Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard computed tomography image reconstruction and does not mention AI or ML.

Therapeutic

No
The device is used to produce images and provide diagnostic details for precise treatment planning; it does not perform treatment itself.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device "provides diagnostic details of the anatomic structures" and is used for "precise treatment planning." Additionally, the "Device Description" mentions that it is used to "capture radiographic diagnostic images of oral anatomy."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a complete dental X-ray system equipped with hardware components like an x-ray tube, generator, and detector, in addition to software for image reconstruction.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The PHT-6500 is an imaging system that uses X-rays to produce images of the oral anatomy. It does not analyze biological samples taken from the body.
Intended Use: The intended use is to provide diagnostic details of anatomical structures through imaging for treatment planning in dentistry. This is a diagnostic imaging function, not an in vitro diagnostic function.
Device Description: The description clearly states it's a dental radiographic imaging system that uses X-ray technology and detectors to capture images.

Therefore, the PHT-6500 falls under the category of a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

OAS

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.

Mentions image processing

computer reconstruction of x-ray image data from the same axial plane taken at different angles.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography X-ray
Panoramic X-ray
Cephalometric X-ray

Anatomical Site

oral anatomy
oral and maxillofacial area
Maxillofacial

Indicated Patient Age Range

adult and pediatric dentistry

Intended User / Care Setting

physicians, dentists, and x-ray technicians.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121412

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.

Summary

0

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:

+82-31-379-9585 Mr. Sung-Hee Park

Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
(U.S. Designated agent)
Address:	12946 Kimberley Ln, Houston, TX 77079
Telephone:	+713-467-2607
Fax:	+713-464-8880

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,
Class II)
Product Code:	OAS

Vatech Co., Ltd.

1

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

2

| | Table 1. Comparison of PCH-2500 (PaX-i) and PCH-2500 (K113672)
Proposed
Vatech Co., Ltd. | Predicate
Vatech Co., Ltd. |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | PHT-6500 (PHT-60CFO) | PaX-Flex3D (PHT-7000) |
| 510(k) number | - | K121412 |
| 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. | PaX-Flex3D (PHT-7000) 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. |
| Performance
Specification | Panoramic, cephalometric and computed
tomography | Panoramic, cephalometric and computed
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
Sites | Maxillofacial | Maxillofacial |

.

·

:

.

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

:

.

:

.

:

3

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

:

4

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

5

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

6

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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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

7

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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