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 Description

The PaX-Uni3D diagnostic equipment consists of Digital Computed Tomography, Panoramic, and Cephalometric dental X-ray system. This device is a system based on Digital X-ray Imaging System (Computed Tomography Sensor to Capture X-ray Digital Computed Tomogram Scanned Image)

AI/ML Overview

The provided document is a 510(k) summary for a dental X-ray imaging system (PaX-Uni3D). It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or algorithm performance.

The safety and effectiveness data mentioned in section 8 refers to compliance with electrical, mechanical, environmental, and EMC standards (IEC 60601 series). This is standard for medical devices but does not involve AI performance evaluation.

Therefore, I cannot provide the requested table and study details as the information is not present in the provided text. The document focuses on showing substantial equivalence to a predicate device based on general safety and performance standards for an imaging system, not on the performance of a diagnostic algorithm or AI.

Summary

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K090467

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 892.1750.

Date: November 4, 2009

'JAN ~ 8 2010

Company and Correspondent making the submission:

Name: Vatech Co., Ltd.

23-4, Seogu-Dong, Hwaseong-si, Gyeonggi-do, 445-170, Address: Korea

Telephone: +82-31-377-9104

Fax: +82-31-337-1882

Contact: Mr. DongTaek, Oh

Internet: http://www.vatech.co.kr
1. Device :

Trade/proprietary name	: PaX-Uni3D
Common Name	: Digital X-ray imaging system
Classification Name	: X-ray, tomography, computed, dental

1. Predicate Device :

Manufacturer	: Vatech Co., Ltd.
Device	: PaX-500
510(k) Number	: K082350 (Decision Date - Oct. 10. 2008)

Classifications Names & Citations :

21CFR 892.1750, OAS, X-ray, tomography, computed, dental, Class2

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5. Description :

5.1 General

5.2 Product features

1). Condition of Input

·Rated input voltage: AC 220V

·Guaranteed working voltage
-110V Mode: 100 ~120V / 220V Mode: 200 ~240V

•Possible working voltage

-110V Mode : 90 ~130V / 220V Mode : 180 ~ 250V

·Rated input frequency: 50Hz/60Hz

•Insulation withstanding: below than 1.5KV cap for more than one minute

between first test and second test.

2) Capture mode

•Panoramic System
2-1 Standard Mode
Standard Panoramic
V Hemi-Panoramic (Left and Right)
Frontal Dentition
V Sinus
TMJ open/Close mouth: 4 views
2-2 Special Mode
- Incisor clear >
- V Orthogonal
- V Canal clear
- Maxillary Molar clear

Vatech Co., Ltd.

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Image /page/2/Picture/1 description: The image contains two dental x-rays, one labeled "Standard Panoramic" and the other labeled "Canal clear". The "Standard Panoramic" x-ray shows a full view of the teeth and jaw. The "Canal clear" x-ray shows a close-up view of a specific tooth or area of the mouth.

•Capture modes of Cephalometric System

√ Latero-Lateral [Lateral Mode]
V Posterior Anterior [PA Mode]
/ Carpus
V SMV

Image /page/2/Picture/7 description: The image contains two X-ray images of a human skull. The image on the left shows a side view of the skull, while the image on the right shows a front view. The X-rays reveal the bone structure of the skull, including the cranium, facial bones, and teeth. The images are grayscale and have a grainy texture.

Tomography
- √ Shooting Mode : Mandible/ Maxillary/ Occlusion/ TMJ
- √ Shooting Range : All kind of tooth
- ✔ Basic Display View : View Available

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< Reference Panorama View : Available
V 3D Image
- -Standard Viewer
- -Professional Viewer
1. Indication for use :

Comparison with predicate device :

Vatech Co., Ltd., believes that the PaX-Uni3D is substantially equivalent to the PaX-500 of Vatech Co., Ltd.

1. Safety, EMC and Performance Data :
  Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 and IEC 60601-2-44 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. All test results were satisfactory.
1. 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 The PaX-Uni3D is safe and effective and substantially equivalent to predicate devices as described herein.
1. Vatech Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.

END

Vatech Co., Ltd.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

JAN - 8 2010

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

VATECH Co., Ltd. % Mr. Vincent Lee Product Compliance Officer E-WOO Technology USA Inc. 256 North Sam Houston Pkwy E. #115 HOUSTON TX 77060

Re: K090467

Trade/Device Name: PaX-Uni3D Regulation Number: 21 CFR 872.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: November 4, 2009 Received: November 13, 2009

Dear Mr. Lee:

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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number(if known):

K090467

Device Name: PaX-Uni3D

Classification: X-Ray, Tomography, Computed, Dental

Indications for Use:

Prescription Use_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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)

Here is the JSON requested:

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

Page 1 of _1

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.