DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM

K102259 · VATECH Co., Ltd. · JAK · Feb 18, 2011 · Radiology

Device Facts

• Record ID: K102259
• Device Name: DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Applicant: VATECH Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: Feb 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and x-ray technicians.

Device Story

PaX-Flex3D is a dental diagnostic imaging system utilizing a CMOS digital X-ray detector to acquire 360° rotational image sequences. It performs panoramic, cephalometric, and computed tomography (CT) imaging of the oral and maxillofacial area. Operated by physicians, dentists, or technicians in a clinical setting, the device transforms X-ray data into 3D images via computer reconstruction. These images provide diagnostic details of anatomic structures, assisting clinicians in precise treatment planning for oral surgery or other dental procedures. The system supports real-time image acquisition and reconstruction, facilitating efficient clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated against IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-2-44, and IEC 60601-1-2 standards. Non-clinical considerations followed FDA guidance for Solid State X-ray Imaging Devices. All results were satisfactory.

Technological Characteristics

System utilizes CMOS digital X-ray detector; 50-90 kV tube voltage; 4-10 mA tube current; 0.5 mm focal spot size; 2.8 mm Al total filtration. Connectivity via DICOM 3.0. Electrical safety per IEC 60601 series. LDCP logic circuit architecture.

Indications for Use

Indicated for adult and pediatric patients requiring panoramic, cephalometric, or cross-sectional imaging of the oral and maxillofacial anatomy for treatment planning.

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

• PaX-Reve3D (K090171)

Submission Summary (Full Text)

{0}------------------------------------------------

K102259

# 510(k) Summary

# FEB 1 8 2011

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

Date

July 29, 2010

## Manufacturer

Vatech Co., Ltd.

23-4, Seogu-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Korea Republic

Tel: [phone]

Fax: [phone]

Contact person: Mr. Choi Hyuk-jun

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

VATECH America.

333 Meadowlands Parkway #303, Secaucus, NJ 07094, USA

Tel: [phone]

Fax: [phone]

Contact person: Mr. Dave Kim

### Trade/Proprietary Name:

PaX-Flex3D

#### Common Name:

Dental Computed Tomography X-ray System

#### Classification Name:

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

Description:

{1}------------------------------------------------

PaX-Flex3D is a diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometric, and computed tomography for implantation. Specifically designed for dental radiography of the teeth or jaws, PaX-Flex3D is equipped with extra-oral x-ray detector, panoramic radiography with an extra-oral x-ray tube, cephalometric radiography and computed tomographic radiography.

The computed tomography is a system based on CMOS digital X-ray detector. CMOS CT detector is used to capture scanned images in 3D for obtaining diagnostic information of teeth for oral surgery or other treatments. The device can also be operated as the panoramic and cephalometirc dental x-ray system based on CMOS X-ray detector.

#### Indication for use:

PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentishy, The device is operated and used by physicians, dentists, and x-ray technicians.

## Predicate Device:

| Manufacturer | : E-WOO Technology Co., Ltd. |
|---------------|---------------------------------------|
| Device | : PaX-Reve3D |
| 510(k) Number | : K090171 (Decision Date - 4/30/2009) |

### Substantial Equivalence:

The PaX-Flex3D described in this 510(k) has the same intended use and similar technical characteristics as PaX-Reve3D of E-WOO Technology Co., Ltd.

| Characteristic | Proposed<br>Vatech Co., Ltd.<br>PaX-Flex3D | Predicate<br>E-WOO Technology Co., Ltd.<br>PaX-Reve3D |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K090171 |
| Indications<br>for use | PaX-Flex3D is a computed<br>tomography x-ray system intended to<br>produce panoramic,<br>cephalometric or cross-sectional<br>images of the oral anatomy on a real<br>time basis by computer<br>reconstruction of x-ray image data<br>from the same axial plane taken at<br>different angles. It provides<br>diagnostic details of the anatomic<br>structures by acquiring 360°<br>rotational image sequences of oral<br>and maxillofacial area for a precise<br>treatment planning in adult and<br>pediatric dentistry. The device is<br>operated and used by physicians,<br>dentists, and x-ray technicians. | PaX-Reve3D is Computed<br>Tomography X-Ray System.<br>Real time - image acquisition.<br>Especially, advanced digital<br>imaging process allows<br>considerably efficient diagnosis,<br>all kind of information<br>management, real-time sharing of<br>image information on network.<br>Furthermore PaX-Reve3D is<br>equipped with the Flat Panel<br>Detector, CT sensor to capture a<br>3D X-ray Computed tomography<br>scanned image. |
| Performance<br>Specification | Panoramic, cephalometric and computed<br>tomography | Panoramic, cephalometric and<br>computed tomography |
| Input Voltage | 110V/230V~ | 110V/220V~ |
| Tube Voltage | 50-90 kV | 40-90kV |
| Tube Current | 4~10 mA | 2-10mA |
| Focal Spot Size | 0.5 mm | 0.5mm |
| Exposure Time | 9 - 24 s | 0.5s-30s (Various) |
| Size of Imaging<br>Volume | 8 x 5 cm | 14 x 12 cm |
| | 5 x 5 cm | 10 x 6 cm |
| | | 5x5 cm |
| Slice Width | 0.1mm min. | 0.1mm min. |
| Total Filtration | 2.8mmAl | 2.8mmAl |
| | 3.3 lp/mm - CT | 2.5 lp/mm - CT |
| Pixel<br>Resolution | 5 lp/mm - Panorama | 4.5 lp/mm - Panorama |
| | 5 lp/mm - Cephalometric | 3.94 lp/mm - Cephalometric |
| | 150 x 150 μm / 200 x 200 μm - CT | 200 μm - CT |
| Pixel Size | 100 x 100 μm - Panorama | 96 μm - Panorama |
| | 100 x 100 μm - Cephalometric | 127 μm - Cephalometric |
| Image Receptor | CT with Flat Panel Detector | CT with Flat Panel Detector |
| Chin Rest | Equipped Headrest | Equipped Headrest |
| Performance<br>Specification | Computed tomography | Computed tomography |
| Mechanical | Compact design | Compact design |
| Electrical | LDCP logic circuit | LDCP logic circuit |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| Anatomical<br>Sites | Maxillofacial | Maxillofacial |

{2}------------------------------------------------

510(k) Submission - PaX-Flex3D

. .

.

.

.

.

.

.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.

.

.

.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

.

:

·

:

{3}------------------------------------------------

510(k) Submission - PaX-Flex3D

The indications for use, material, form factor, performance, and safety characteristics between PaX-Flex3D and the predicate device are the same. The primary difference is size, cosmetic, structure and component used only. Accordingly we can claim the substantially equivalence of PaX-Flex3D to the predicate device.

# Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A1+A2, 1995), 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 60601-2044 (Ed.2+A1, 2002) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.

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

#### 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-Flex3D is safe and effective and substantially equivalent to predicate device as described herein.

END

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes on its wings, symbolizing health, hope, and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

Vatech Co., Ltd. c/o Mr. Dave Kim Medical Device Regulatory Affairs Vatech America 333 Meadowlands Parkway, #303 SECAUCUS NJ 07094

FFB 18 201

Re: K102259

> Trade Name: PaX-Flex3D Regulation Number: 21 CFR § 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 11, 2011 Received: February 15, 2011

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

{5}------------------------------------------------

Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (2) 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 S Postel

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

Enclosure

{6}------------------------------------------------

# Indications for Use

510(K) Number (if known):

Device Name: PaX-Flex3D

Classification: Dental Computed tomography X-ray system

Indications for Use:

PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry . The device is operated and used by physicians, dentists, and x-ray technicians.

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)

---

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K102259
510K

Page 1 of 1