PHT-6500; PHT-60CFO; PAX-I3D

K122606 · Mtechgroup · OAS · Nov 20, 2012 · Radiology

Device Facts

• Record ID: K122606
• Device Name: PHT-6500; PHT-60CFO; PAX-I3D
• Applicant: Mtechgroup
• Product Code: OAS · Radiology
• Decision Date: Nov 20, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

PHT-6500 (PHT-60CFO) 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-6500 (PHT-60CFO) is a dental radiographic imaging system utilizing an X-ray tube, generator, and CMOS digital detector. It captures 360° rotational X-ray sequences to produce panoramic, cephalometric, and cone beam computed tomography (CBCT) images of the oral and maxillofacial anatomy. Operated by physicians, dentists, or X-ray technicians in clinical settings, the device reconstructs image data in real-time. Output images are used by clinicians for diagnostic assessment and treatment planning, such as oral surgery or implants. The system benefits patients by providing detailed 3D anatomical visualization for precise clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated via non-clinical testing per FDA guidance for Solid State X-ray Imaging Devices. Compliance 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) standards. Comparative image review performed by a licensed dentist to verify diagnostic quality against the predicate device. All test results were satisfactory.

Technological Characteristics

Dental CBCT system using CMOS digital X-ray detectors. Features include 50-90 kV tube voltage, 4-10 mA tube current, 0.5 mm focal spot size, and 2.8 mmAl total filtration. Connectivity via DICOM 3.0. Electrical safety per IEC 60601 series. System includes headrest and LDCP logic circuit.

Indications for Use

Indicated for adult and pediatric patients requiring panoramic, cephalometric, or cross-sectional imaging of the oral and maxillofacial anatomy for dental 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-Flex3D (PHT-7000) (K121412)

Submission Summary (Full Text)

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K122606

## Special 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: August 23rd, 2012

Submitter's Name, address, telephone number, a contact person:

Submitter's Name : Submitter's Address:

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

Submitter's Telephone: Contact person:

[phone] Mr. Sung-Hee Park

| Official Correspondent: | Dave Kim ([e-mail]) |
|-------------------------|---------------------------------------|
| (U.S. Designated agent) | |
| Address: | 12946 Kimberley Ln, Houston, TX 77079 |
| Telephone: | [phone] |
| Fax: | [phone] |

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

| Trade/Proprietary Name: | PHT-6500 (PHT-60CFO) |
|-------------------------|---------------------------------------------------------------------------|
| Common Name: | Dental Computed Tomography X-ray System |
| Classification Name: | System, X-ray, Tomography, Computed , Dental(21CFR 892.1750,<br>Class II) |
| Product Code: | OAS |

Vatech Co., Ltd.

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#### Predicate Device:

| Manufacturer: | Vatech Co., Ltd |
|----------------|-----------------------|
| Device Name: | PaX-Flex3D (PHT-7000) |
| 510(k) Number: | K121412 |

#### Device Description:

PHT-6500 (PHT-60CFO), a dental radiographic imaging system, consists of three different image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-6500 (PHT-60CFO) 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:

PHT-6500 (PHT-60CFO) 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.

#### Summary of the technological characteristics of the device compared to the predicate device:

PHT-6500 (PHT-60CFO) described in this special 510(k) submission is substantially equivalent to PaX-Flex3D (K121412) and has the same indications for use and similar technical characteristics as PaX-Flex3D (PHT-7000) of Vatech Co., Ltd. Table 1 summarizes the technological characteristics of the PHT-6500 (PHT-60CFO) vs. the predicate device

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| | Table 1. Comparison of PCH-2500 (PaX-i) and PCH-2500 (K113672)<br>Proposed<br>Vatech Co., Ltd. | Predicate<br>Vatech Co., Ltd. |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | PHT-6500 (PHT-60CFO) | PaX-Flex3D (PHT-7000) |
| 510(k) number | - | K121412 |
| Indications<br>for use | 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 oral<br>anatomy on a real time basis by<br>computer reconstruction of x-ray<br>image data from the same axial<br>plane taken at different angles. It<br>provides diagnostic details of the<br>anatomic structures by acquiring<br>360° rotational image sequences<br>of oral and maxillofacial area for a<br>precise treatment planning in adult<br>and pediatric dentistry . The<br>device is operated and used by<br>physicians, dentists, and x-ray<br>technicians. | PaX-Flex3D (PHT-7000) is a<br>computed tomography x-ray system<br>intended to 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. |
| Performance<br>Specification | Panoramic, cephalometric and computed<br>tomography | Panoramic, cephalometric and computed<br>tomography |
| Input Voltage | AC 100-120/200-240 V | AC 100-120/200-240 V |
| Tube Voltage | 50-90 kV | 50-90 kV |
| Tube Current | $4\sim10$ mA | $2\sim10$ mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | 0.7 - 24 s | 1.9 - 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 |
| Anatomical<br>Sites | Maxillofacial | Maxillofacial |

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Table 1 Comparison of PCH-2500 (PaX-i) and PCH-2500 (K113672)

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| Image Receptor | | Computed<br>Tomography<br>(Flat Panel Detector) | | Xmaru0712CF | Xmaru0712CF |
|---------------------------|------|--------------------------------------------------------|----------------------------|----------------------------|------------------------------------------------------------------------------------|
| | | | | Xmaru1215CF Plus | Xmaru1215CF Plus |
| | | | | Xmaru1215CF Master<br>Plus | - |
| | | Panoramic<br>(CMOS photodiode<br>array) | | Xmaru1501CF | Xmaru1501CF |
| | | Cephalo<br>Metric<br>(CMOS<br>photo<br>diode<br>array) | Scan Type | Xmaru2301CF | Xmaru2301CF |
| | | | One Shot<br>Type | 1210SGA | - |
| | | | | 910SGA | - |
| Size of Imaging<br>Volume | | Xmaru0712CF | | Max. 8 x 8 cm | 5 x 5 cm / 8 x 5 cm / 8 x 8 cm |
| | | Xmaru1215CF Plus | | Max. 12 x 9 cm | 5 x 5 cm / 8 x 5 cm /<br>8.5 x 8.5 cm / 12 x 8.5 cm |
| | | Xmaru1215CF<br>Master Plus | | Max.12 x 9 cm | - |
| | | Xmaru0712CF | | 3.5 lp/mm | 3.5 lp/mm |
| | CT | | Xmaru1215CF Plus | 3.5 lp/mm | 3.5 lp/mm |
| Pixel<br>Resolution | | | Xmaru1215CF<br>Master Plus | | 10.1 lp/mm - full resolution<br>5.0 lp/mm - 2x2 binning<br>2.5 lp/mm - 4x4 binning |
| | Pano | Xmaru1501CF | | 5 lp/mm | 5 lp/mm |
| | | Xmaru2301CF | | 5 lp/mm | 5 lp/mm |
| | Ceph | 910SGA | | 3.9 lp/mm | - |
| | | 1210SGA | | 3.9 lp/mm | - |
| Pixel Size | CT | Xmaru0712CF | | 140 x 140 $μm$ | 140 x 140 $μm$ |
| | | | Xmaru1215CF Plus | 140 x 140 $μm$ | 140 x 140 $μm$ |
| | | Xmaru1215CF<br>Master Plus | | | 49.5 $μm$ - full resolution<br>99 $μm$ - 2x2 binning<br>198 $μm$ - 4x4 binning |
| | Pano | Xmaru1501CF | | 100 x 100 $μm$ | 100 x 100 $μm$ |
| | | Xmaru2301CF | | 100 x 100 $μm$ | 100 x 100 $μm$ |
| | Ceph | 910SGA | | 127 x 127 $μm$ | - |
| | | | 1210SGA | | 127 x 127 $μm$ |

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### Summary of Performance Testing:

Indications for use, safety characteristics, and non-clinical performance for panoramic, cephalometric and CBCT sensors of PHT-6500 (PHT-60CFO) and PaX-Flex3D (PHT-7000) are similar. The primary differences are as follows: PHT-6500 (PHT-60CFO) introduces one new cone beam CT sensor, Xmaru1215CF Master Plus, and two new cephalo sensors (One Shot type), 910SGA and 1210SGA. The non-clinical performance and clinical consideration report for the new SSXI sensors are provided separately in this submission. Based on the non-clinical and clinical consideration and the outcome of a comparative review by a licensed dentist of images from both devices, PHT-6500 (PHT-60CFO) is substantially equivalent, in terms of safety and effectiveness, with PaX-Flex3D (PHT-7000), 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.

PHT-6500 (PHT-60CFO) 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 PHT-6500 (PHT-60CFO) 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 and Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO-66 Silver Spring, MD 20993-002

November 20, 2012

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

Re: K122606

Trade/Device Name: PHT-6500 (PHT-60CFO) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: October 22, 2012 Received: October 25, 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 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

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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.

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 Diagnostics and Radiological Health 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, J

# Janine M. Morris -S

Janine M. Morris 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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510(k) Number (if known): K122606

Device Name: PHT-6500 (PHT-60CFO)

Classification: System, X-ray, Tomography, Computed, Dental (21 CFR 892.1750, Product Code OAS, Class II)

Indications for Use:

PHT-6500 (PHT-60CFO) 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 X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Janine M. Morris -5 2012.11.20 15:36:58 -05'00'

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) **K122606**

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