(170 days)
No
The summary describes a standard portable X-ray system and its accessories. There is no mention of AI, ML, or any image processing capabilities that would suggest the use of such technologies. The performance studies focus on physical parameters and safety standards of the X-ray equipment itself.
No
The device is described as an X-ray system used for producing diagnostic images, not for treating diseases or conditions.
No
The device is described as an X-ray source for producing diagnostic images, but it does not perform the diagnosis itself.
No
The device description explicitly states it is a "portable X-ray system" and includes hardware components like a battery, recharging unit, and hand switch, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PORT-X IV is an X-ray system. It uses radiation to create images of the internal structures of the body (specifically teeth and surrounding areas in this case). It does not analyze biological samples.
- Intended Use: The intended use is to produce diagnostic X-ray images, which is a form of medical imaging, not in vitro testing.
The description clearly indicates it's an imaging device used for diagnosis through visual interpretation of X-ray images, not through the analysis of biological specimens.
N/A
Intended Use / Indications for Use
PORT-X IV is a portable X-ray system to be used by trained dental technicians as a mobile, extra oral x-ray source for producing diagnostic x-ray images using intra oral image receptors. It is intended for both adult and pediativ subjects.
Product codes
EHD
Device Description
The portable X-Ray system, PORT-X IV, 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. It is the X-ray equipment and uses it to diagnose the patient to acquire images. It also includes accessories, which are battery, recharging unit and hand switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
both adult and pediatric subjects
Intended User / Care Setting
trained dental technicians, trained dentists
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)
- Electrical, mechanical, environmental safety and performance testing which are mentioned in the standard IEC 60601-1, IEC 60601-1-3 and IEC 60601-2-65 were performed.
- EMC testing was conducted in accordance with standard IEC 60601-1-2.
- Performance testing performed according to FDA 21 CFR 1020.30, 21 CFR 1020.31 standards, Software Validation, Clinical Evaluation. All test results were satisfactory.
The performance test for the subject device, PORT-X IV and the predicate device, REXTAR X(K132041) confirmed that the focal spot to skin distance of both devices were longer than the minimum length of 18 cm in accordance with Federal Standard (21CFR 1020.30 and 31) requirements. Also minimum HVL (half-value layer) of both devices were 1.5 mm in accordance with Federal Standard (21CFR 1020.30 and 31) requirements. Accuracy of loading factors and reproducibility of AIR KERMA for both devcies also met the essential performance requirements in accordance with IEC 60601-1 (ex.
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
GENORAY Co., Ltd. % Mr. Chris Yoon Business Development Manager Genoray America Inc. 147 E. Bristol Lane ORANGE CA 92865
March 7, 2018
Re: K172810
Trade/Device Name: PORT-X IV Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: January 9, 2018 Received: February 12, 2018
Dear Mr. Yoon:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Robert Sauer
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172810
Device Name PORT-X IV
Indications for Use (Describe)
PORT-X IV is a portable X-ray system to be used by trained dental technicians as a mobile, extra oral x-ray source for producing diagnostic x-ray images using intra oral image receptors. It is intended for both adult and pediativ subjects.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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Exhibit 5 510(k) Summary
Date of Summary Preparation: Aug. 11, 2017
| 1. Submitter and US Official Correspondent | |
|---|---|
| Submitter : | GENORAY Co., Ltd. |
| Address: | 512, 560, Dunchon-daero, Jungwon-gu, |
| Seongnam-si, Gyeonggi-do,13230, KOREA | |
| Telephone No.: | +82-31-740-4100 |
| Fax: | +82-31-737-8018 |
| Official Correspondent (U.S): Kaitlynn Min - Business Manager |
| Correspondent: | GENORAY America Inc. |
|---|---|
| Address: | 147 E. Bristol Lane, Orange, CA 92865 USA |
| Telephone No.: | +1-855-436-6729 |
| Fax: | +1-714-786-8919 |
| Email: | kaitlynn @ genorayamerica.com |
2. Establishment Registration Number 3005843418
3. Device Information
| Trade/Device Name: | PORT-X IV |
|---|---|
| Regulation Name: | Portable X-ray System |
| Classification Name: | Extraoral Source X-ray System |
| Product Code: | EHD |
| Device Class: | Class II per regulation 21 CFR 872.1800 |
-
- Predicate Device(Equivalent Legally Marketed Device)
| Manufacturer: | Metabiomed, Inc. |
|---|---|
| Device Name: | REXTAR X |
| 510(k) Number: | K132041 (Decision Date – Jul 31, 2013) |
| Classification: | Extraoral Source X-ray System |
| Class II per regulation 21 CFR 872.1800 |
-
- Description of the Device
The portable X-Ray system, PORT-X IV, 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. It is the X-ray equipment and uses it to diagnose the patient to
- Description of the Device
4
acquire images. It also includes accessories, which are battery, recharging unit and hand switch.
6. Indications for use (intended use)
PORT-X IV is a Portable X-Ray System to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.
| Proposed device | Predicate device | |
|---|---|---|
| Name | PORT-X IV | REXTAR X |
| Manufacturer | GENORAY Co., Ltd. | Metabiomed, Inc. |
| 510(k) No. | - | K132041 |
| Indications | ||
| for use | PORT-X IV is a portable X-ray | |
| system to be used by trained dentists | ||
| and dental technicians as a mobile, | ||
| extraoral x-ray source for producing | ||
| diagnostic x-ray images using | ||
| intraoral image receptors. It is | ||
| intended for both adult and pediatric | ||
| subjects. | REXTAR X is a portable X-ray | |
| system to be used by trained dentists | ||
| and dental technicians as a mobile, | ||
| extraoral x-ray source for producing | ||
| diagnostic x-ray Images using | ||
| Intraoral Image receptors. It is | ||
| intended for both adult and pediatric | ||
| subjects. | ||
| X-ray | ||
| Generator | Tube Voltage : 70 kV | |
| Tube Current : 2 mA | Tube Voltage : 70 kV | |
| Tube Current : 2 mA | ||
| X-ray Controller | Exposure Time : 0.05~1.6 sec | Exposure Time : 0.01~1.30 sec |
| X-ray Tube | Stationary Anode | Stationary Anode |
| Focus : 0.4 mm | Focus : 0.4 mm | |
| Target Angle : 12.5° | ||
| Total Filtration : 2.2 mmAl | ||
| (Inherent Filtration : 1.0 mmAl; | ||
| Additional Filtration : 1.2 mmAl) | Target Angle : 12° | |
| Total Filtration : 1.5 mmAl | ||
| (Inherent Filtration : 1.0 mmAl; | ||
| Additional Filtration : 0.5 mmAl) | ||
| Battery | Type : Rechargeable | Type : Rechargeable |
| Display | LCD panel Display | LCD panel Display |
| Dimensions and | ||
| Weight | Dimension(mm):140 x 173 x 254 | |
| Weight(kg): 1.6 kg | Dimension(mm): 146 x 155 x 139 | |
| Weight(kg): 2 kg |
-
- Substantial equivalence chart
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The technical characteristics of the PORT-X IV and predicate device are similar. However the range of the exposure time and the total filtration of X-rav tube are little different. Those differences does not affect the performance and safety. EMC and performance data demonstrated that the PORT-X IV is as safe and effective as the predicate device.
The PORT-X IV is substantially equivalent to the predicate device, REXTAR X(K132041).
8. Safety, EMC and Performance data comparison to Predicate device
- Safety, EMC and Performance Data
PORT-X IV complies with industry standards such as IEC 60601-1 Series and 21 CFR 1020.30 and 21CFR 1020.31 to minimize electrical, mechanical and radiation hazards.
- · Electrical, mechanical, environmental safety and performance testing which are mentioned in the standard IEC 60601-1, IEC 60601-1-3 and IEC 60601-2-65 were performed.
- · EMC testing was conducted in accordance with standard IEC 60601-1-2.
- · Performance testing performed according to FDA 21 CFR 1020.30, 21 CFR 1020.31 standards, Software Validation, Clinical Evaluation. All test results were satisfactory.
- Summary of Performance Testing
The performance test for the subject device, PORT-X IV and the predicate device, REXTAR X(K132041) confirmed that the focal spot to skin distance of both devices were longer than the minimum length of 18 cm in accordance with Federal Standard (21CFR 1020.30 and 31) requirements. Also minimum HVL (half-value layer) of both devices were 1.5 mm in accordance with Federal Standard (21CFR 1020.30 and 31) requirements. Accuracy of loading factors and reproducibility of AIR KERMA for both devcies also met the essential performance requirements in accordance with IEC 60601-1 (ex.