(48 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the device description focuses on the hardware components and basic X-ray functionality.
No
The device is described as an X-ray system intended for diagnostic purposes (assisting the diagnosis of bones and tissues), not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "limited to taking diagnostic X-rays of extremities." Additionally, the "Device Description" section notes that the device "is intended to assist the diagnosis of bones and tissues through X-ray exposure."
No
The device description explicitly states it is a "portable general-purpose X-ray system" and lists hardware components such as an "X-ray generating part with an X-ray tube," "device controller," "power controller," "user interface," and "beam limiting part." This indicates it is a hardware device with integrated software, not a software-only medical 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the EzRay M is a portable general-purpose X-ray system used to take diagnostic X-rays of extremities. It generates X-rays that pass through the body to create an image on an imaging receptor.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. Its function is based on generating and capturing radiation that interacts with the patient's body.
Therefore, based on the provided information, the EzRay M is a radiological diagnostic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EzRay M (Model: VMX-P300) is a portable general-purpose X-ray system that users can operate with one hand. The device uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on adult patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp), which may be required for full optimization of image quality and radiation exposure for different exam types.
Product codes
IZL
Device Description
EzRay M (Model: VMX-P300), a medical portable X-ray system, operates on 21.6 Vdc supplied by a rechargeable Li-ion battery pack. The system is designed for medical examination and composed of an X-ray generating part with an X-ray tube including a device controller, a power controller, a user interface, a beam limiting part, and optional items. It is intended to be used by a qualified and trained clinician on adult patients. The device is intended to assist the diagnosis of bones and tissues through X-ray exposure using an imaging receptor. The image receptor (an integral part of a complete diagnostic system) is not part of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
extremities
Indicated Patient Age Range
adult patients
Intended User / Care Setting
qualified and trained clinician
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)
Non clinical Testing was performed successfully according to the following standards:
- IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012
- IEC 60601-1-2:2014
- IEC 60601-1-3:2008 (Second Edition) + A1:2013
- IEC 60601-2-28:2017
- IEC 60601-2-54:2009, AMD1:2015, AMD2:2018
- IEC 62133:2012
Furthermore, the following Specific Guidance Document was utilized in the device development to ensure the safety of this device for both the operators and patients:
"The Content of Premarket Submissions for Software Contained in Medical Devices" "Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use"
The device also conforms to the following:
21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products
- 21 CFR 1020.30: Diagnostic x-ray system and their major components
- 21 CFR 1020.31: Radiographic Equipment
Key results: As demonstrated in the performance bench testing, X-ray performance and X-ray Safety of the subject device was tested in accordance with Federal standard 21CFR Part 1020.30 and 31 as well as international standards such as IEC 60601-2-54. Quality assurance procedures are adhered to, and the specifications and functional requirements were met as the test results indicated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 2, 2021
Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 7707 Fannin Street, Suite 200-V111 HOUSTON TX 77054
Re: K203667
Trade/Device Name: EzRay M (Model: VMX-P300) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: December 10, 2020 Received: December 16, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203667
Device Name EzRay M (Model: VMX-P300)
Indications for Use (Describe)
EzRay M (Model: VMX-P300) is a portable general-purpose X-ray system that users can operate with one hand. The device uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on adult patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp), which may be required for full optimization of image quality and radiation exposure for different exam types.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5 – 510(k) Summary K203667
1. Traditional 510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
2. Date 510K Summary prepared: January15, 2021
3. Administrative Information
| Official Correspondent: | Dave Kim / Mtech Group
Address: 7707 Fannin St., Ste. 200-V111, Houston, TX 77054
Tel: +713-467-2607
Contact person: Mr. Dave Kim (davekim@mtech-inc.net) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | VATECH Co., Ltd.
Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea
Tel: +82-31-379-9492
Fax: +82-31-379-9400
Contact person: Daniel Kim / Manager (daniel.kim@vatech.com) |
4. Device Information
| Type of 510(k) Submission: | Traditional |
|---|---|
| Trade or Proprietary Name: | EzRay M (Model: VMX-P300) |
| Common or Usual Name: | Medical Portable X-ray System |
| Regulation Classification: | Mobile X-ray system (21 CFR 892.1720) |
| Product Code: | IZL |
| Class of Device: | Class II |
| Panel: | Radiology |
5. Predicate Device Information
| Manufacturer: | Aribex, Inc. |
|---|---|
| Trade or Proprietary Name: | NOMAD MD Handheld X-ray System |
| Common or Usual Name: | Nomad MD |
| Regulation Classification: | Mobile X-ray system (21 CFR 892.1720) |
| Product Code: | IZL |
| Class of Device: | Class II |
| Panel: | Radiology |
| 510(k) Number: | K140723 |
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6. Device Description
EzRay M (Model: VMX-P300), a medical portable X-ray system, operates on 21.6 Vdc supplied by a rechargeable Li-ion battery pack. The system is designed for medical examination and composed of an X-ray generating part with an X-ray tube including a device controller, a power controller, a user interface, a beam limiting part, and optional items. It is intended to be used by a qualified and trained clinician on adult patients. The device is intended to assist the diagnosis of bones and tissues through X-ray exposure using an imaging receptor. The image receptor (an integral part of a complete diagnostic system) is not part of this submission.
7. Indication for use
EzRay M (Model: VMX-P300) is a portable general-purpose X-ray system that users can operate with one hand. The device uses a fixed tube current and voltage (KVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on adult patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp), which may be required for full optimization of image quality and radiation exposure for different exam types.
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8. Substantial Equivalence Chart
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Device Name | EzRay M (Model: VMX-P300) | NOMAD MD Handheld X-ray System | |
| Applicant Name | VATECH Co., Ltd. | Aribex, Inc. | |
| 510(k) Number | K203667 | K140723 | |
| Device Classification Name | Mobile x-ray system | Mobile x-ray system | |
| Classification Product Code | IZL | IZL | |
| Regulation Number | 21 CFR 892.1720 | 21 CFR 892.1720 | |
| Regulation Class | II | II | |
| Indications for Use | EzRay M (Model: VMX-P300) is a | ||
| portable general-purpose X-ray system | |||
| that users can operate with one hand. | |||
| The device uses a fixed tube current | |||
| and voltage (kVp) and, therefore, is | |||
| limited to taking diagnostic X-rays of | |||
| extremities. It is intended to be used | |||
| by a qualified and trained clinician on | |||
| adult patients. It is not intended to | |||
| replace a radiographic system with | |||
| variable tube current and voltage | |||
| (kVp), which may be required for full | |||
| optimization of image quality and | |||
| radiation exposure for different exam | |||
| types. | The NOMAD MD is a handheld and | ||
| portable general purpose X-ray system. | |||
| The device uses a fixed tube current and | |||
| voltage (kVp) | |||
| and, therefore, is limited to taking | |||
| diagnostic X-rays of extremities. It is | |||
| intended to be used by a qualified and | |||
| trained clinician on both adult and | |||
| pediatric patients. It is not intended to | |||
| replace a radiographic system with | |||
| variable tube current and voltage (kVp) | |||
| which may be required for full | |||
| optimization of image quality and | |||
| radiation exposure for different exam | |||
| types. | |||
| Principle of Operation | General Purpose Diagnostic X Ray | General Purpose Diagnostic X Ray | |
| Size: Body | 11.0" L x 5.4" W x 11.1" H | ||
| (excluding Skin Distance Bar) | 9.5" H x 5.25" W x 10" L | ||
| (excluding Source Skin guard) | |||
| Weight | 4.14 lbs | 11.0 lbs. | |
| Source to skin distance | 30 cm with Skin Distance Bar | 30 cm | |
| Focal Spot | 0.5 mm | ||
| Technol | |||
| ogical | Collimator | Four manually and steplessly | |
| adjustable shutters with x-ray field | |||
| indicator | Four manually and steplessly adjustable | ||
| shutters with LED Light Field Center | |||
| Indicator | |||
| User Interface | Jog dial for operating mode selection. | ||
| Additionally, several user-selectable | |||
| preset times with exposure time | |||
| selection icons on a display module. | Up-down buttons for exposure time | ||
| selection, with timer display. | |||
| Energy source | Rechargeable 21.6 V DC | ||
| Li-ion polymer battery pack | Rechargeable 14.4 V DC | ||
| NiCd battery pack | |||
| Exposure time | 0.05 - 1.0 seconds | ||
| in 0.01 increments | 0.02 - 0.99 seconds | ||
| in 0.01 increments | |||
| mA | 3.0 mA fixed | ||
| kVp | 65 kVp fixed | 75 kVp fixed |
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9. The differences between the subject device and the predicate device
The subject device described in this traditional 510(k) is similar to the predicate device (K140723) in its indications for use and technological application. Both the subject and predicate devices are taking diagnostic Xrays of extremities using a fixed tube current and voltage (kVp). The exposure parameters of the EzRay M device (KVp, mA, s) are similar to the predicate Nomad MD. For the energy source, battery pack, the subject device receives power from the built-in rechargeable Li-ion polymer battery pack whereas the predicate device (K140723) uses Rechargeable NiCd battery pack. Rechargeable Li-ion polymer battery pack has been tested and is in conformity with the standard IEC 62133. Other differences include device design such as exposure time, size and user interface.
10. Non clinical Testing
Testing was performed successfully according to the following standards:
- IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 ●
- IEC 60601-1-2:2014 ●
- IEC 60601-1-3:2008 (Second Edition) + A1:2013
- IEC 60601-2-28:2017
- IEC 60601-2-54:2009, AMD1:2015, AMD2:2018
- IEC 62133:2012
Furthermore, the following Specific Guidance Document was utilized in the device development to ensure the safety of this device for both the operators and patients:
"The Content of Premarket Submissions for Software Contained in Medical Devices" "Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use"
The device also conforms to the following:
21 CFR 1020 Subchapter J: Performance Standards for lonizing Radiation Emitting Products
- 21 CFR 1020.30: Diagnostic x-ray system and their major components
21 CFR 1020.31: Radiographic Equipment
11. Conclusions
In reference to the comparison provide in Substantial Equivalence Chart, the subject device and the predicate device have little difference with its technological features. As demonstrated in the performance bench testing, X-ray performance and X-ray Safety of the subject device was tested in accordance with Federal standard 21CFR Part 1020.30 and 31 as well as international standards such as IEC 60601-2-54. Quality assurance procedures are adhered to, and the specifications and functional requirements were met as the test results indicated.
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 EzRay M (Model: VMX-P300) is substantially equivalent to predicate device as described herein.