PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

K113672 · VATECH Co., Ltd. · MUH · Mar 27, 2012 · Dental

Device Facts

• Record ID: K113672
• Device Name: PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
• Applicant: VATECH Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Mar 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

PCH-2500 is digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, and x-ray technicians and other professionals licensed by the law of the state in which the device is used.

Device Story

PCH-2500 is a digital extraoral X-ray imaging system for dental applications. It captures panoramic and cephalometric images of oral and maxillofacial anatomy. The system utilizes dedicated sensors: Xmaru1501CF (panoramic), Xmaru2301CF (cephalometric scan type), and 1210SGA (cephalometric one-shot type). Operated by dentists or X-ray technicians in clinical settings, the device transforms X-ray exposure into digital diagnostic images. These images assist clinicians in treatment planning and diagnostic assessment. The system supports DICOM standards for image communication. It provides a non-invasive method for visualizing dental structures, benefiting patients through improved diagnostic accuracy.

Clinical Evidence

No clinical trials were conducted. Substantial equivalence was supported by non-clinical performance testing, including electrical, mechanical, and environmental safety (IEC 60601 series), EMC testing (IEC 60601-1-2), and image quality performance testing (IEC 61223-3-4 and 61223-3-5). Expert review of image comparisons between the subject and predicate devices was performed.

Technological Characteristics

Extraoral digital X-ray system. Sensors: CMOS photodiode array (panoramic/scan-type ceph) and Amorphous silicon TFT with scintillator (one-shot ceph). Tube voltage: 50-90 kV; Tube current: 4-10 mA; Focal spot: 0.5 mm; Filtration: 2.8 mmAl. Connectivity: DICOM compliant. 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 60601-1-2, NEMA PS 3.1-3.18.

Indications for Use

Indicated for adult and pediatric patients requiring panoramic and cephalometric radiographic imaging of oral and maxillofacial anatomy for diagnostic purposes.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• PaX-Flex3D (K102259)

Submission Summary (Full Text)

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K113672
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# MAR 2 7 2012

510(k) Submission - PCH-2500

# 510(k) Summary

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

#### Date

レ 12/8/2011

## Manufacturer

Vatech Co., Ltd.

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

Tel: [phone] Fax: [phone] Contact person: Mr. Sonny Park

## 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:

PCH-2500

## Common Name:

. Digital X-ray Imaging System

## Classification Name:

System, X-Ray, Extra oral Source, Digital (21CFR 872.1800, Product code MUH, class2)

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## 510(k) Submission - PCH-2500

### Description:

PCH-2500 is a dental digital radiographic imaging system which is available in two different image acquisition modes. Specifically designed for dental radiography of the teeth or jaws, PCH-2500 can be equipped with three dedicated sensors, each for two X-ray modalities : panoramic (Xmarul 501CF), cephalometric scan type (Xmaru2301CF) and oneshot ceph sensor type (1210SGA).

PCH-2500 offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 imaging mode provides a wide range of imaging option based on the customer's diagnostic needs.

#### Indication for use:

PCH-2500 is digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, x-ray technicians and other professionals licensed by the law of the state in which the device is used.

## · Predicate Device:

| Manufacturer | : Vatech Co., Ltd |
|---------------|----------------------------------------|
| Device | : PaX-Flex3D |
| 510(k) Number | : K 102259 (Decision Date - 2/18/2011) |

#### Substantial Equivalence:

PCH-2500 described in this 510(k) has the similar intended use and technical characteristics as PaX-Flex3D of Vatech Co., Ltd.

| Characteristic | Proposed<br>Vatech Co., Ltd.<br>PCH-2500 | Predicate<br>Vatech Co., Ltd.<br>PaX-Flex3D |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K102259 |
| Indications<br>for use | PCH-2500 is digital extra oral<br>source x-ray system intended | PaX-Flex3D is a computed<br>tomography x-ray system intended to |
| | to take panoramic and<br>cephalometric images of the<br>oral and maxillofacial anatomy<br>to provide diagnostic<br>information for adult and<br>pediatric patients. The device<br>should be operated and used<br>by dentists, x-ray technicians<br>and other professionals<br>licensed by the law of the state<br>in which the device is used. | produce 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 plane<br>taken at different angles. It<br>provides diagnostic details of the<br>anatomic 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 and cephalometric | Panoramic and cephalometric<br>and compute tomography |
| Input Voltage | AC 100-120 / 200-240 V | AC 110 / 230 V |
| Tube Voltage | 50-90 kV | 50-90 kV |
| Tube Current | 4-10 mA | 4-10 mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | Max 20.2 s | 9-24 s |
| Total Filtration | 2.8 mmAl | 2.8 mmAl |
| Pixel Resolution | Panoramic : 5 lp/mm | Panoramic : 5 lp/mm |
| | Cephalometric (scan type)<br>5 lp/mm : | Cephalometric (scan type)<br>5 lp/mm : |
| | Cephalometric (one shot type)<br>3.9 lp/mm : | |
| | CT – N/A | CT - 3.3 lp/mm |
| Pixel Size | Panoramic : 100 x 100 µm | Panoramic - 100 x 100 µm |
| | Cephalometric (scan type):<br>100 x 100 µm : | Cephalometric (scan type):<br>100 x 100 µm : |
| Cephalometric (one shot type) | | |
| 127 x 127 µm : | | |
| | CT - N/A | CT : 150 x 150 µm/200 x 200 µm |
| Image Receptor | CMOS photodiode array –<br>panoramic (Xmaru1501CF) &<br>cephalometric<br>(Xmaru2301CF)<br>Amorphous silicon TFT with<br>scintillator – Cephalometric<br>(1210SGA) | CMOS photodiode array –<br>panoramic (Xmaru1501CF) &<br>cephalometric (Xmaru2301CF) |

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## 510(k) Submission – PCH-2500

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#### 510(k) Submission - PCH-2500

Indications for use, safety characteristics, and non-clinical performance for panoramic and cephalometric sensors (scan type) of PCH-2500 and PaX-Flex3D are similar. The primary differences are as follows: PCH-2500 lacks the cone beam CT mode. PCH-2500 offers optional solid state X-ray sensor for cephalometric mode. (The non-clinical performance and clinical consideration report for the SSXI detector, 1210SGA, 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, we can claim the substantial equivalence of PCH-2500 in comparison with PaX-Flex3D, the predicate device, in terms of safety and effectiveness.

#### 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) and IEC 60601-2-32 (Ed. 1, 1994) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.

PCH-2500 also meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.

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## 510(k) Submission - PCH-2500

Clinical considerations according to FDA Guidance Non-clinical & & "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 PCH-2500 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the eagle's feathers. The logo is black and white.

## 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

MAR 2 7 2012

Vatech Co., Ltd. Mr. Dave Kim Official Correspondent Mtech Group 12946 Kimberly Lane HOUSTON TX 77079

Re: K113672

Trade/Device Name: PCH-2500 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH and MOB Dated: February 14, 2012 Received: February 16, 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 mcuirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as set form in the quarty, I device as described in your Section 510(k) premarket will anow you to begin marketing your covivalence of your device to a legally marketed nontication. The I Dr I mailing of succion 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 11 you decire operitio da research 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 Tou may 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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## KIN672

# Indications for Use

510(k) Number(if known):

Device Name: PCH-2500

Classification: System, X-Ray, Extraoral Source, Digital (21 CFR 872.1800, Product code MUH, Class2)

Indications for Use:

PCH-2500 is digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, and x-ray technicians and other professionals licensed by the law of the state in which the device is used.

Prescription Use

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ AND/OR (Part 21 CFR 801 Subpart C)

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

(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety
510K. K113672

Concurrence of CDRH, Office of Device Evaluation(ODE)

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