Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart

K152106 · VATECH Co., Ltd. · OAS · Oct 23, 2015 · Radiology

Device Facts

• Record ID: K152106
• Device Name: Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
• Applicant: VATECH Co., Ltd.
• Product Code: OAS · Radiology
• Decision Date: Oct 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

PHT-30LFO 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

PHT-30LFO is a dental radiographic imaging system (panoramic, cephalometric, CBCT) using CMOS digital X-ray detectors. It acquires 360-degree rotational X-ray sequences of the oral/maxillofacial area. Data is processed via an iterative reconstruction algorithm to reduce noise compared to standard filtered back projection. Operated by physicians, dentists, or technicians in clinical settings. Output consists of 2D/3D images viewed via EasyDent (2D) and Ez3D Plus (3D) software on a PC. Images assist in treatment planning for oral surgery and implants. Benefits include precise anatomical visualization and reduced noise in CT images.

Clinical Evidence

Bench testing only. Performance evaluated via MTF, DQE, and NPS metrics for new detectors (Xmaru1404CF, Xmaru2301CF-O) compared to predicate sensors. Clinical images were qualitatively compared to predicate device images to confirm system functionality. Compliance with IEC 60601-1, 60601-1-3, 60601-2-63, and 60601-1-2 standards demonstrated.

Technological Characteristics

Dental CBCT system using CMOS digital X-ray detectors. Input voltage 100-240V. Features iterative reconstruction algorithm. Connectivity via DICOM 3.0. PC-based system (Intel Xeon, 16GB RAM, NVIDIA GTX 780 Ti). Standards: IEC 60601-1 (Ed. 3), IEC 60601-1-3 (Ed. 2), IEC 60601-2-63 (Ed. 1), IEC 60601-1-2, NEMA PS 3.1-3.18.

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 in dentistry.

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

• PHT-6500 (K122606)

Submission Summary (Full Text)

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

October 23, 2015

Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K152106

Trade/Device Name: PaX-i3D Smart (PHT-30LFO) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: July 24, 2015 Received: July 29, 2015

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. 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.

Michael D'Hara

For

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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# Indications for Use

510(k) Number (if known) K152106

Device Name PHT-30LFO PaX-i3D Smart

Indications for Use (Describe)

PHT-30LFO 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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# Traditional 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

# Date 510K summary prepared: July 24, 2015

### I. SUBMITTER

| Submitter's Name : | Vatech Co., Ltd. |
|----------------------------------------------------|--------------------------------------------------------------------------------|
| Submitter's Address: | 13, Samsung 1-ro 2-gil, Hwaseong-Si, Gyeonggi-Do, 445-170<br>Republic of Korea |
| Submitter's Telephone: | [phone] |
| Contact person: | Mr. Daniel.Kim |
| Official Correspondent:<br>(U.S. Designated agent) | Dave Kim ([e-mail]) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | [phone] |
| Fax: | [phone] |

### II. DEVICE

| Trade/Proprietary Name: | PaX-i3D Smart (PHT-30LFO) |
|-------------------------|-----------------------------------------|
| Common Name: | Dental Computed Tomography X-ray System |
| Regulation Name: | Computed Tomography X-ray System |
| Classification: | (21CFR 892.1750, Class II) |
| Product Code: | OAS |

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#### III. PREDICATE DEVICE

| Primary Manufacturer: | Vatech Co., Ltd |
|-----------------------|----------------------------------|
| Device Name: | PHT-6500 |
| Regulation Name : | Computed Tomography X-ray System |
| Classification No : | 21CFR 892.1750, Class II |
| Product Code: | OAS |
| 510(k) Number: | K122606 |

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

#### DEVICE DESCRIPTION IV.

PHT-30LFO, a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometric and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-30LFO is a complete dental X-ray system equipped with x-fay 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.

## System's Kev Components:

- PHT-30LFO digital x-ray equipment with SSXI detectors (Xmaru1404CF, Xmaru2301CF, . Xmaru2301CF-O, 910SGA, 1210SGA)
- . PC system
- > CPU: IntelXeon E5-1607 3GHz, 1600 4C or faster
- RAM: 16GB DDR3-1600 ECC RAM / UDIMM A
- > Hard disk drive: 1 TB SATA 1st HDD
- > Graphic board: ZOTAC NVIDIA Geforce GTX 780 Ti AMP! D5 3GB
- Imaging software ●
- > EasyDent: 2D viewer and patient management software
- > Ez3D Plus : 3D viewer and image analysis software

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#### INDICATIONS FOR USE: v.

PHT-30LFO 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 xray 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.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

| | Proposed | Predicate | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Vatech Co., Ltd. | Vatech Co., Ltd. | |
| | PHT-30LFO (PaX-i3D Smart) | PHT-6500 (PHT-60CFO) | |
| 510(k) number | K152106 | K122606 | |
| Indications<br>for use | PHT-30LFO is a computed<br>tomography x-ray system<br>intended to produce panoramic,<br>cephalometric or cross-<br>sectional images of the oral<br>anatomy on a real time basis by<br>computer reconstruction of x-<br>ray image data from the same<br>axial plane taken at different<br>angles. It provides diagnostic<br>details of the anatomic<br>structures by acquiring 360°<br>rotational image sequences of<br>oral and maxillofacial area for a<br>precise treatment planning in<br>adult and pediatric dentistry .<br>The device is operated and used<br>by physicians, dentists, and x-<br>ray technicians. | PHT-6500 (PHT-60CFO) is a<br>computed tomography x-ray<br>system intended to produce<br>panoramic, cephalometric or<br>cross-sectional images of the<br>oral anatomy on a real time<br>basis by computer<br>reconstruction of x-ray image<br>data from the same axial plane<br>taken at different angles. It<br>provides diagnostic details of<br>the anatomic structures by<br>acquiring 360° rotational image<br>sequences of oral and<br>maxillofacial area for a precise<br>treatment planning in adult and<br>pediatric dentistry . The device<br>is operated and used by<br>physicians, dentists, and x-ray<br>technicians. | |
| Performance Specification | Panoramic,<br>cephalometric<br>and<br>computed tomography | Panoramic,<br>cephalometric<br>and<br>computed tomography | |
| Input Voltage | AC 100-240 V | AC 100-120/200-240 V | |
| Tube Voltage | 50-99 kV | 50-90 kV | |
| | | | |
| Tube Current | | 4 ~16 mA | 4 ~10 mA |
| Focal Spot Size | | 0.5 mm | 0.5 mm |
| Exposure Time | | Max. 18 s | 0.7 - 24 s |
| Slice Width | | 0.1 mm min. | 0.1 mm min. |
| Total Filtration | | 2.8 mmAl | 2.8 mmAl |
| Chin Rest | | Equipped Headrest | Equipped Headrest |
| Mechanical | | Compact design | Compact design |
| Electrical | | LDCP logic circuit | LDCP logic circuit |
| Software | | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| 2D Image Viewing<br>Program | | EasyDent | EasyDent |
| 3D Image Viewing<br>Program | | Ez3D Plus | Ez3D Plus |
| Anatomical Sites | | Maxillofacial | Maxillofacial |
| | Computed<br>Tomography | Xmaru1404CF | Xmaru0712CF |
| | | | Xmaru1215CF Plus |
| | | | Xmaru1215CF Master Plus |
| Image | Panoramic | Xmaru1404CF | Xmaru1501CF |
| Receptor | Cephalometric | Xmaru2301CF | Xmaru2301CF |
| | | 1210SGA | 1210SGA |
| | | 910SGA | 910SGA |
| | | Xmaru2301CF-O | |
| Size of Imaging Volume<br>(cm) | | Xmaru1404CF : Max. 10x8.5 | Xmaru0712CF : Max. 8x8 |
| | | | Xmaru1215CF Plus : Max.<br>12x9 |
| | | | Xmaru1215CF Master Plus :<br>Max. 12x9 |
| | Computed<br>Tomography | Xmaru1404CF :<br>- 5.0 lp/mm - 2x2 binning<br>- 2.5 lp/mm - 4x4 binning | Xmaru0712CF : 3.5 lp/mm |
| | | | Xmaru1215CF Plus : 3.5 lp/mm |
| Pixel<br>Resolution | | | Xmaru1215CF Master Plus :<br>- 5.0 lp/mm - 2x2 binning<br>- 2.5 lp/mm - 4x4 binning |
| | Panoramic | Xmaru1404CF :<br>- 5.0 lp/mm - 2x2 binning<br>- 2.5 lp/mm - 4x4 binning | Xmaru1501CF :<br>5 lp/mm |
| | | | |
| | Cephalometric | Xmaru2301CF : 5 lp/mm | Xmaru2301CF : 5 lp/mm |
| | | 1210SGA : 3.9 lp/mm | 1210SGA : 3.9 lp/mm |
| | | 910SGA : 3.9 lp/mm | 910SGA : 3.9 lp/mm |
| | | Xmaru2301CF-O : 5 lp/mm | |
| Pixel Size | Computed<br>Tomography | Xmaru1404CF :<br>- 99 $\mu$ m- 2x2 binning<br>- 198 $\mu$ m- 4x4 binning | Xmaru0712CF : 140 × 140 $\mu$ m<br>Xmaru1215CF Plus : 140 × 140<br>$\mu$ m<br>Xmaru1215CF Master Plus :<br>- 99 $\mu$ m- 2x2 binning<br>- 198 $\mu$ m- 4x4 binning |
| | Panoramic | Xmaru1404CF :<br>- 99 $\mu$ m- 2x2 binning<br>- 198 $\mu$ m- 4x4 binning | Xmaru1501CF:<br>100 × 100 $\mu$ m |
| | Cephalometric | Xmaru2301CF : 100 × 100 $\mu$ m | Xmaru2301CF : 100 × 100 $\mu$ m |
| | | 1210SGA : 127 × 127 $\mu$ m | 1210SGA : 127 × 127 $\mu$ m |
| 910SGA : 127 × 127 $\mu$ m | | 910SGA : 127 × 127 $\mu$ m | |
| Xmaru2301CF-O : 100 × 100 $\mu$ m | | | |

The PHT-30LFO dental CBCT system described in this 510(k) has the similar intended use and technical characteristics as the PHT-6500 of Vatech Co.,Ltd.

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510(k) Submission – PHT-30LFO

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#### VII. PERFORMANCE DATA

## Summary of Performance Testing:

The PHT-30LFO dental CBCT system described in this 510(k) is similar to the predicate device in its indications for use, materials, safety characteristics, X-ray source.

Moreover, the following information further substantial equivalence between two devices:

The fundamental technological characteristics of the subject and predicate device are similar.

Laboratory and clinical performance…