The PORT-X II Portable X-Ray system is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Device Description

PORT-X II is a portable dental X-ray system that operates on 22.2VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes spare batteries, a battery charger. This equipment generates and controls X-ray in order to diagnose of hand, tooth and jaw. It is composed of X-ray generator, controller and beam limiting device.

AI/ML Overview

The provided 510(k) summary for the GENORAY Co., Ltd. Portable X-Ray System (PORT-X II) primarily focuses on establishing substantial equivalence to a predicate device and demonstrating compliance with safety and performance standards rather than presenting a detailed study with specific acceptance criteria related to diagnostic accuracy or clinical effectiveness. Therefore, many of the requested criteria for a study proving device performance are not explicitly available in the provided text.

Here's an analysis based on the information given, and where information is missing, it will be noted.

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or device performance related to image quality or clinical outcomes. Instead, it focuses on compliance with established safety and electrical standards.

Acceptance Criteria (Derived from Compliance)	Reported Device Performance
Compliance with UL/IEC 60601-1 (General medical electrical equipment safety)	Will comply (stated intention)
Compliance with IEC 60601-2-7 (Medical electrical equipment - X-ray generators for diagnostic use)	Will comply (stated intention)
Compliance with IEC 60601-2-28 (Medical electrical equipment - Diagnostic X-ray source assemblies)	Will comply (stated intention)
Compliance with IEC 60601-2-32 (Medical electrical equipment - X-ray equipment for general use)	Will comply (stated intention)
Compliance with EN/IEC 60601-1-2(2001) (EMC for medical electrical equipment)	All test results were satisfactory (by EMC Compliance Co., Ltd.)
Leakage Current of External Body meets IEC 60601-1 requirement	Should be satisfied (stated design feature)
X-ray Shooting Controller: Dead Man Type function	Shooting of X-Ray and continuous shooting should not be operated without opening Dead Man Controller (stated design feature)
Buzzer sound during radiation shooting, off when stopped	Buzzer makes sound during shooting, turned off when stopped (stated design feature)

2. Sample sized used for the test set and the data provenance

The document does not describe a clinical test set for evaluating the diagnostic performance of the device or human reader performance. The testing mentioned relates to electrical safety and EMC compliance, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical test set with ground truth established by experts is described.

4. Adjudication method for the test set

Not applicable, as no clinical test set with ground truth requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a portable X-ray system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a portable X-ray system, not an algorithm.

7. The type of ground truth used

For the safety and performance evaluations mentioned, the "ground truth" is adherence to established international standards (e.g., IEC 60601 series, EN/IEC 60601-1-2). These are engineering and electrical standards, not medical ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable. This device is a hardware X-ray system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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GENORAY Co., Ltd.

Kola3121 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: September 4, 2006

JAN 1 1 2007

1. Company and Correspondent making the submission:
  Name - GENORAY Co., Ltd.

Address - #512 Byucksan Technopia 434-6, Sangdaewon1-Dong, Jungwon-Gu, Seongnam-City, Gyeonggi-Do, 462-716, Korea Telephone - +82-31-737-8020 Fax – +82-31-737-8025 Contact - Yong Jin Park / Engineer E-mail - yjpark@genoray.com

Device :

Trade/proprietary name	: Portable X-Ray System/PORT-X II
Common Name	: Portable X-Ray System
Classification Name	: Extraoral source x-ray system

1. Predicate Devices :

Manufacturer	: Aribex, Inc.
Device	: NOMAD Dental X-ray System
510(k) Number	: K051795(Decision Date - Jul. 14. 2005)

1. Classifications Names & Citations :
  21CFR 872.1800, EHD - Extraoral source x-ray system, Class 2

5. Description :

5.1 General
PORT-X II is a portable dental X-ray system that operates on 22.2VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray tubehead, X-ray controls, and power

#512 Byucksan Technopia 434-6, Sangdaewon1-Dong, Jungwon-Gu, Seongnam-City, Gyeonggi-Do, 462-716, Korea

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GENORAY Co., Ltd.

source are assembled into a single hand-held enclosure. The package includes spare batteries, a battery charger.

5.2 Outline

This equipment generates and controls X-ray in order to diagnose of hand, tooth and jaw.

It is composed of X-ray generator, controller and beam limiting device.

800年会になる最後のアフェアム『

Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates hand, tooth and jaw, and makes X-ray images on receptor (Chemical Film or Digital Sensor).

5.3 Operating Principle

Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates hand, tooth and jaw, and makes X-ray images on receptor (Chemical Film or Digital Sensor).

5.4 Features

Leakage Current of External Body should be satisfied with the Leakage Current Requirement of IEC 60601-1.
When the Radiation is shooting, buzzer makes sound. And then, when the shooing is Stopped, the sound is turned off.
X-Ray Shooting Controller: < Dead Man Type>

Without opening Dead Man Controller, shooting X-Ray and continuous shooting should be not operated.

6. Indication for use :

1. Comparison with predicate device :
  GENORAY Co., Ltd. believes that the Portable X-Ray System(PORT-X 11) is

#512 Byucksan Technopia 434-6, Sangdaewon1-Dong, Jungwon-Gu, Seongnam-City, Gyeonggi-Do, 462-716, Korea

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GENORAY Co., Ltd.

substantially equivalent to NOMAD Dental X-ray System of Aribex, Inc ..

1. Safety, EMC and Performance Data :
  The portable x-ray system, PORT-X II, will comply with applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32. All required documents and reports will be submitted to the appropriate oversight agency to establish compliance with the applicable requirements.

EMC testing was conducted by EMC Compliance Co., Ltd. in accordance with Standard EN/IEC 60601-1-2(2001). All test results were satisfactory.

1. Conclusions :
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification GENORAY Co., Ltd. concludes that the Portable X-Ray System(PORT-X II) is safe and effective and substantially equivalent to predicate devices as described herein.
1. GENORAY Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

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Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center consists of three curved lines that resemble a stylized human figure.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

GENORAY Co., Ltd. % Mr. Marc M. Mouser Senior Project Engineer, Medical Devices Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

JAN 1 1 2007

Re: K063121

Trade/Device Name: Portable X-Ray System/PORT-X II Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: December 22, 2006 Received: December 26, 2006

Dear Mr. Mouser:

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 Corneric 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. TTo grateral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affective 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.

Image /page/3/Picture/10 description: The image shows a circular logo with the letters "PA" in the center. Above the letters, the numbers "1906-2006" are displayed. Below the letters, the word "Centennial" is written in a cursive font. Three stars are located at the bottom of the logo.

Protecting and Promoting Public Health

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Page 2 -

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); 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,

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours.

Nancy C. Hogdon

Nancy C. Brogdon 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):

K063121

Device Name: Portable X-Ray System/ PORT-X II

Indications for Use:

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

David A. Seggerman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 2063121

Page 1 of 1

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

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