PreXion3D Excelsior

K161881 · Prexion Corporation · OAS · Oct 3, 2016 · Radiology

Device Facts

• Record ID: K161881
• Device Name: PreXion3D Excelsior
• Applicant: Prexion Corporation
• Product Code: OAS · Radiology
• Decision Date: Oct 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

PreXion3D Excelsior is a dental cone-beam computed tomography (CBCT) system. It captures X-ray data via a rotating arm with an X-ray tube and flat panel detector (FPD). The system operates in CT, panoramic, and cephalometric modes. Data is transferred to a console computer where firmware and software reconstruct diagnostic 2D/3D images. Used in clinical settings by healthcare professionals for diagnostic support in maxillofacial and ENT regions. Output includes cross-sectional diagrams and images for printing/viewing. The device aids clinicians in treatment planning and diagnosis by providing high-resolution anatomical visualization.

Clinical Evidence

No formal clinical trial data provided. Safety and effectiveness supported by non-clinical bench testing, including MTF assessment for 3D imaging performance, and clinical considerations performed by qualified assessors in accordance with FDA guidance for solid-state X-ray imaging devices.

Technological Characteristics

Dental CBCT system; X-ray generation (60-110kV, 1-6mA); 0.3mm focal spot; FPD (TFT) detector; 16-bit (CT/Panorama) and 14-bit (Ceph) depth. Connectivity via console computer. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2/1-3/1-6/2-63, IEC 62366, IEC 62304, IEC 61223-3-4/3-5, IEC 60825-1, ISO 14971, NEMA PS 3.1-3.20, ISO 10993-1/5/10.

Indications for Use

Indicated for adult and pediatric patients requiring 2D panoramic, 2D cephalometric, or 3D maxillofacial and ENT diagnostic imaging. Cephalometric imaging includes hand/wrist carpus imaging for growth/maturity assessment.

Regulatory Classification

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.

Predicate Devices

• PREXION 3D ECLIPSE (K122199)
• CS 9300 and CS 9300C (K103659)
• i-CAT FLX Cone Beam 3D and 2D Panoramic Dental Imaging System (K133620)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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)

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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<br>Funai Tokyo technology center building,<br>1-14-1 Kandasuda-cho, Chiyoda-ku<br>Tokyo, 101-0041<br>Japan |
| Contact Person: | Mr. Shumpeita Torii<br>Director, Quality Assurance and Regulatory Division<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |

# 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<br>DENTAL MFG. CO.,<br>LTD. | Trophy | Imaging Sciences<br>International, LLC |
| Device Name: | PREXION 3D<br>ECLIPSE | CS 9300 and CS<br>9300C | i-CAT FLX Cone Beam<br>3D and 2D Panoramic<br>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 |

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

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

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| | Subject Device | Predicate device | | | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device | PreXion3D<br>Excelsior | PREXION 3D<br>ECLIPSE<br>(K122199) | CS 9300 and CS<br>9300C<br>(K103659) | i-CAT FLX Cone<br>Beam 3D and 2D<br>Panoramic<br>Dental Imaging<br>System<br>(K133620) | |
| Volume Size | 512x512x512<br>1024x1024x800 | 512x512x512 | 250 x 250 x 250<br>267 x 267 x 267<br>339 x 339 x 220<br>567 x 567 x 367-<br>450<br>850 x 850 x 300 | 320x320x288<br>536x536x443<br>768x768x288 | |
| Dose Level<br>(CTDIw) | Standard (110KV,<br>3.3mA, 12.8s)<br>10cm: 2.9mGy<br>5cm: 1.9mGy<br><br>Rapid (110KV,<br>2.1mA, 6.9s)<br>10cm: 0.9mGy<br>5cm: 0.8mGy<br><br>High Resolution<br>(110KV, 3.6mA,<br>25.6s)<br>10cm: 4.9mGy<br>5cm: 3.2mGy<br><br>High Contrast<br>(110KV, 2.1mA,<br>25.6s)<br>10cm: 8.7mGy<br>5cm: 5.7mGy<br><br>Standard Child<br>(95KV, 2.2mA,<br>12.8s)<br>10cm: 1.4mGy<br>5cm: 1.0mGy<br><br>Rapid Child | High Definition<br>(90KV, 4mA, 8.7s)<br>8cm: 4.57mGy<br><br>Ultra High<br>Definition (90KV,<br>4mA, 17.4s)<br>8cm: 9.32mGy<br><br>Wide (90KV, 4mA,<br>9.1s x 2)<br>11cm: 6.67mGy<br><br>Light (90KV,<br>2.6mA, 8.7s)<br>8cm: 3.01mGy | 90KV, 6.3mA,<br>12sec, 8cm x 8cm:<br>4.31mGy<br><br>90KV, 6.3mA,<br>12sec, 5cm x 5cm:<br>3.70mGy<br><br>90KV, 6.3mA,<br>20sec, 5cm x 5cm:<br>6.46mGy | 3D Ceph (120KV,<br>5mA, 8.9s)<br>13cm: 1.9mGy*,<br>11cm: 1.9mGy*,<br>10cm: 1.9mGy*,<br>8cm: 2.0mGy*,<br>6cm: 2.0mGy*,<br>4cm: 2.1mGy*<br><br>Quick Scan<br>(120KV, 5mA,<br>4.8s)<br>13cm: 1.0mGy*,<br>11cm: 1.0mGy*,<br>10cm: 1.0mGy*,<br>8cm: 1.0mGy*,<br>6cm: 1.0mGy*,<br>4cm 1.6mGy*:<br><br>Quick Scan+<br>(90KV, 3mA, 4.8s)<br>13cm: 0.3mGy*,<br>11cm: 0.3mGy*,<br>10cm: 0.3mGy*,<br>8cm: 0.3mGy*,<br>6cm: 0.3mGy*,<br>4cm: 0.3mGy*<br><br>HD (120KV, 5mA, | |
| | Subject Device | | Predicate device | | |
| Device | PreXion3D<br>Excelsior | PREXION 3D<br>ECLIPSE<br>(K122199) | CS 9300 and CS<br>9300C<br>(K103659) | i-CAT FLX Cone<br>Beam 3D and 2D<br>Panoramic<br>Dental Imaging<br>System<br>(K133620) | |
| | (95KV, 1.6mA,<br>6.9s)<br>10cm: 0.5mGy<br>5cm: 0.4mGy | | | 26.9s)<br>13cm: 3.8mGy*,<br>11cm: 3.9mGy*,<br>10cm: 3.6mGy*,<br>8cm: 4.0mGy*,<br>6cm: 4.0mGy*,<br>4cm: 4.2mGy*<br>Quick Scan HD<br>(120KV, 5mA,<br>14.7s)<br>13cm: 2.1mGy*,<br>11cm: 2.1mGy*,<br>10cm: 2.0mGy*,<br>8cm: 2.1mGy*,<br>6cm: 2.1mGy*,<br>4cm: 2.2mGy*<br>* the sum of<br>1/3 of the phantom<br>central dose and<br>2/3 of the<br>peripheral dose. | |
| Performance<br>Standards | ANSI/AAMI<br>ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 62366<br>IEC 62304<br>IEC 60601-2-63<br>IEC 61223-3-4<br>IEC 61223-3-5<br>IEC 60825-1<br>ISO 14971<br>NEMA PS 3.1 -<br>3.20<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | UL 60601-1<br>IEC 60601-1-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-2-7<br>IEC 60601-2-28<br>IEC 60601-2-32<br>IEC 60825-1<br>IEC 61233-3-4<br>IEC 61223-3-5<br>IEC 62304<br>ISO 14971<br>NEMA PS 3.1 -<br>3.20 | Unknown | IEC 60601-1:<br>2005<br>IEC 60601-1-<br>6:2010<br>IEC 62366:2007<br>IEC 60601-2-<br>63:2012<br>IEC 60601-1-2:<br>2007<br>ISO 10993-5<br>ISO 10993-10 | |

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## 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.