(30 days)
No
The description focuses on the hardware and basic signal processing of a digital X-ray detector, with no mention of AI, ML, or advanced image analysis beyond basic conversion and transmission.
No
The device is an X-ray detector used for diagnostic imaging, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the device is "indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This explicitly indicates its use in diagnosis.
No
The device description explicitly details a "flat-panel type digital X-ray detector" which is a physical hardware component that captures X-ray images. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This describes a device used for imaging the human body, not for examining specimens taken from the body (like blood, urine, or tissue).
- Device Description: The description details how the device captures X-ray images of the body. It doesn't mention any processes involving biological samples or chemical analysis.
- Input Imaging Modality: The input modality is X-ray, which is used for imaging the body directly. IVDs typically involve analyzing samples.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is an imaging system used to visualize the internal structures of the body.
N/A
Intended Use / Indications for Use
The EVS 4343A / EVS 4343AG / EVS 3643AG 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 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-rav film or an image plate as an image capture medium. EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.
The EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG 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 through 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
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)
The non-clinical performance testing demonstrates that the main physical values for comparison of X-ray devices like DQE and MTF are basically equal or worth than the predicate device.
DQE for subject devices: EVS 4343A: 52.9% at 1.0 lp/mm, EVS 3643A: 50.5 % at 1.0 lp/mm, EVS 4343AG: 27.2 % at 1.0 lp/mm, EVS 3643AG: 26.3 % at 1.0 lp/mm.
MTF for subject devices: EVS 4343A: 44.1 % at 2.0 lp/mm, EVS 3643A: 44.5 % at 2.0 lp/mm, EVS 4343AG: 49.2 % at 2.0 lp/mm, EVS 3643AG: 46.3 % at 2.0 lp/mm.
The results demonstrate that the EVS 4343AG / EVS 3643A / EVS 3643AG meets the acceptance criteria and is adequate for its intended use, performing as well or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DQE
MTF
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.
0
January 26, 2023
Image /page/0/Picture/1 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 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.
DRTECH Corporation Choul-Woo Shin Vice President Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero541 beon-gil, Jungwon-gu, Seongam-si, Gyeonggi-do 13216 REPUBLIC OF KOREA
Re: K192400
Trade/Device Name: EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB
Dear Choul-Woo Shin:
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 October 3, 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,
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
1
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.
October 3, 2019
DRTECH Corporation % Choul-Woo Shin Vice President Suite No.1. 1 Floor / Suite No.2. 3 Floor, 29. Dunchon-daero541 beon-gil, Jungwon-gu, Seongam-si, Gyeonggi-do 13216 REPUBLIC OF KOREA
Re: K192400
Trade/Device Name: EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: August 27, 2019 Received: September 3, 2019
Dear Choul-Woo Shin:
We have reviewed vour 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
2
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 medical devices and radiation-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(@;tda.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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K192400
Device Name EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG
Indications for Use (Describe)
The EVS 4343A / EVS 4343AG / EVS 3643AG 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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4
DRTECH Corporation Suite No.1, 1 Floor / Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
510(k) Summary
[As required by 21 CFR 807.92]
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)]
08/27/2019
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: ● Choul-Woo 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 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG
- Common Name: Digital Flat Panel X-ray Detector ●
- Classification Name: Stationary X-ray System ●
- Classification Panel: Radiology
- Classification Regulation: 21 CFR 892.1680
- Product Code: MOB ●
- Device Class: ● II
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
- 510(k) Number: K162555 ●
- . Applicant: DRTECH Corporation
- Trade Name: EVS 4343 / EVS 4343G ●
- Classification Name: Stationary X-ray System ●
- Classification Panel: Radiology
- Classification Regulation: 21 CFR 892.1680
- Product Code: MQB ●
- Device Class: ● II
006 1/7 510(k) Summary
5
DRTECH Corporation Suite No.1, 1 Floor / Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
5. Description of the Modified Device [21 CFR 807.92(a) (4)]
- Addition of EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG: The differences . between the subject devices and the predicate devices are adaptor, cable type and performance (MTF & DQE). Predicate devices used tether cable, Lan cable and SSU, however, subject devices use 2 Lan cables and PoE Adaptor. In case of EVS 3643A and EVS 3643AG, the size is smaller than EVS 4343 and EVS 4343G.
- . Optional components were removed such as interface cable, generator interface cable, USB switch box and hand switch compared to predicated devices components.
The EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-rav film or an image plate as an image capture medium. EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.
6. Intended Use [21 CFR 807.92(a)(5)]
The intended use has not been changed as a result of the modification and is as follows:
The EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG 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.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG 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 through 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.
Comparisons with the predicate, devices show the technological characteristics of the EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG to be same to the predicate devices. EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG is functionally identical to the predicate devices.
6
Contents
| Requirements | ||
|---|---|---|
| 80kHz ~ 240kHz | ||
| 60kVp ~ 150kVp |
| Power frequency | 30kHz ~ 240kHz | ||
|---|---|---|---|
| Generator | KV | 40kVp ~ 150kVp | |
| mA Range | 10mA ~ 1000mA | ||
| Exposure Time | 0.001~10sec | ||
| mAs Range | 0.1~1000mAs | ||
| Accuracy | ± 5% | ||
| Operating Type | moving | Stepping Motor | |
| Bucky | Spring | ||
| CAM Motor type | |||
| Static(Fixed) | |||
| Tray size | |||
| (mm) | 460 mm x 483 mm x 15.5 mm or higher | ||
| Ratio | 5:1, 6:1, 8:1, 10:1, 12:1, 15:1 | ||
| Grid | Line | 85 ~ 215 Line | |
| SID | 100 ~ 180 cm |
8. Hardware and Software Requirements
- X-ray System Requirement
- The EVS 4343A / EVS 4343AG / EVS 3643AG detector is not compatible with trays that are less than 460 mm x 483 mm x 15.5 mm.
- Software Requirement
The EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG detector is compatible with Econsole1 (K152172).
7
9. Substantial Equivalence [21 CFR 807.92(b)]
| Parameter | Subject Device | Predicate Device | |||||
|---|---|---|---|---|---|---|---|
| 510(K) Number | Unknown | K162555 | |||||
| Manufacturer | DRTECH Corporation | DRTECH Corporation | |||||
| Model Name | EVS 4343A / EVS 4343AG | ||||||
| EVS 3643A / EVS 3643AG | EVS 4343 / EVS 4343G | ||||||
| Classification Name | Stationary X-ray System | ||||||
| Classification Panel | Radiology | ||||||
| Classification | |||||||
| Regulation | 21 CFR 892.1680 | ||||||
| Product Code | MQB | ||||||
| Device Class | Class II | ||||||
| Intended Use | The EVS 4343A / EVS 4343AG / EVS | ||||||
| 3643A / EVS 3643AG 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 | The EVS 4343A / EVS 4343AG / EVS | ||||||
| 3643A / EVS 3643AG 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. | |||||||
| Panel Shape | EVS 4343A: Square Panel | ||||||
| EVS 4343AG: Square Panel | |||||||
| EVS 3643A: Rectangular Panel | |||||||
| EVS 3643AG: Rectangular Panel | Square Panel | ||||||
| Detector | |||||||
| Size | EVS 4343A: 17" X 17" | ||||||
| EVS 4343AG: 17" X 17" | |||||||
| EVS 3643A: 14" X 17" | |||||||
| EVS 3643AG: 14" X 17" | 17" X 17" | ||||||
| Design | |||||||
| Dimensions | EVS 4343A: | ||||||
| 460(W) x 483(L) x 15.5(H) | |||||||
| EVS 4343AG: | |||||||
| 460(W) x 483(L) x 15.5(H) | |||||||
| EVS 3643A: | |||||||
| 460(W) × 409(L) × 15.5(H) | |||||||
| EVS 3643AG: | |||||||
| 460(W) × 409(L) × 15.5(H) | 460(W) x 460(L) x 15(H) | ||||||
| Pixel Pitch | |||||||
| Image Size | EVS 4343A: 3,072 x 3,072 | ||||||
| EVS 4343AG: 3,072 x 3,072 | |||||||
| EVS 3643A: 2,560 x 3,072 | |||||||
| EVS 3643AG: 2,560 x 3,072 | 3,072 x 3,072 | ||||||
| Materials Scintillator | TFT –amorphous Silicon | ||||||
| EVS 4343A/EVS 3643A: CsI | |||||||
| EVS 4343AG/ EVS 3643AG: GOS | TFT –amorphous Silicon | ||||||
| EVS 4343: CsI | |||||||
| EVS 4343G: GOS | |||||||
| Performance | |||||||
| DQE | EVS 4343A: 52.9% at 1.0 lp/mm | ||||||
| EVS 3643A: 50.5 % at 1.0 lp/mm | |||||||
| EVS 4343AG: 27.2 % at 1.0 lp/mm | EVS 4343: 43.9 % at 1.0 lp/mm | ||||||
| EVS 4343G: 23.6 % at 1.0 lp/mm | |||||||
| MTF | EVS 3643AG: 26.3 % at 1.0 lp/mm | ||||||
| EVS 4343A: 44.1 % at 2.0 lp/mm | |||||||
| EVS 3643A: 44.5 % at 2.0 lp/mm | |||||||
| EVS 4343AG: 49.2 % at 2.0 lp/mm | |||||||
| EVS 3643AG: 46.3 % at 2.0 lp/mm | EVS 4343: 37.7 % at 2.0 lp/mm | ||||||
| EVS 4343G: 34.0 % at 2.0 lp/mm | |||||||
| Resolution | 3.5 lp/mm | 3.5 lp/mm | |||||
| Anatomical Sites | General Radiography | ||||||
| Power Supply | 100 | ||||||
| Component | PoE Adaptor | ||||||
| Lan cables (2 ea) | |||||||
| AC Power Cable | |||||||
| Ethernet Connector Bracket | |||||||
| Communication | |||||||
| Interface | Wired: Ethernet | Wired: Ethernet |
8
DRTECH Corporation Suite No.1, 1 Floor / Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
When compared to the predicate devices (K162555), the EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG presented in this submission have the same:
- Intended Use
- Technological characteristics •
- . Operating principle
- Performance (Resolution)
- Communication Method
A few differences are as follows
- Adaptor / cable type
- Components
- Size
- Performance (DQE and MTF)
There are no significant differences between the EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG and the predicate device(s) that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.
According to bench test report, it is proved that the DQE and MTF of predicated device and subject device are basically equal or worth than the predicate device. As a result, subject devices performance is equal or worth than the predicate device.
9
DRTECH
10. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
The non-clinical performance testing constrains that the main physical values for comparison of Xray devices like DQE and MTF are basically equal or worth than the predicate device as following table:
| Parameter | Modified Device | Predicate Device | Remark |
|---|---|---|---|
| DQE | EVS 4343A: 52.9% at 1.0 lp/mm | EVS 4343: 43.9 % at 1.0 lp/mm | |
| EVS 3643A: 50.5 % at 1.0 lp/mm | |||
| EVS 4343AG: 27.2 % at 1.0 lp/mm | EVS 4343G: 23.6 % at 1.0 lp/mm | ||
| EVS 3643AG: 26.3 % at 1.0 lp/mm | |||
| MTF | EVS 4343A: 44.1 % at 2.0 lp/mm | EVS 4343: 37.7 % at 2.0 lp/mm | |
| EVS 3643A: 44.5 % at 2.0 lp/mm | |||
| EVS 4343AG: 49.2 % at 2.0 lp/mm | EVS 4343G: 34.0 % at 2.0 lp/mm | ||
| EVS 3643AG: 46.3 % at 2.0 lp/mm |
The EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG detector complies with the following international and FDA-recognized consensus standards:
| Recognition No. | Standard No. | Title of Standard | Remark |
|---|---|---|---|
| 19-4 | ANSI AAMI ES60601- | ||
| 1:2005/(R)2012 and | |||
| A1:2012 | Medical electrical equipment |
- Part 1: General
requirements for basic safety
and essential performance
(IEC 60601-1:2005, MOD) | |
| 12-289 | IEC 62220-1 Edition 1.0
2015-03 | Medical electrical equipment-
Characteristics of digital X-
ray imaging devices Part 1-1:
Determination of the
detective quantum efficiency
Detectors used in
radiographic imaging | |
| 5-40 | ISO 14971 Second edition
2007-03-01 | Medical devices - Application
of risk management to
medical devices | |
| 5-89 | IEC 60601-1-6 Edition 3.1 | Medical electrical equipment - Part 1-6: General
requirements for basic safety
and essential performance -
Collateral standard: Usability | |
| 12-300 | PS 3.1 - 3.20 (2016) | Digital Imaging and
Communications in Medicine
(DICOM) Set | |
| 19-8 | IEC 60601-1-2 Edition 4.0 | Medical electrical equipment - Part 1-2: General
requirements for basic safety
and essential performance -
Collateral Standard:
Electromagnetic disturbances - Requirements and tests | |
| 13-32 | ANSI AAMI IEC
62304:2006 | Medical device software -
Software life cycle processes | |
10
11. Conclusion [21 CFR 807.92(b)(3)]
The modified EVS 4343A / EVS 4343AG / EVS 3643AG detector is substantially equivalent to the currently marketed and predicate device (EVS 4343(G), K162555) in terms of fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, Substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus standards, ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, ANSI AAMI IEC 62304:2006 and IEC 62220-1-1 which complied with the requirements specified in the CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
The results of these tests demonstrate that The EVS 4343AG / EVS 3643A / EVS 3643AG meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data and safety testing demonstrates that the device is as safe, as effective, and performs as well or better than the predicate devices.