(99 days)
Not Found
No
The summary describes a standard digital X-ray detector and its image capture process. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies. The performance study focuses on demonstrating equivalence to predicate devices based on image quality and diagnostic capability, not on the performance of an AI/ML algorithm.
No
The device is described as a digital X-ray detector intended for diagnostic imaging, which is used for diagnosis rather than therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy."
No
The device description explicitly states it is a "wired flat-panel type digital X-ray detector" and describes the physical components and processes involved in capturing X-ray images, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general radiographic diagnosis of human anatomy." This involves imaging the internal structures of the body using X-rays.
- Device Description: The description details how the device captures X-ray images electronically. This is consistent with medical imaging devices used for diagnosis in vivo (within the living body), not in vitro (outside the body, typically involving samples like blood or tissue).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the EVS 4343 and EVS 4343G Digital X-ray detector is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The EVS 4343 and EVS 4343G 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 radio graphic 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 4343(G) is a wired flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EVS 4343(G) 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 4343(G) 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 subject device integrates with X-ray system through three modes such as Auto Trigger mode (AT), Sync. Trigger mode and USB SW mode. The Auto Trigger Mode (AT) is available for acquiring images without any connection to X-ray generator interface cable is not required. The Sync. Trigger mode is the most common and recommended exposure mode at B2B scopes. User can achieve the high quality images with Sync. Tigger Mode. The USB SW Mode is the most common and recommended exposure mode at a retrofit scope. User can achieve high quality images with USB SW Mode.
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. The predicate device mentions "including both pediatric and adult patients" but this is not directly stated for the subject device.
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
A single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted.
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note X-ray detector technology that is identical to the predicate device) but they provide further evidence in addition to the laboratory performance data to show that the subject device works as intended.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data:
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.
DQE:
EVS 4343: 43.9 % at 1 lp/mm, 16.5% at 3 lp/mm
EVS 4343G: 23.6 % at 1 lp/mm, 5 % at 3 lp/mm
MTF:
EVS 4343: 35 % at 2.0 lp/mm
EVS 4343G: 34 % at 2.0 lp/mm
Clinical Data:
A single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted, and the study confirmed that the new x-ray detectors EVS 4343G provide images of equivalent diagnostic capability to the predicate devices (K142475 and K150766) and its results demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DQE: EVS 4343: 43.9 % at 1 lp/mm, 16.5% at 3 lp/mm; EVS 4343G: 23.6 % at 1 lp/mm, 5 % at 3 lp/mm
MTF: EVS 4343: 35 % at 2.0 lp/mm; EVS 4343G: 34 % 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.
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
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
DRTECH Corporation % Choul-Woo Shin Suite No. 2, 310 Floor, 29, Dunchon-daero541 beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13230 REPUBLIC OF KOREA
Re: K162555
Trade/Device Name: EVS 4343. EVS 4343G Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: December 2, 2016 Received: December 6, 2016
Dear Choul-Woo Shin:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Robert Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162555
Device Name EVS 4343, EVS 4343G
Indications for Use (Describe)
The EVS 4343 and EVS 4343G 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 radio graphic 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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)]
09/08/2016
2. Submitter's Information [21 CFR 807.92(a) (1)]
| • | Name of Sponsor: | DRTECH Corporation |
|---|---|---|
| • | Address: | Suit No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, |
| Jungwon-gu, Seongnam-si, Gyeonggi-do, 13230 | ||
| Republic of Korea | ||
| • | Contact Name: | Choul-Woo Shin |
| • | Telephone No.: | + 82-31-779-7783 |
| • | Fax No .: | + 82-31-779-7790 |
| • | Email Address : | cwshin@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 4343, EVS 4343G |
|---|---|---|
| • | 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: | MQB |
| • | Device Class: | II |
| • | 501(k) Number: | K162555 |
| • |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
| Parameter | Predicate Device |
|---|---|
| • 510(k) Number: | K142475 K150766 |
| • Applicant: | DRTECH Corporation Carestream Health, Inc. |
| • Trade Name: | Carestream DRX-1 System w/ DRX Plus Detectors EVS 4343 |
| • Classification Name: | Stationary X-ray System |
| • Classification Panel: | Radiology |
| • Classification Regulation: | 21 CFR 892.1680 |
| • Product Code: | MQB |
| • Device Class: | II |
4
5. Description of the Modified Device [21 CFR 807.92(a) (4)]
- The EVS 4343 was removed the function of wireless communication to transfer data.
- . Addition of EVS 4343G: This is to notify that EVS 4343 / EVS 4343G are same Hardware, Software and components. But scintillator layer are different. Scintillator is a phosphor that produces scintillations.
| Model Name | Scintillator layer |
|---|---|
| EVS 4343 | CsI (Cesium Iodide) |
| EVS 4343G | GoS (Gadolinium Oxysulfide) |
The EVS 4343(G) is a wired flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EVS 4343(G) 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 changed as a result of the modification and is as follows:
The EVS 4343 and EVS 4343G 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 4343(G) 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.
Comparisons with the predicate, devices show the technological characteristics of the EVS 4343(G) to be same to the predicate devices. The EVS 4343(G) is functionally identical to the predicate devices.
The subject device integrates with X-ray system through three modes such as Auto Trigger mode (AT), Sync. Trigger mode and USB SW mode. The Auto Trigger Mode (AT) is available for acquiring images without any connection to X-ray generator interface cable is not required. The Sync. Trigger mode is the most common and recommended exposure mode at B2B scopes. User can achieve the high quality images with Sync. Tigger Mode. The USB SW Mode is the most common and recommended exposure mode at a retrofit scope. User can achieve high quality images with USB SW Mode.
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Image /page/5/Picture/0 description: The image shows the word "DRTECH" in blue font. The letters are all capitalized and sans-serif. There is a small blue square above and to the left of the "D" in "DRTECH". A cursor is pointing at the "D".
8. Hardware and Software Requirements
- X-ray System Requirement
| Contents | Requirements | |
|---|---|---|
| Generator | Power frequency | 30kHz ~ 240kHz |
| KV | 40kVp ~ 150kVp | |
| mA Range | 10mA ~ 1000mA | |
| Exposure Time | 0.001~10sec | |
| mAs Range | 0.1~1000mAs | |
| Accuracy | $\pm$ 5% | |
| Bucky | Operating Type | moving |
| Stepping Motor | ||
| Spring | ||
| CAM Motor type | ||
| Static(Fixed) | ||
| Trey size (mm) | 460 x 460 x 15 or higher | |
| Grid | Ratio | 5:1, 6:1, 8:1, 10:1, 12:1, 15:1 |
| Line | 85 ~ 215 Line | |
| SID | 100 ~ 180 cm |
- The EVS 4343(G) detector is not compatible with trays that are less than 460 mm x 15 mm.
- Software Requirement
The EVS 4343(G) detector is compatible with Econsole1 (K152172).
9. Substantial Equivalence [21 CFR 807.92(b)]
| Parameter | Subject Device | Predicate Device | Remark | ||
|---|---|---|---|---|---|
| 510(K) Number | Unknown | K142475 | K150766 | - | |
| Manufacturer | DRTECH | ||||
| Corporation | DRTECH | ||||
| Corporation | Carestream | ||||
| Health, Inc. | - | ||||
| Model Name | EVS 4343, EVS | ||||
| 4343G | EVS 4343 | Carestream DRX-1 | |||
| System w/ DRX | |||||
| Plus Detectors | - | ||||
| Classification | |||||
| Name | Stationary X-ray System | same | |||
| Classification Panel | Radiology | same | |||
| Classification | |||||
| Regulation | 21 CFR 892.1680 | same | |||
| Product Code | MQB | same | |||
| Device Class | Class II | same | |||
| Intended Use | The EVS 4343 and | ||||
| EVS 4343G Digital | |||||
| X-ray detector is | |||||
| indicated | |||||
| for digital imaging | |||||
| solution designed for | |||||
| providing general | The EVS 4343 | ||||
| Digital X-ray | |||||
| detector is | |||||
| indicated | |||||
| for digital imaging | |||||
| solution designed | |||||
| for providing | The device is | ||||
| intended to | |||||
| capture for | |||||
| display | |||||
| radiographic | |||||
| images of human | same | ||||
| 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 | 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 | anatomy | ||||
| including both | |||||
| pediatric and | |||||
| adult patients. | |||||
| The device is | |||||
| intended for use | |||||
| in general | |||||
| projection | |||||
| radiographic | |||||
| applications | |||||
| wherever | |||||
| conventional | |||||
| screen-film | |||||
| systems or CR | |||||
| systems may be | |||||
| used. Excluded | |||||
| from the | |||||
| indications for | |||||
| use are | |||||
| mammography, | |||||
| fluoroscopy, and | |||||
| angiography | |||||
| applications. | |||||
| Design | Panel | ||||
| Shape | Square Panel | Square Panel | Rectangular Panel | same | |
| Detector | |||||
| Size | 17" X 17" | 17" X 17" | 13" X 17" | same | |
| Dimensions | 460(W) x 460(L) x | ||||
| 15(H) | 460(W) x 460(L) | ||||
| x 15(H) | - | same | |||
| Pixel | |||||
| Pitch | 140μm | 140μm | 139µm | same | |
| Image | |||||
| Size | 3,072 x 3,072 | 3,072 x 3,072 | - | same | |
| Materials | |||||
| Scintillator | TFT -amorphous | ||||
| Silicon | TFT -amorphous | ||||
| Silicon | TFT -amorphous | ||||
| Silicon | same | ||||
| EVS 4343: CsI | |||||
| EVS 4343G: GOS | EVS 4343: CsI | GOS | same | ||
| Performance | DQE | EVS 4343: | |||
| 43.9 % at 1 lp/mm | |||||
| 16.5 % at 3 lp/mm | |||||
| EVS 4343G: | |||||
| 23.6 % at 1 lp/mm | |||||
| 5 % at 3 lp/mm | 28 % at 1 lp/mm | ||||
| 13 % at 3 lp/mm | 29.7 % at 1 lp/mm | ||||
| 5.0 % at 3 lp/mm | similarity | ||||
| MTF | EVS 4343: 35 % at | ||||
| 2.0 lp/mm | 35 % at 2.0 lp/mm | 17.4% at 2 lp/mm | same | ||
| EVS 4343G: 34 % at | |||||
| 2.0 lp/mm | same | ||||
| Resolution | 3.5 lp/mm | 3.5 lp/mm | 3.5 lp/mm | same | |
| Anatomical Sites | General Radiography | General Radiography | General Radiography | same | |
| Power Supply | 100 | 100 | 100 | same | |
| Communication | |||||
| Interface | Wired: Ethernet | Wireless: | |||
| 2.4g/802.11g/n | |||||
| 5g/802.11a/n | |||||
| Wired: Ethernet | - | different |
6
IDRTECH
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Image /page/7/Picture/0 description: The image shows the logo for DR TECH. The logo is in blue and features a square above the letters 'DR'. The letters 'TECH' are in a slightly lighter shade of blue than the 'DR'. A mouse cursor is visible near the left side of the logo.
When compared to the predicate device (K142475 and K150766), the EVS 4343(G) presented in this submission has the same:
- Intended Use
- Technological characteristics
- Operating principle
- · Design features
- · Performance (DQE, MTF, Resolution)
- Materials Scintillator
A few differences are as follows
- Communication Method
There are no significant differences between the EVS 4343(G) 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.
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 | |
|---|---|---|---|---|
| K142475 | K150766 | |||
| DQE | EVS 4343: | |||
| 43.9 % at 1 | ||||
| lp/mm | ||||
| 16.5% at 3 lp/mm | 28 % at 1 lp/mm | |||
| 13 % at 3 lp/mm | 29.7 % at 1 lp/mm | |||
| 5.0 % at 3 lp/mm | same | |||
| similarity | ||||
| EVS 4343G: | ||||
| 23.6 % at 1 | ||||
| lp/mm | ||||
| 5 % at 3 lp/mm | ||||
| MTF | EVS 4343: 35 % at 2.0 lp/mm | 35 % at 2.0 lp/mm | 17.4% at 2.0 lp/mm | same |
8
| EVS 4343G:
34 % at 2.0
| lp/mm | same |
|---|---|
| ------------------------------------ | ------ |
The EVS 4343(G) complies with the following international and FDA-recognized consensus standards:
| AAMI ANSI ES60601-1: | Medical Electrical Equipment -- Part 1: General Requirements for Basic
Safety And Essential Performance (IEC 60601-1:2005, Mod) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: General Requirements For Basic
Safety And Essential Performance - Collateral Standard: Electromagnetic
Compatibility - Requirements And Tests (Edition 3) |
| ISO 14971: | Medical Devices - Application of Risk Management to Medical Devices.
(General I (QS/RM)) |
| IEC 62220-1: | Medical electrical equipment - Characteristics of digital X-ray imaging
devices - Part 1: Determination of the detective quantum efficiency |
| NEMA PS 3.1 - 3.20: | Digital Imaging and Communications in Medicine (DICOM) Set |
11. Summary of Clinical Data [21 CFR 807.92(b)(2)]
A single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted, and the study confirmed that the new x-ray detectors EVS 4343G provide images of equivalent diagnostic capability to the predicate devices (K142475 and K150766) and its results demonstrate substantial equivalence.
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note X-ray detector technology that is identical to the predicate device) but they provide further evidence in addition to the laboratory performance data to show that the subject device works as intended.
12. Conclusion [21 CFR 807.92(b)(3)]
The modified EVS 4343(G) is substantially equivalent to the currently marketed and predicate device (EVS 4343, K142475) in terms of design features, 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-recogmized consensus standards, IEC60601-1, IEC 60601-1-2, IEC6220-1 and IEC 62133 and the clinical test, 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 EVS 4343(G) meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing, and clinical image concurrence data demonstrates that the device is as safe, as effective, and performs as well or better than the predicate devices.