(253 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the hardware components and basic X-ray generation principles. There is no mention of any software or algorithms that would suggest AI/ML capabilities.
No.
The device is used for diagnosis (producing diagnostic x-ray intraoral image receptors), not for therapy.
Yes
The intended use explicitly states the device is for "producing diagnostic x-ray intraoral image receptors." Although the device itself doesn't perform the diagnosis, it generates the images used for diagnosis, making it a diagnostic device within the broader context of medical imaging.
No
The device description explicitly lists multiple hardware components including an X-ray tube head, high voltage generator, control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting cone, remote control switch, and an integrated INTEL stick PC. This indicates it is a hardware device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device function: The EZER Portable X-Ray system is an imaging device. It generates X-rays that pass through the body to create images, which are then interpreted by a trained professional. It does not analyze biological specimens.
The information provided clearly describes a medical imaging device used for diagnostic purposes, but it operates on the principle of generating and detecting radiation, not analyzing biological samples.
N/A
Intended Use / Indications for Use
EZER Portable X-Ray system is intended to be used by trained dental technicians as an extraoral x-ray source for producing diagnostic x-ray 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, MUH
Device Description
EZER Portable X-ray System generates and controls X-ray in order to diagnose of tooth and iaw. It operates on 22.2VDC supplied by a rechargeable Lithum-Ion Polymer battery pack. The X-ray tube head, X-ray controls and power source are assembled into a single hand-held enclosure. EZER Portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting cone, and a remote control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates tooth and makes x-ray images on receptor. INTEL stick PC is integrated with EZER so the user can see X-ray image from LCD display without a computer. EZER Portable X-ray System is intended to be used by trained dentists or dental technicians.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Tooth and jaw
Indicated Patient Age Range
both adult and pediatric subjects
Intended User / Care Setting
trained dental technicians, 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)
Non clinical testing was performed successfully according to IEC, EN, and CFR standards. The device also conforms to 21 CFR 1020 Subchapter J, 21 CFR 1020.30, and 21 CFR 1020.31. Performance evaluation (test) reports and device inspection report confirmed that the EZER Portable X-ray System suitable for its intended use and user instruction of the device.
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.
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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 & 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.
December 19, 2019
LIVERMORETECH, Inc. % Mr. Dave Kim Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K190935
Trade/Device Name: EZER, Portable X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: November 20, 2019 Received: November 20, 2019
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 (reporting of medical device-related adverse events) (21 CFR 803) for devices
1
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.
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) K190935
Device Name EZER Portable X-ray System
Indications for Use (Describe)
EZER Portable X-Ray system is intended to be used by trained dental technicians as an extraoral x-ray source for producing diagnostic x-ray intraoral image receptors. Its use is intended for both adult and pediatric 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) |
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510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: Nov 15, 2019
SUBMITTER I.
| Submitter's Name
Submitter's Address | Livermoretech
801 North Jupiter Rd, Suite 200
Plano TX 75074 |
|-----------------------------------------|--------------------------------------------------------------------|
| Submitter's Telephone | Jay Kim (jay.kim@aspenstate.com) / RA Manage |
| Contact person | Tel: +1-214-257-0113 |
| Official Correspondent | Dave Kim (davekim@mtech-inc.net) |
| Address | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone | +713-467-2607 |
| Fax: | +713-583-8988 |
II. DEVICE
| Trade/proprietary Name | Portable X-ray System |
|---|---|
| Model Name: | EZER |
| Common or Usual Name | Portable X-ray System |
| Regulation Name | Extra-oral Source X-Ray System |
| Regulation Number | 21 CFR 872.1800 |
| Product Code | MUH |
| Regulatory Class | Class II |
III. PREDICATE DEVICE
| 510K Number | K134055 |
|---|---|
| Manufacturer | Dexcowin Co., Ltd |
| Device Name | ADX 4000W; iRay D4 |
| Regulation Name | Extra-oral Source X-Ray System |
| Regulation Number | 21 CFR 872.1800 |
| Product Code | EHD |
| Regulatory Class | Class II |
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DEVICE DESCRIPTION: IV.
EZER Portable X-ray System generates and controls X-ray in order to diagnose of tooth and iaw. It operates on 22.2VDC supplied by a rechargeable Lithum-Ion Polymer battery pack. The X-ray tube head, X-ray controls and power source are assembled into a single hand-held enclosure. EZER Portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting cone, and a remote control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates tooth and makes x-ray images on receptor. INTEL stick PC is integrated with EZER so the user can see X-ray image from LCD display without a computer. EZER Portable X-ray System is intended to be used by trained dentists or dental technicians. Its use is intended for both adult and pediatric subjects.
The embedded 7' TFT display in EZER Portable X-ray is not intended to be used for diagnosis.
V. Indications for Use: 21 CFR 807 92 (a) (5)
EZER 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.
| DEXCOWIN | LIVERMORETECH | |
|---|---|---|
| FEATURE | ADX 4000W | EZER |
| (K134055) | (NEW) | |
| The ADX4000W Cordless Portable Dental X- | ||
| Ray System is indicated for use only by | ||
| trained and qualified dentists or dental | ||
| technicians for both adult and pediatric | ||
| subjects for taking diagnostic extraoral | ||
| dental X-ray digital sensors. | EZER 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 | ||
| Size | 240(L) x 166(W) x 82(H) [mm] | |
| (9.4" x 6.5" x 3.2") | 233.5(L) x 162.9(W) x 116.9(H) [mm] | |
| 9.2" x 6.4" x 4.6" | ||
| Weight | 2.4 kg | 2.6 kg |
| Total filtering | Over 1.5mmAl (inherent filtration : 0.8mmAl) | Over 1.5mmAl (inherent filtration : 0.8mmAl) |
| Cone diameter | 7 cm | 6 cm |
| User interface | Up-down buttons for exposure time selection | |
| with timer display. Additionally, several user- | ||
| selectable preset times with patient size and | ||
| tooth selection icons on an LCD display | Up-down buttons for exposure time selection | |
| with timer display. | ||
| Backscatter | ||
| radiation | ||
| protection | 6.3" dia. Pb-filled acrylic | |
| plastic scatter shield | 6.3" dia. Pb-filled acrylic | |
| plastic scatter shield |
Technological characteristics: 21 CFR 807 92 (a) (6) Comparison Table
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LIVERMORETECH
801 North JupiterRd, Suite 200, Plano, TX 70574 USA
Tel.: +214-257-0113
| Exposure switch | Exposure button at x-ray control panel | Exposure button at back cover on right hand
side,
or a remote control switch |
|--------------------|--------------------------------------------------------|------------------------------------------------------------------------------------|
| Tube head mounting | Handheld, or on a tripod | Handheld, or on a tripod |
| CPU | 1.6 Ghz | Intel Atom x5 Z8300 Processor (1.84 Ghz) |
| Display | 4.8 inch Touch Panel TFT-LCD (1024x600) | 7 inch TFT LCD Panel
(Resolution : 1024 x 600) |
| Energy source | Rechargeable 22.2 V DC
Lithium Polymer battery pack | Rechargeable 22.2 V DC
Lithium Ion Polymer battery pack |
| Exposure time | 0.05 ~ 1.35 seconds in 0.01 increments | 0.03~1.30 seconds in 0.01
increments |
| Time Accuracy | $\pm$ (10% +1 ms) | $\pm$ (10% ) |
| mA | 2 mA fixed | 2 mA fixed |
| kVp | 65 kV fixed | 60 kV fixed |
| Waveform | Constant Potential (DC) | Constant Potential (DC) |
VI. Discussion of differences
The subject device is identical to the predicate device in terms of the indications for use and type of energy source. Both devices have on board computer and a display screen that allows the doctor to view dental X-ray images. The differences are device design, size and user interface.
VII. Non clinical testing
Testing was performed successfully according to the following standards:
-
IEC 60601-1-3:2008+A1:2013
-
IEC 60601-2-65:2012
-
EN 60601-2-65:2013
-
EN 60601-1-2:2015
-
IEC 62133:2012
-
EN 62133:2013
-
EN 60601-1:2006/A1:2013
-
IEC 60601-2-54:2009 (First edition) + A1:2014 for use in conjunction with IEC 60601-1:2015 (third edition) + A1:2012
-
IEC 61000-4-3: 2006 + A2: 2010
Test for proximity fields from RF wireless communications equipment
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: "Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use"
6
"The Content of Premarket Submissions for Software Contained in Medical Devices" "Content of Premarket Submission for Management of Cybersecurity in Medical Devices" "Radio Frequency Wireless Technology in Medical Device Guidance for Industry and FDA Staff"
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
VIII. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided above comparison table, the EZER Portable X-ray System has little difference with its size and user interface as the information in the table. But the system is substantially equivalent to the predicate devices with its design, mechanical and electrical performance as described.
Performance evaluation (test) reports and device inspection report confirmed that the EZER Portable X-ray System suitable for its intended use and user instruction of the device.