(24 days)
No
The summary describes a standard digital X-ray detector and does not mention any AI or ML capabilities, image processing algorithms, or training/test data sets related to AI/ML.
No
This device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for providing general radiographic diagnosis of human anatomy" and "intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures."
No
The device description clearly outlines hardware components (indirect conversion device, optical sensor, thin film transistors) that convert X-rays into electrical signals and then digital data. This is not a software-only 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 taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "Digital X-ray detector" used for "general radiographic diagnosis of human anatomy." It converts X-rays into digital images of the body.
- Intended Use: The intended use is for "digital imaging solution designed for providing general radiographic diagnosis of human anatomy," replacing film or screen-based radiographic systems. This involves imaging the body directly, not analyzing samples taken from the body.
The information provided describes a medical imaging device that uses X-rays to create images of the internal structures of the body. This falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643WG / EVS 3643WP Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP Digital X-ray detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light. This visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta. The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing. The detectors differ in terms of the layers of their scintillators and TFT Type: EVS 4343W and EVS 3643W use CsI scintillator and amorphous Silicon TFT; EVS 4343WG and EVS 3643WG use GOS scintillator and amorphous Silicon TFT; EVS 4343WP and EVS 3643WP use CsI scintillator and amorphous IGZO TFT. The device functions with compatible Econsolel software (Cleared under K152172).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy / General Radiography
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A single blind clinical image evaluation according to CDRH's "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was conducted. 8 positions of body parts (Chest PA, Cspine AP, C-spine LAT, L-spine LAT, Shoulder AP, Shoulder LAT, Extremities) were selected to compare image performance between EVS 4343WP, EVS 3643WP and EVS 3643(K162552). It is indicated that there is no significant difference of image performance between EVS 4343WP, EVS 3643WP and EVS 3643 as difference in the score is within one standard deviation. This clinical image evaluation confirmed that the subject x-ray detectors (EVS 4343WP, EVS 3643WP) provide images of equivalent diagnostic capability to the predicate device (EVS 3643 -K162552).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DQE:
EVS 4343W: 52.8% at 1.0 lp/mm
EVS 3643W: 53.3% at 1.0 lp/mm
EVS 4343WP: 50.0% at 1.0 lp/mm
EVS 3643WP: 53.1% at 1.0 lp/mm
EVS 4343WG: 25.1% at 1.0 lp/mm
EVS 3643WG: 25.9% at 1.0 lp/mm
MTF:
EVS 4343W: 50.0% at 2.0 lp/mm
EVS 3643W: 42.5% at 2.0 lp/mm
EVS 4343WP: 48.4% at 2.0 lp/mm
EVS 3643WP: 42.9% at 2.0 lp/mm
EVS 4343WG: 50.1% at 2.0 lp/mm
EVS 3643WG: 47.8% at 2.0 lp/mm
Resolution: 3.5 lp/mm
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.
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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January 26, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
DRTECH Corporation Shin Dongwook Regulatory Affairs Responsible Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29 Dunchon-daero541 beon-gil, Jungwon-gu, Seongam-si, 13216 REPUBLIC OF KOREA
Re: K193017
Trade/Device Name: EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643W / EVS 3643WG / EVS 3643WP Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB
Dear Shin Dongwook:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 22, 2019. Specifically, FDA is updating this SE Letter as an administrative correction to update the 510(k) Summary document, where the dimensions of several detector models were previously misstated as "13" instead of "14".
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Lu Jiang, OHT8: Office of Radiological Health, 240-402-5779, lu.jiang@fda.hhs.gov.
Sincerely,
Z. H. Ke
Laurel Burk, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/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.
November 22, 2019
DRTECH Corporation % Shin Dongwook Regulatory Affairs Responsible Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29 Dunchon-daero541 beon-gil, Jungwon-gu, Seongam-si, 13216 REPUBLIC OF KOREA
Re: K193017
Trade/Device Name: EVS 4343W / EVS 4343WG / EVS 3643WP / EVS 3643W / EVS 3643WG / EVS 3643WP Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: October 28, 2019 Received: October 29, 2019
Dear Shin Dongwook:
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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Hole 2. Nils
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K193017
Device Name
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
Indications for Use (Describe)
The EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643WG / EVS 3643WP Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
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
[As required by 21 CFR 807.92]
K193017
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
11/22/2019
2. Submitter's Information [21 CFR 807.92(a) (1)]
- Name of Sponsor: DRTECH Corporation ● Address: Suite No.1, 1 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, ● Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea ● Contact Name: DONGWOOK, SHIN
- Telephone No.: + 82-31-779-7783
- Fax No.: + 82-31-779-7790 ●
- Email Address : dwshin@drtech.co.kr
- . Registration Number: 3005172103
- Name of Manufacturer: Same as Sponsor ●
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)|
| • Trade Name: | EVS 4343W / EVS 4343WG / EVS 4343W
EVS 3643W / EVS 3643WG / EVS 3643W |
|-------------------------|--------------------------------------------------------------------------|
| • Common Name: | Digital Flat Panel X-ray Detector |
| • Classification Name: | Stationary X-ray System |
| • Classification Panel: | Radiology |
- Radiology . Classification Regulation: 21 CFR 892.1680
- Product Code: MQB
- Device Class: II ●
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
- 510(k) Number: K162552 ●
- Applicant: DRTECH Corporation ●
- Trade Name: EVS 3643 / EVS 3643G
- Classification Name: Stationary X-ray System ●
- Classification Panel: Radiology ●
- Classification Regulation: 21 CFR 892.1680 ●
- Product Code: MQB ●
- Device Class: II ●
006 1/8 510(k) Summary
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5. Description of the Modified Device [21 CFR 807.92(a) (4)]
Addition of EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643 WP: The differences between the subject devices and the predicate devices are the size and the performance (MTF, DQE) of their detectors. In case of EVS 3643WP and EVS 4343WP, the TFT type was changed from amorphous Silicon to amorphous IGZO. These detectors differ in terms of the layers of their scintillators and TFT Type as shown in the following table:
| Model Name | Scintillator layer | Photodiode | TFT |
|---|---|---|---|
| EVS 4343W | CsI (Cesium Iodide) | a-Si(PIN diode) | amorphous Silicon |
| EVS 4343WG | GOS (Gadolinium Oxysulfide) | a-Si(PIN diode) | amorphous Silicon |
| EVS 3643W | CsI (Cesium Iodide) | a-Si(PIN diode) | amorphous Silicon |
| EVS 3643WG | GOS (Gadolinium Oxysulfide) | a-Si(PIN diode) | amorphous Silicon |
| EVS 4343WP | CsI (Cesium Iodide) | a-Si(PIN diode) | amorphous IGZO |
| EVS 3643WP | CsI (Cesium Iodide) | a-Si(PIN diode) | amorphous IGZO |
IGZO is compound of indium(In)-gallium(Ga)-zinc(Zn)oxygen(O) and this compound is utilized as semiconductor material of TFT. Semiconductor material is only different material between conventional amorphous silicon TFT, that utilizing silicon as semiconductor material, and amorphous IGZO TFT. As IGZO has less resistance and leakage current on TFT switch off status than conventional amorphous silicon TFT, resistance capacity delay time for signal output could be reduced compare to conventional amorphous silicon TFT and also, line noise could be reduced compare to conventional amorphous silicon TFT. Difference between amorphous IGZO and conventional amorphous silicon TFT is shown in below table and right figure.
Image /page/5/Figure/7 description: The image shows a graph of transfer characteristics, with the x-axis representing gate voltage in volts and the y-axis representing log drain current in amperes. Two curves are plotted on the graph, one for IGZO and one for a-Si. The IGZO curve is solid and the a-Si curve is dashed. The graph also includes annotations indicating 'Low Ron' and 'Low leakage current'.
| Category | IGZO TFT | a-Si TFT |
|---|---|---|
| Active Layer | ||
| (Semiconductor | ||
| Material) | indium(In)-gallium(Ga)-zinc(Zn)- | |
| oxygen(O) | Silicon(Si):H | |
| Crystal structure | Amorphous | Amorphous |
| On Resistance(Ron) | 0.1~0.9MΩ | 1~10MΩ |
| Leakage current | ||
| (TFT switch off status) |