(91 days)
Not Found
No
The summary describes a portable X-ray system and its components, with no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is used for diagnostic imaging (producing X-ray images) rather than directly treating a disease or condition.
Yes
The device "generates and controls X-ray in order to diagnose of hand, tooth and jaw," and is described as an "extraoral x-ray source for producing diagnostic x-ray images."
No
The device description clearly states it is a portable dental X-ray system with hardware components like an X-ray tubehead, controls, power source, batteries, and a charger, all assembled into a hand-held enclosure. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The PORT-X II Portable X-Ray system is an imaging device that generates X-rays to create images of anatomical structures within the body (hand, tooth, and jaw). It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for producing diagnostic X-ray images using intraoral image receptors, which is an in vivo (within the body) process.
Therefore, based on the provided information, the PORT-X II Portable X-Ray system is a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EHD
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.
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).
- 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:
Without opening Dead Man Controller, shooting X-Ray and continuous shooting should be not operated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
hand, tooth and jaw
Indicated Patient Age Range
adult and pediatric subjects.
Intended User / Care Setting
trained dentists and dental 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)
Not Found
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.
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
§ 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.
0
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
-
- Company and Correspondent making the submission:
Name - GENORAY Co., Ltd.
- Company and Correspondent making the submission:
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 |
-
- Predicate Devices :
| Manufacturer | : Aribex, Inc. |
|---|---|
| Device | : NOMAD Dental X-ray System |
| 510(k) Number | : K051795(Decision Date - Jul. 14. 2005) |
-
- Classifications Names & Citations :
21CFR 872.1800, EHD - Extraoral source x-ray system, Class 2
- Classifications Names & Citations :
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
1
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:
Without opening Dead Man Controller, shooting X-Ray and continuous shooting should be not operated.
6. Indication for use :
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.
-
- Comparison with predicate device :
GENORAY Co., Ltd. believes that the Portable X-Ray System(PORT-X 11) is
- Comparison with predicate device :
#512 Byucksan Technopia 434-6, Sangdaewon1-Dong, Jungwon-Gu, Seongnam-City, Gyeonggi-Do, 462-716, Korea
2
GENORAY Co., Ltd.
substantially equivalent to NOMAD Dental X-ray System of Aribex, Inc ..
-
- 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.
- Safety, EMC and Performance Data :
EMC testing was conducted by EMC Compliance Co., Ltd. in accordance with Standard EN/IEC 60601-1-2(2001). All test results were satisfactory.
-
- 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.
- Conclusions :
-
- GENORAY Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- GENORAY Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
3
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
4
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
5
Indications for Use
510(k) Number(if known):
Device Name: Portable X-Ray System/ PORT-X II
Indications for Use:
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.
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
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