KV,
5mA, 8.9s)
13cm: 1.9mGy*,
11cm: 1.9mGy*,
10cm: 1.9mGy*,
8cm: 2.0mGy*,
6cm: 2.0mGy*,
4cm: 2.1mGy*

Quick Scan
(120KV, 5mA,
4.8s)
13cm: 1.0mGy*,
11cm: 1.0mGy*,
10cm: 1.0mGy*,
8cm: 1.0mGy*,
6cm: 1.0mGy*,
4cm 1.6mGy*:

Quick Scan+
(90KV, 3mA, 4.8s)
13cm: 0.3mGy*,
11cm: 0.3mGy*,
10cm: 0.3mGy*,
8cm: 0.3mGy*,
6cm: 0.3mGy*,
4cm: 0.3mGy*

HD (120KV, 5mA, | |
| | Subject Device | | Predicate device | | |
| Device | PreXion3D
Excelsior | PREXION 3D
ECLIPSE
(K122199) | CS 9300 and CS
9300C
(K103659) | i-CAT FLX Cone
Beam 3D and 2D
Panoramic
Dental Imaging
System
(K133620) | |
| | (95KV, 1.6mA,
6.9s)
10cm: 0.5mGy
5cm: 0.4mGy | | | 26.9s)
13cm: 3.8mGy*,
11cm: 3.9mGy*,
10cm: 3.6mGy*,
8cm: 4.0mGy*,
6cm: 4.0mGy*,
4cm: 4.2mGy*
Quick Scan HD
(120KV, 5mA,
14.7s)
13cm: 2.1mGy*,
11cm: 2.1mGy*,
10cm: 2.0mGy*,
8cm: 2.1mGy*,
6cm: 2.1mGy*,
4cm: 2.2mGy*

the sum of
1/3 of the phantom
central dose and
2/3 of the
peripheral dose. | |
| Performance
Standards | ANSI/AAMI
ES60601-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 62366
IEC 62304
IEC 60601-2-63
IEC 61223-3-4
IEC 61223-3-5
IEC 60825-1
ISO 14971
NEMA PS 3.1 -
3.20
ISO 10993-1
ISO 10993-5
ISO 10993-10 | UL 60601-1
IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-2-7
IEC 60601-2-28
IEC 60601-2-32
IEC 60825-1
IEC 61233-3-4
IEC 61223-3-5
IEC 62304
ISO 14971
NEMA PS 3.1 -
3.20 | Unknown | IEC 60601-1:
2005
IEC 60601-1-
6:2010
IEC 62366:2007
IEC 60601-2-
63:2012
IEC 60601-1-2:
2007
ISO 10993-5
ISO 10993-10 | |

9

10

5.7 Non-Clinical Performance Data

The subject device has demonstrated conformance to non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:

ANSI/AAMI ES60601-1 IEC 60601-1-2 IEC 60601-1-3 IEC 60601-1-6 IEC 62366 IEC 62304 IEC 60601-2-63 IEC 61223-3-4 IEC 61223-3-5 IEC 60825-1 ISO 14971 NEMA PS 3.1 - 3.20 ISO 10993-1 ISO 10993-5 ISO 10993-10

In addition to the conformance with the above recognized standards, the following testing and nonclinical considerations were preformed:

. Testing for 3D imaging performance to assess MTF for three image orientations (x, y, z) for the applicable 3D modes of device operation.
. Non-clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"

Results of all non-clinical testing and non-clinical considerations support the safety and effectiveness of the subject device.

5.8 Clinical Performance Data

Clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" were performed by the qualified clinical assessors. Results of the clinical consideration support the safety and effectiveness of the subject device.

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5.9 Conclusions

The subject device has the same intended use/Indications for use as the predicate devices. The subject and predicate devices also share similar technological characteristics such as specifications of X-ray Generation Device. X-ray Image Capturing Device and Scanner. Imaging Mode (i-CAT does not have a Cephalometric imaging mode), Scan Mode and conformance with Performance Standards. The subject and predicate devices also have differences in technological characteristics, such as Tube Voltage, Pulse Exposure, Tube Current, Focal Spot Size, Pixel Number, Size of Area Receiving X-ray, Detector, Number of Bits, Scanner SID/SOD, Panoramic Scan Performance (Scan Time), Cephalometric Radiography (Scan Time), CT Scan Time, FOV (Voxel Size), Volume Size, Dose Level (CTDIw) and Performance Standards.

We conducted non-clinical and clinical performance testing as follows:

Conformance with the harmonized standards .
Testing for 3D imaging performance to assess MTF for the three image orientations .
. Non-clinical and Clinical considerations according to FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"

Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and non-clinical performance data and clinical performance data demonstrates that the subject device is substantially equivalent to the legally marketed devices identified in this submission.