← Product Code [OAS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS) · K171012

# Veraview X800 (K171012)

_J. Morita USA, Inc. · OAS · Dec 19, 2017 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS/K171012

## Device Facts

- **Applicant:** J. Morita USA, Inc.
- **Product Code:** [OAS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS.md)
- **Decision Date:** Dec 19, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1750
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric

## Intended Use

The Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients.

## Device Story

Veraview X800 is an extraoral X-ray system for dental/head imaging; provides panoramic, cephalometric, and cone beam computed tomography (CBCT) modalities. Device uses cone-shaped X-ray beam projected onto CMOS flat panel/CCD detectors; captures raw projection data; software reconstructs 2D/3D images for viewing on external workstations. Operated by dentists/qualified professionals in clinical settings. Output assists in diagnosis of teeth, jaw, TMJ, and skull structures; aids in hand maturity assessment. Benefits include high-resolution diagnostic imaging for treatment planning. System includes X-ray arm, high-voltage generator, patient positioning device, and control assembly.

## Clinical Evidence

No clinical tests performed. Substantial equivalence is supported by non-clinical bench testing, including imaging performance metrics (spatial resolution, noise, MTF) for panoramic, cephalometric, and CBCT modes, and compliance with international safety standards (IEC 60601 series, ISO 10993, ISO 14971).

## Technological Characteristics

Extraoral X-ray system; CMOS flat panel and CCD detectors; CsI scintillator. Tube potential 60-100kV; tube current 2-10mA. Imaging modes: panoramic, cephalometric, CBCT. Connectivity: 2D/3D viewing stations. Software-based image reconstruction. Conforms to IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 60601-2-63, 61223-3-4, 62304, 62366, ISO 10993-1, ISO 14971.

## Regulatory 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

- OP300 ([K133544](/device/K133544.md))

## Reference Devices

- ORTHOPANTOMOGRAPH™ OP 3D ([K170813](/device/K170813.md))
- Veraviewepocs X550 ([K073696](/device/K073696.md))
- i-Dixel ([K073704](/device/K073704.md))

## Submission Summary (Full Text)

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December 19, 2017

Image /page/0/Picture/1 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.

J.Morita USA, Inc. % Keith Barritt Attorney Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005

## Re: K171012

Trade/Device Name: Veraview X800 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: March 30, 2017 Received: April 4, 2017

Dear Keith Barritt:

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 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);

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## Page 2 - Keith Barritt

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Robert Ochs

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

510(k) Number (if known) K#171012

Device Name Veraview X800 X-Ray System

#### Indications for Use (Describe)

The Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.

The Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation.

The device uses a cone shaped X-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.

The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult 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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## 510(k) Summary J. Morita USA Inc. Veraview X800 X-ray system for Panoramic, Cephalometric and CBCT imaging

The following information is provided pursuant to 21 CFR 807.92.

## 807.92(a)(1): Submitter's Name/Address, Contact, and Preparation Date

### (i) 510(k) Submitter

Registration No. 2081055 J. Morita USA, Inc. 9 Mason, Irvine, CA 92618, USA Phone: 949-581-9600 Fax: 949-581-9688

## (ii) 510(k) Submitter Contact

Keith A. Barritt Fish & Richardson P.C. 901 15th Street, Suite 700 Washington DC 20005, USA Phone: (202) 783-5070 Fax: (202) 783-2331 Email: barritt@fr.com

### (iii) Preparation Date

December 14, 2017

### 807.92(a)(2): Name of Device

| Trade or Proprietary Name:   | Veraview X800                                   |
|------------------------------|-------------------------------------------------|
| Model Name:                  | X800                                            |
| Common Name:                 | Dental Computed Tomography X-ray System imaging |
| Classification Name:         | Computed tomography x-ray system                |
| Device Classification Panel: | Class II, Radiology                             |
| Product Code:                | OAS                                             |
| Regulation:                  | 21 CFR 892.1750                                 |

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#### 807.92(a)(3): Predicate Device

The Veraview X800 is substantially equivalent for purposes of FDA medical device regulations to the following primary predicate device:

| Trade or Proprietary Name:   | OP300 (K#133544)                                                                 |
|------------------------------|----------------------------------------------------------------------------------|
| Common Name:                 | Dental panoramic cephalometric and cone beam computed<br>tomography x-ray device |
| Classification Name:         | Computed tomography x-ray system                                                 |
| Device Classification Panel: | Class II, Radiology                                                              |
| Product Code:                | OAS                                                                              |
| Regulation:                  | 21 CFR 892.1750                                                                  |

K#170813 is a secondary/reference predicate device:

| Trade or Proprietary Name:   | ORTHOPANTOMOGRAPH™ OP 3D (K#170813) |
|------------------------------|-------------------------------------|
| Common Name:                 | X-ray, Tomography, Computed, Dental |
| Classification Name:         | Computed tomography x-ray system    |
| Device Classification Panel: | Class II, Radiology                 |
| Product Code:                | OAS                                 |
| Regulation:                  | 21 CFR 892.1750                     |

- J. MORITA CORP.'s own X550 (K#073696) is a secondary/reference predicate device:

| Common Name:                 | Dental Panoramic/Cephalometric X-ray System with CT<br>Capability |  |
|------------------------------|-------------------------------------------------------------------|--|
| Classification Name:         | Extra-oral source dental x-ray system                             |  |
| Device Classification Panel: | Class II, Radiology                                               |  |
| Product Code:                | MUH                                                               |  |
| Regulation:                  | 21 CFR 872.1800                                                   |  |

#### 807.92(a)(4): Device Description

The Veraview X800 consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction.

The Veraview X800 has three main radiographic modes as follows:

- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- -Cone beam computed tomography

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## 807.92(a)(5): Intended Use

The intended use of the X800 is:

- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- Cone beam computed tomography -

The intended use of the primary predicate device is:

The OP300 dental panoramic, cephalometric and cone beam computed tomography x-rav device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

## Indication for Use

Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation.

The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.

The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients.

### 807.92(a)(6): Technological Characteristics

Comparison tables of the Veraview X800 and (1) the primary predicate K#133544 and reference device K#170813 and (2) the reference device K#073696 appear below:

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|                                           | Proposed device                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Primary predicate device (ORTHOPANTOMOGRAPH™ OP300, K133544)                                                                                                                                                                                                                                                                                                                        | Reference predicate device (ORTHOPANTOMOGRAPH™ OP 3D, K170813)                                                                                                                                                                                     |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1<br>Indications for Use/<br>Intended Use | Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients | The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals. | ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device to take panoramic and 3D images of the craniomaxillofacial complex for use in diagnostic support. ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals |

Comparison table for the primary predicate K133544 and reference K#170813 devices:

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|    |                                                      | Proposed device                                                | Primary predicate<br>device<br>(ORTHOPANTOMO<br>GRAPH™ OP300,<br>K133544) | Reference predicate device<br>(ORTHOPANTOMOGRAPH™<br>OP 3D, K170813)  |
|----|------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------|
| 2  | Imaging<br>modes                                     | Panoramic<br>CBCT<br>Cephalometric                             | Panoramic<br>CBCT<br>Cephalometric                                        | Panoramic<br>CBCT                                                     |
| 3  | Focal spot                                           | 0.5                                                            | 0.5                                                                       | 0.5                                                                   |
| 4  | Image<br>detector                                    | CMOS Flat Panel +CCD<br>detector<br>(ceph)                     | CMOS Flat Panel<br>+CMOS detector<br>(Pan/ceph)                           | CMOS Flat Panel                                                       |
| 5  | CBCT<br>imaging<br>technique                         | Reconstruction from 2D<br>images                               | Reconstruction from<br>2D images                                          | Reconstruction from 2D images                                         |
| 6  | CBCT's<br>Field Of<br>View<br>(cm)                   | 4 x 4<br>8 x 4, 5, 8<br>10 x 4, 5, 8<br>15 x 5, 7.5, 14        | 5x5<br>6x8<br>8x8<br>8x15<br>13x15                                        | 5 x 5<br>6 x 9<br>9 x 11<br>9 x 14                                    |
| 7  | CBCT's<br>total<br>viewing<br>angle                  | 180, 360 degree                                                | 360 degree                                                                | 360 degree                                                            |
| 8  | CBCT's<br>effective<br>exposure<br>time (s)          | Scout: 0.5, 1.0<br>CBCT: 9.4, 17.9<br>17.9 x 2 for FOV 15 x 14 | 1.2 - 12.5                                                                | 1.7 - 20                                                              |
| 9  | CBCT<br>Reconstru<br>ction<br>Time                   | 1-6 min. (depending on<br>the computer<br>specification)       | 1-3 min.                                                                  | 1-3 min.                                                              |
| 10 | Patient's<br>Position                                | Standing and wheelchair                                        | Standing and<br>wheelchair                                                | Standing and wheelchair                                               |
| 11 | System<br>footprint<br>(includes<br>the<br>operator) | H218.5-232.5cm D120cm<br>W140-200 cm                           | H161-241cm<br>D139cm<br>W97-193 cm                                        | H167-247cm<br>D77-100cm<br>130 cm                                     |
| 12 | Weight                                               | Pan/CBCT 185-190 kg<br>Ceph 220-225 kg                         | Pan/CBCT 205 kg<br>Ceph 240 kg                                            | 100 kg                                                                |
| 13 | Classificat<br>ion                                   | OAS                                                            | OAS                                                                       | OAS                                                                   |
| 14 | CBCT<br>resolution                                   | Standard, high resolution                                      | Low , standard, high,<br>endo                                             | Low , standard, high, endo                                            |
|    |                                                      | Proposed device                                                | Primary predicate device<br>(ORTHOPANTOMO<br>GRAPHTM OP300,<br>K133544)   | Reference predicate device<br>(ORTHOPANTOMOGRAPHTM<br>OP 3D, K170813) |
|    |                                                      |                                                                |                                                                           |                                                                       |
| 15 | 2D<br>imaging<br>programs                            | Adult Pan, Child Pan,<br>TMJ, BW, Partial Pan                  | Adult Pan, Child Pan,<br>TMJ, BW,<br>Partial Pan                          | Adult Pan, Child Pan, TMJ, BW,<br>Partial Pan                         |
| 16 | -                                                    | -                                                              | -                                                                         | -                                                                     |
| 17 | CMOS flat<br>panel pixel<br>size                     | 0.1 mm x 0.1 mm                                                | 100 μm x 100 μm                                                           | 99 μm x 99 μm                                                         |
| 18 | System<br>MTF                                        | 2.5 lp/mm @10%<br>FOV 4x4<br>High Resolution                   | 2.25 lp/mm @10%<br>FOV 5x5<br>High Resolution                             | 2.2 lp/mm@10%<br>FOV 5x5<br>High Resolution                           |

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Comparison table for the reference predicate K#073696 is as follows:

| Item                            | Device submitted in this 510(k)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Reference device                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |        | Loading factors        | Tube Potential: 60-100kV<br>Tube Current: 2-10mA<br>Loading time: max. 18.5s                                                                            | Tube Potential: 60-90kV<br>Tube Current: 1-10mA<br>Loading time: max. 20.3s                                                                             |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name                    | Veraview X800                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | Veraviewepocs                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Design | X-ray tube<br>assembly | Nominal focal spot: 0.5 at target<br>angle<br>Inherent filtration min. 2.5mmAL                                                                          | Nominal focal spot: 0.5 at target<br>angle<br>Inherent filtration min.<br>2.5mmAL                                                                       |
| Model                           | X800                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | X550                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |        | X-ray detector 1       | Internal parts code: D001-15038-<br>50*<br>See column in predicate device.                                                                              | Internal parts code: D001-<br>15038-50*<br>CMOS flat panel<br>Scintillator: CsI<br>Pixel size for Pan: 0.1 mm<br>Pixel size for CBCT: 0.1 mm,<br>0.2 mm |
| Manufacturer                    | J. MORITA MFG. CORP.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | J. MORITA MFG. CORP.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |        | X-ray detector 2       | Internal parts code: D001-16044-<br>50*<br>CMOS flat panel<br>Scintillator: CsI<br>Pixel size for Pan: 0.1 mm<br>Pixel size for CBCT: 0.1 mm,<br>0.2 mm | Internal parts code: D00-<br>113030-50*<br>CMOS flat panel<br>Scintillator: CsI<br>Pixel size for Pan and CBCT:<br>0.2 mm                               |
| Indications for use             | Veraview X800 is intended to be<br>used for panoramic tomography<br>including linear tomography and<br>scanogram, cephalometric<br>radiography, and cone beam<br>computed tomography.<br>Veraview X800 is an extraoral<br>source X-ray unit that is used for<br>dental and head radiographic<br>examination and diagnosis of<br>teeth, jaw, oral structure,<br>temporomandibular joint, skull<br>including the dento-maxillofacial<br>areas, and hand for maturity<br>assessment, by exposing an X-ray<br>image receptor to ionizing<br>radiation.<br>The device uses a cone shaped X-<br>ray beam projected on to a flat<br>panel detector, and the examined<br>volume image is reconstructed to<br>be viewed in 2D or 3D viewing<br>stations.<br>The device is to be operated and<br>used by dentists and other legally<br>qualified professionals for<br>pediatric and adult patients. | The Veraviewepocs is an<br>extraoral source X-ray unit that<br>is used for dental radiographic<br>examination and diagnosis of<br>teeth, jaw, oral structure, TM-<br>joints and skull including the<br>ENT and dento-maxillofacial<br>areas, by exposing an X-ray<br>image receptor to ionizing<br>radiation.<br>The device uses cone shaped X-<br>ray beam projected on to a flat<br>panel detector, and the examined<br>volume image is reconstructed to<br>be viewed in 2D or 3D viewing<br>stations.<br>The device is to be operated and<br>used by dentists and other<br>legally qualified professionals. |        | X-ray detector 3       | Internal parts code: D001-04188-<br>50*<br>See column in predicate device.                                                                              | Internal parts code: D001-<br>04188-50*<br>CCD line sensor<br>Scintillator: CsI<br>Pixel size for Ceph: 0.1 mm                                          |
| Energy used and/or<br>delivered | AC 120 V, 60 Hz                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | AC 120 V, 60 Hz                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |        | Soft-<br>ware          | Viewer<br>(general purpose<br>viewer: not<br>included in this<br>submission of<br>the device)                                                           | Viewer software:<br>510K number: K073704<br>Device name: i-Dixel                                                                                        |

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|                          | Panoramic<br>- spatial<br>resolution | Line pair resolution on IEC<br>61223-3-4: min. 2.5 LP/mm                                                                                        | Line pair resolution: min. 2.5<br>LP/mm                                                                                                            |
|--------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Perfor                   | Panoramic<br>- noise                 | Low contrast resolution on IEC<br>61223-3-4: min. diameter 2.0 mm<br>at High speed mode, min.<br>diameter 1.0 mm at High<br>resolution mode     | Low contrast resolution on IEC<br>61223-3-4: min. diameter 2.0<br>mm                                                                               |
|                          | mance                                | Cephalometric<br>- spatial<br>resolution                                                                                                        | Line pair resolution on IEC<br>61223-3-4: min. 2.5 LP/mm                                                                                           |
| Cephalometric<br>- noise |                                      | Low contrast resolution on IEC<br>61223-3-4: min. diameter 2.5 mm                                                                               | Low contrast resolution on IEC<br>61223-3-4: min. diameter 2.5<br>mm                                                                               |
|                          | CBCT<br>- spatial<br>resolution      | min. 10% MTF at 2.0 LP/mm at<br>standard mode<br>min. 10% MTF at 2.5 LP/mm at<br>high resolution mode                                           | min. 10% MTF at 2.0 LP/mm                                                                                                                          |
|                          | CBCT<br>- noise                      | The standard deviation of the gray<br>scale of the center region of the<br>Contrast phantom shall be less<br>than 12.5 (10% of the full scale). | The standard deviation of the gray<br>scale of the center region of the<br>Contrast phantom shall be<br>less than 12.5 (10% of the full<br>scale). |

# 807.92(b)(l): Non-clinical Testing

The Veraview X800 has been tested for compliance and developed in accordance with the following international standards:

| IEC/ISO Standard              | FDA Recognition number |
|-------------------------------|------------------------|
| IEC 60601-1:2005+A.MD1:2012   | 19-4                   |
| IEC 60601-1-2:2007            | 19-1                   |
| IEC 60601-1-3:2008+AMD1: 2013 | 12-269                 |
| IEC 60601-1-6:2010+AMD1:2013  | 5-89                   |
| IEC 60601-2-54:2009+AMD1:2015 | 12-296                 |
| IEC 60601-2-63:2012           | 12-251                 |
| IEC 61223-3-4:2000            | 12-224                 |
| IEC 62304:2006+AMD1:2015      | 13-79                  |
| IEC 62366:2007+AMD1:2014      | 5-87                   |
| ISO 10993-1:2009/Cor1:2010    | 2-220                  |
| ISO 14971:2007                | 5-40                   |

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In addition to conformance with the above standards, non-clinical testing was conducted on the new device including imaging performance for all three modes of operation (panoramic, cephalometric, and CBCT).

## 807.92(b)(2): Clinical Testing

There were no clinical tests performed for Veraview X800.

## 807.92(b)(3): Conclusions from Testing

Based on the comparison of the Veraview X800 to the primary and reference predicates identified above and based on the non-clinical testing described above, it is concluded that the Veraview X800 is substantially equivalent to the primary predicate device.

The Veraview X800 device has the same intended use as the predicate device, and also offers the same imaging modalities as the predicate device (panoramic, cephalometric, and CBCT). Non-clinical testing demonstrates that the device performs in a substantially equivalent manner to the predicate device with regard to imaging and dose performance. Finally, the safety and overall performance of the device are demonstrated via conformance to the above stated applicable standards.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS/K171012](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS/K171012)

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