PAX-UNI3D, PHT-7500

K121400 · VATECH Co., Ltd. · OAS · Aug 28, 2012 · Radiology

Device Facts

• Record ID: K121400
• Device Name: PAX-UNI3D, PHT-7500
• Applicant: VATECH Co., Ltd.
• Product Code: OAS · Radiology
• Decision Date: Aug 28, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

Device Story

PaX-Uni3D (PHT-7500) is a dental radiographic imaging system providing panoramic, cephalometric, and cone beam computed tomography (CBCT) modes. The system utilizes an X-ray tube, generator, and CMOS digital X-ray detectors to capture 3D radiographic images of oral anatomy. Operated by dental professionals in clinical settings, the device reconstructs X-ray transmission data from multiple angles into cross-sectional images. These images assist clinicians in planning oral surgery or dental implants. The system is DICOM 3.0 compatible, allowing integration into standard dental imaging workflows. The primary benefit is improved diagnostic visualization of teeth, jaw, and oral structures.

Clinical Evidence

Non-clinical performance testing included electrical, mechanical, and environmental safety (IEC 60601 series) and EMC testing (IEC 60601-1-2). Image quality was validated through non-clinical and clinical consideration reports and expert review of image comparisons against the predicate. No specific clinical trial metrics (e.g., sensitivity/specificity) were reported; substantial equivalence was established via bench testing and comparative imaging analysis.

Technological Characteristics

Dental CBCT system using CMOS photodiode array detectors. Tube voltage: 50-90 kV; Tube current: 2-10 mA; Focal spot: 0.5 mm. Connectivity: DICOM 3.0 compatible. Standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-2-44, IEC 60601-1-2, NEMA PS 3.1-3.18, IEC 61223-3-4, IEC 61223-3-5.

Indications for Use

Indicated for dental examination and diagnosis of diseases of the teeth, jaw, and oral structure in patients requiring panoramic, cephalometric, or cross-sectional imaging.

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-Uni3D (K090467)

Reference Devices

• 1210SGA (K113630)

Submission Summary (Full Text)

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# Special 510(k) Summary

## AUG 2 8 2012

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

Date

May 2, 2012

### Manufacturer

Vatech Co., Ltd.

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

Tel: [phone] Fax: [phone]

Contact person: Park Sung-Hee

#### Official Correspondent (U.S. Designated agent)

Mtech Group 12946 Kimberley Ln, Houston, TX 77079 Tel: [phone] Fax: [phone] Contact person: Mr. Dave Kim ([e-mail])

### Trade/Proprietary Name:

PaX-Uni3D (PHT-7500)

#### Common Name: .

Digital X-ray Imaging System

### Classification Name:

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

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## Description:

PaX-Uni3D (PHT-7500), a dental radiographic imaging system, consists of dual image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Uni3D (PHT-7500) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector.

#### Indication for use:

The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

## Predicate Device:

| Manufacturer | : Vatech Co., Ltd |
|---------------|-------------------------------------------|
| Device | : PaX-Uni3D |
| 510(k) Number | : K090467 (Decision Date -- Jan. 8, 2010) |

#### Substantial Equivalence:

PaX-Uni3D (PHT-7500) described in this 510(k) has the similar intended use and technical characteristics as PaX-Uni3D of Vatech Co., Ltd.

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## 510(k) Submission – PaX-Uni3D (PHT-7500)

| Characteristic | Proposed<br>Vatech Co., Ltd.<br><i>PaX-Uni3D</i> (PHT-7500) | Predicate<br>Vatech Co., Ltd.<br><i>PaX-Uni3D</i> |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K090467 |
| Indications<br>for use | The <i>PaX-Uni3D</i> is a computed<br>tomography x-ray system which<br>is a diagnostic x-ray system<br>intended to produce panoramic,<br>cephalometric and cross-sectional<br>images for dental examination and<br>diagnosis of diseases of the teeth,<br>jaw and oral structure by<br>computer reconstruction of x-ray<br>transmission data from the same<br>axial plane taken at different<br>angles. | The <i>PaX-Uni3D</i> is a computed<br>tomography x-ray system which<br>is a diagnostic x-ray system<br>intended to produce panoramic,<br>cephalometric and cross-sectional<br>images for dental examination and<br>diagnosis of diseases of the teeth,<br>jaw and oral structure by<br>computer reconstruction of x-ray<br>transmission data from the same<br>axial plane taken at different angles. |
| Performance<br>Specification | Panoramic, cephalometric and computed<br>tomography | Panoramic, cephalometric and computed<br>tomography |
| Input Voltage | AC 100-120 / 200-240 V | AC 110/230 V |
| Tube Voltage | 50-90 kV | 40-90 kV |
| Tube Current | 2~10 mA | 2~10 mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | Max 20.2s (Pano)<br>15s/24s selectable (CT)<br>0.9-1.2s (Ceph) | 0.5-12.7s |
| Total Filtration | 2.8 mmAl | 2.8 mmAl |
| Performance<br>Specification | Dental Computed tomography | Dental Computed tomography |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| Anatomical<br>Sites | Maxillofacial | Maxillofacial |

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| Characteristic of detector | | | Proposed<br>PaX-Uni3D (PHT-7500) | Predicate<br>PaX-Uni3D |
|----------------------------|------------------------------------------------------|--------------------------|----------------------------------------------------|------------------------|
| Image Receptor | Computed<br>Tomography<br>(CMOS photodiode<br>array) | | Xmaru0712CF | |
| | Panoramic<br>(CMOS photodiode<br>array) | | Xmaru1215CF Plus | Xmaru0808CF |
| | Cephalometric<br>(Flat Panel Detector) | | Xmaru1501CF | S7199-01 |
| Size of Imaging<br>Volume | | | 1210SGA | Xmaru1210 |
| | Xmaru0712CF | | 5 x 5 cm / 8 x 5 cm / 8 x 8 cm | |
| | Xmaru1215CF Plus | | 5 x 5 cm / 8 x 5 cm /<br>8.5 x 8.5 cm /12 x 8.5 cm | |
| | Xmaru0808CF | | - | 5 x 5 cm / 8 x 5 cm |
| Pixel<br>Resolution | CT | Xmaru0712CF | 3.5 lp/mm | - |
| | | Xmaru1215CF Plus | 3.5 lp/mm | - |
| | | Xmaru0808CF | - | 3.3 lp/mm |
| | Pano | Xmaru1501CF | 5 lp/mm | - |
| | | S7199-01 | - | 10.43 lp/mm |
| | Ceph | 1210SGA (FDA<br>K113630) | 3.9 lp/mm | - |
| | | Xmaru1210 | - | 3.9 lp/mm |
| Pixel Size | CT | Xmaru0712CF | 140 x 140 μm | - |
| | | Xmaru1215CF Plus | 140 x 140 μm | - |
| | | Xmaru0808CF | - | 150 x 150 μm |
| | Pano | Xmaru1501CF | 100 x 100 μm | - |
| | | S7199-01 | - | 48 x 48 μm |
| | Ceph | 1210SGA (FDA<br>K113630) | 127 x 127 μm | - |
| | | Xmaru1210 | - | 127 x 127 μm |

510(k) Submission - PaX-Uni3D (PHT-7500)

The indications for use, material, form factor, performance, and safety characteristics between PaX-Uni3D (PHT-7500) and the predicate device are the same. The primary differences are as follows: PaX-Uni3D (PHT-7500) introduces four new SSXI sensors: Xmaru0712CF and Xmaru1215CF Plus for CT mode, 1210SGA for Cephalometric mode and Xmaru1,501CF for panoramic mode.

:

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The non-clinical performance and clinical consideration report for the new SSXI CBCT sensors are provided separately in this submission. Based on the non-clinical and clinical consideration and the outcome of an expert review of image comparisons for both devices, new PaX-Uni3D (PHT-7500) is substantially equivalent, in terms of safety and effectiveness, with PaX-Uni3D, 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 60601-1-1 (2001), IEC 60601-1-3 (Ed. 1, 1994), IEC 60601-2-7 (1998), IEC 60601-2-28 (Ed. 1, 1993), IEC 60601-2-32 (Ed. 1, 1994) and IEC 60601-2-44 (Ed. 2, 2002) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.

PaX-Uni3D (PHT-7500) meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.

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

Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5 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-Uni3D (PHT-7500) is safe and effective and substantially equivalent to predicate device as described herein.

#### END

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Image /page/5/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 design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular fashion around the bird image.

## 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

· AUG 2 8 2012

Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberley Lane HOUSTON TX 77079

Re: K121400

Trade/Device Name: PaX-Uni3D (PHT-7500) Regulation Number: · 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: July 30, 2012 Received: August 1, 2012

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 (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice mountal device related ad retor e vality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in the quality as described in your Section 510(k) premarket motification. 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 If you ucare specific an 100 for your urro 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 Tou inal 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,

Janine M. Morris

Acting 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-Uni3D (PHT-7500)

.

Classification: System, X-ray, Tomography, Computed, Dental

Indications for Use:

The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

Prescription Use_ (Part 21 CFR 801 Subpart D)

. Over-The-Counter Use AND/OR (P art 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 Division of Naciological Evaluation and Safety

K121460
510K

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