COMPUTED TOMOGRAPHY X-RAY SYSTEM

K102196 · VATECH Co., Ltd. · OAS · Mar 25, 2011 · Radiology

Device Facts

• Record ID: K102196
• Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Applicant: VATECH Co., Ltd.
• Product Code: OAS · Radiology
• Decision Date: Mar 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

PaX-Zenith3D is a computed tomography x-ray system intended to take panoramic, cross-sectional images of the oral and craniofacial anatomy and provide diagnostic information for children and adults clinical care in dentistry. The device is operated and used by x-ray technicians and dentists including oral surgeons.

Device Story

PaX-Zenith3D is a dual-modality dental X-ray system combining cone beam CT and panoramic imaging. It utilizes embedded digital sensors to capture 2D and 3D radiographic data of oral and craniofacial anatomy. Operated by dentists or X-ray technicians in clinical settings, the system processes raw sensor data via integrated software to generate high-definition diagnostic images in real-time. These images assist clinicians in dental diagnosis and treatment planning. The device benefits patients by providing detailed anatomical visualization for clinical care.

Clinical Evidence

Bench testing performed per IEC 60601 series and FDA guidance for solid-state X-ray imaging devices. Performance metrics included MTF, DQE, and SNR comparisons against the predicate. Clinical evidence consisted of sample images demonstrating diagnostic quality comparable to the predicate device.

Technological Characteristics

Dual-modality cone beam CT and panoramic X-ray system. Features embedded digital sensors. Complies with IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, 60601-2-44, and 60601-1-2 (EMC). Supports DICOM (NEMA PS 3.1-3.18) connectivity.

Indications for Use

Indicated for children and adults requiring panoramic and cross-sectional imaging of oral and craniofacial anatomy for dental diagnostic purposes.

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

• Picasso-Duo (K090991)

Reference Devices

• Xmaru 1501CF

Submission Summary (Full Text)

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K102196

MAR 2 5 2011

# 510(k) Summary (Revised)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800.

#### Date

November 22, 2010

#### Manufacturer

VATECH Co., Ltd. 23-4, Seogu-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Korea

Tel: [phone] Fax: [phone] Contact person: Mr. Hyuk-jun Choi

#### United States Sales Representative (U.S. Designated agent)

VATECH America Inc. 333 Meadowlands Parkway #303, Secaucus, NJ 07094, USA Tel: [phone] Fax: [phone] Contact person: Mr. Dave Kim

Trade/Proprietary Name: PaX-Zenith3D

Computed Tomography X-ray System Common Name:

#### Classification Name:

System, X-ray, Tomography, Computed (21CFR 892.1750, Product code OAS, Class2)

#### Description:

PaX-Zenith3D is a dual X-ray machine which combines cone beam CT and panoramic X-ray modality to offer high definition digital diagnostic images in multi FOV for dental practitioners. Separately embedded panorama and CT sensors capture 2D and 3D images based on digital and CT technology while the most advanced digital imaging process enables the capture S/W program to provide one of the most effective image analysis and diagnosis in real time.

#### Indication for use:

PaX-Zenith3D is a computed tomography x-ray system intended to take panoramic, cross-sectional images of the oral and craniofacial anatomy and provide diagnostic information for children and adults clinical care in dentistry. The device is operated and used by x-ray technicians and dentists including oral surgeons.

Vatech Co.,Ltd.

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#### Predicate Device:

| Manufacturer | : E-WOO Technology Co., Ltd. |
|--------------|-----------------------------------------------------|
| Device | : Picasso-Duo |
| | 510(k) Number : K090991 (Decision Date - 10/9/2009) |

#### Substantial Equivalence:

PaX-Zenith3D described in this 510(k) has the similar intended use and technical characteristics as the Picasso-Duo of E-WOO Technology Co., Ltd.

The indications for use, material, form factor, performance, and safety characteristics between PaX-Zenith3D and the predicate device are similar. The primary differences are size, cosmetic, structure and component used only. Accordingly we can claim the substantially equivalence of PaX-Zenith3D to the predicate device.

The actual spatial resolution data for a digital panorama image for Xmarul 501CF for PaX-Zenith3D and S7199-01 for Picasso-Duo are almost identical after considering pixel binning of S7199-01. 5.0 lp/mm(Xmaru1501CF) and 5.2 lp/mm(S7199-01), respectively, Further technical details of the pixel binning for S7199-01 is described in the Executive Summary (Tab 10).

The similar technical characteristics of both devices are further described in the SSXI Non Clinical Report (Tap 25, 26, and 27) in terms of MTF, DQE, and SNR comparison. Finally, the sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well.

### Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A)+A2, 1995), IEC 606061-1-1(2001), IEC 60601-1-3(Ed.1, 2006), IEC 60601-2-7 (1998), IEC 60601-2-28 (Ed.1, 1993), IEC 60601-2-32 (Ed.3, 2007) and IEC 60601-2-44 (Ed.2+A1, 2002) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.

Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed.

All test results were satisfactory.

PaX-Zenith3D also meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.

#### Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. VATECH Co., Ltd. concludes that PaX-Zenith3D is safe and effective and substantially equivalent to predicate device as described herein.

END

Vatech Co.,Ltd.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Consultant VATECH America 333 Meadowlands Parkway, #303 SECAUCUS NJ 07094

MAR 2 5 2511

Re: K102196

Trade/Device Name: PaX-Zenith3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: March 8, 2010 Received: March 16, 2010

Dear Mr. Kim:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(K) Number (if known):

Device Name: PaX-Zenith3D

Classification: Computed Tomography X-ray System

#### Indications for Use:

PaX-Zenith3D is a computed tomography x-ray system intended to take panoramic, cross-sectional images of the oral and craniofacial anatomy and provide diagnostic information for children and adults clinical care in dentistry. The device is operated and used by x-ray technicians and dentists including oral surgeons.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF needed)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Mary Patil

510K.

Division of Radiological Device Division of Haulologicul Device Evaluation and Safety

He

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