(69 days)
Not Found
No
The document describes a standard digital X-ray detector and its image capture process. There is no mention of AI, ML, or any advanced image processing techniques that would typically involve these technologies. The performance metrics and comparisons are based on traditional X-ray device characteristics like DQE and MTF.
No
This device is an X-ray detector used for diagnostic imaging, not for therapeutic purposes. It captures images to aid in diagnosis, it does not treat conditions.
Yes
The "Intended Use / Indications for Use" section states: "The EXPD 4343D and EXPD 3643D Digital X-ray detector are indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This explicitly states its use for diagnosis.
No
The device description clearly states it is a "flat-panel type digital X-ray detector" and describes its physical components and how it captures images, indicating it is a hardware 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 internal structures of the human body, which is a function of medical imaging devices, not IVDs.
- Device Description: The description details how the device captures X-ray images and converts them into digital signals for viewing. This process is entirely focused on capturing images of the body, not on analyzing samples taken from the body (which is the core function of IVDs).
- Input Imaging Modality: The input modality is X-ray, which is a form of medical imaging, not a method used for analyzing biological samples in vitro.
IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests. It is a medical imaging device.
N/A
Intended Use / Indications for Use
The EXPD 4343D and EXPD 3643D Digital X-ray detector are indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This devices are intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This devices are not intended for mammography applications.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The EXPD 4343D, EXPD 3643D are 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. EXPD 4343D, EXPD 3643D 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 EXPD 4343D, EXPD 3643D Detector are indirect conversion devices 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 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.
Mentions image processing
Yes
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)
The non-clinical performance testing constrains the main physical values for comparison of X-ray devices like DQE and MTF are basically equal or worth the predicate device as the following table:
| Parameter | Subject Device | Predicate Device |
|---|---|---|
| DQE | Typ. 55.0 % at 1.0 lp/mm | EVS 4343A: 52.9% at 1.0 lp/mm |
| EVS 3643A: 50.5 % at 1.0 lp/mm | ||
| MTF | Typ. 40.0 % at 2.0 lp/mm | EVS 4343A: 44.1% at 2.0 lp/mm |
| EVS 3643A: 44.5 % at 2.0 lp/mm |
The results of these tests demonstrate that The EXPD 4343D and EXPD 3643D meet the acceptance criteria and are adequate for this intended use.
The comparison of technological characteristics, nonclinical performance data, and safety testing demonstrates that the device is as effective, and performs as well or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DQE: Typ. 55.0 % at 1.0 lp/mm
MTF: Typ. 40.0 % 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.
0
November 16, 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 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.
DRTECH Corporation % Kim Minjeong Manager Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-Daero 541 Beon-Gil Jungwon-Gu Seongnam-Si, Gyeonggi-Do 13216 SOUTH KOREA
Re: K232753
Trade/Device Name: EXPD 4343D, EXPD 3643D Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: September 8, 2023 Received: October 23, 2023
Dear Kim Minjeong:
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 (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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232753
Device Name EXPD 4343D, EXPD 3643D
Indications for Use (Describe)
The EXPD 4343D and EXPD 3643D Digital X-ray detector are indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This devices are intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This devices are 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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3
510(k) Summary - K232753
[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)]
09/08/2023
2. Submitter's Information [21 CFR 807.92(a) (1)]
-
Name of Sponsor: DRTECH Corporation Address: Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, ●
Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea -
Contact Name: Minjeong Kim
-
- 82-31-779-7783 Telephone No.: ●
-
Fax No.: + 82-31-779-7790
-
Email Address : drtechra@drtech.com ●
-
Registration Number: 3005172103 .
-
Name of Manufacturer: Same as Sponsor ●
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)|
| • Trade Name: | EXPD 4343D, EXPD 3643D |
|---|---|
| --------------- | ------------------------ |
- 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: | K192400 |
|---|---|
| - - - - - - - - - - - - - - - - - - - - - - - - | ADTECH C - ------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- DRTECH Corporation ● Applicant: Trade Name:
- EVS 4343A, EVS 3643A 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)]
Addition of EXPD 4343D, EXPD 3643D : The differences between the subject devices and the predicate devices are TFT Panel and performance (MTF & DQE). Predicate devices used Amorphous silicon TFT, however, subject devices use IGZO TFT.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Model Name | EXPD 4343D, EXPD 3643D | EVS 4343A, EVS 3643A | |
| TFT panel | IGZO | Amorphous Silicon | |
| Performance | DQE | Typ. 55.0 % at 1.0 lp/mm | EVS 4343A: 52.9% at 1.0 lp/mm |
| EVS 3643A: 50.5 % at 1.0 lp/mm | |||
| MTF | Typ. 40.0 % at 2.0 lp/mm | EVS 4343A: 44.1% at 2.0 lp/mm | |
| EVS 3643A: 44.5 % at 2.0 lp/mm |
6. Indication for Use [21 CFR 807.92(a)(5)]
The EXPD 4343D and EXPD 3643D Digital X-ray detector are indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This devices are intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This devices are not intended for mammography applications.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The EXPD 4343D, EXPD 3643D are 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. EXPD 4343D, EXPD 3643D 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 EXPD 4343D, EXPD 3643D Detector are indirect conversion devices 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 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.
5
DRTECH
-
- Firmware
- Level of Concern : Moderate
: DRTECH Firmware includes System Module, Control Module, Image Acquisition Module, Network Module. System Module performs various tasks and initialization for stable system operation and manages the overall system. The control module controls electronic equipment necessary for the detector system drive to S / W and operates according to the purpose. The Image Acquisition Module obtains the image according to the scenario required from PC. The obtained image is assigned to the memory. The network module transmits and receive the information which is necessary for the system drive and image acquisition to the TCP / IP Socket communication.
Image /page/5/Figure/5 description: The image shows a diagram of the DRTECH Firmware System. The system consists of four components: Network, Image Acquisition, Control, and System. The DRTECH Firmware System is connected to a PC API through a network.
6
8. Substantial Equivalence [21 CFR 807.92(b)]
| Parameter | Subject Device | Predicate Device | |
|---|---|---|---|
| 510(K) Number | Unknown | K192400 | |
| Manufacturer | DRTECH Corporation | DRTECH Corporation | |
| Model Name | EXPD 4343D, EXPD 3643D | EVS 4343A, EVS 3643A | |
| Classification Name | Stationary X-ray System | Stationary X-ray System | |
| Classification Panel | Radiology | Radiology | |
| Classification | |||
| Regulation | 21 CFR 892.1680 | 21 CFR 892.1680 | |
| Product Code | MQB | MQB | |
| Device Class | Class II | Class II | |
| Intended Use | The EXPD 4343D, EXPD 3643D Digital | ||
| X-ray detector are indicated for digital | |||
| imaging solution designed for providing | |||
| general radiographic diagnosis of human | |||
| anatomy. This devices are intended to | |||
| replace film or screen based radiographic | |||
| systems in all general purpose diagnostic | |||
| procedures. This devices are not intended | |||
| for mammography applications. | The EVS 4343A / EVS 3643A 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 | EXPD 4343D : Square Panel | ||
| EXPD 3643D : Rectangular Panel | EVS 4343A: Square Panel | ||
| EVS 3643A: Rectangular Panel | |||
| Detector | |||
| Size | EXPD 4343D : 17" x 17" | ||
| EXPD 3643D : 13" x 17" | EVS 4343A: 17" x 17" | ||
| EVS 3643A: 13" x 17" | |||
| Design | Dimensions | EXPD 4343D | |
| : 460(W) x 483(L) x 15.5(H) | |||
| EXPD 3643D | |||
| : 460(W) × 409 (L) × 15.5 (H) | EVS 4343A | ||
| : 460(W) x 483(L) x 15.5(H) | |||
| EVS 3643A | |||
| : 460(W) × 409(L) × 15.5(H) | |||
| Pixel Pitch | 140μm | 140μm | |
| Image Size | EXPD 4343D: 3,072 x 3,072 | ||
| EXPD 3643D: 2,560 x 3,072 | EVS 4343A: 3,072 x 3,072 | ||
| EVS 3643A: 2,560 x 3,072 | |||
| Panel & Scintillator | |||
| Materials | Panel Material : TFT - IGZO | ||
| Scintillator Material : CsI | Panel Material : TFT - amorphous | ||
| Silicon | |||
| Scintillator Material : CsI |
7
DRTECH Corporation Suite No.1, 2 Floor / Suite No. 2, Dunchon-Daero 541beon-gil, Jung Gyeonggi-do, 13216, Republic of
Typ. 55.0 %
Parameter
Perfor-
DQE
| Subject Device | Predicate Device |
|---|---|
| EVS 4343A: 52.9% at 1.0 lp/mm | |
| at 1.0 lp/mm | EVS 3643A: 50.5 % at 1.0 lp/mm |
| EVS 4343A: 44.1% at 2.0 lp/mm | |
| at 2.0 lp/mm | EVS 3643A: 44.5 % at 2.0 lp/mm |
| mance | MTF | Typ. 40.0 % at 2.0 lp/mm | EVS 4343A: 44.1% at 2.0 lp/mm |
|---|---|---|---|
| EVS 3643A: 44.5 % at 2.0 lp/mm | |||
| Resolution | 3.5 lp/mm | 3.5 lp/mm | |
| Anatomical Sites | General Radiography | General Radiography | |
| Power Supply | 100-240V~, 50-60 Hz | 100 | |
| Components | POE Adaptor & AC Power Cord | ||
| LAN Cable A | |||
| LAN Cable B | |||
| SYNC Cable | PoE Adaptor | ||
| Lan cables(2 ea) | |||
| AC Power Cable | |||
| Ethernet Connector Bracket | |||
| Communication | |||
| Interface | Wired: Ethernet | Wired: Ethernet | |
| Software | (Image | ||
| Processing Program) | EConsole1(K152172) | EConsole1(K152172) |
When compared to the predicate devices (K192400), the EXPD 4343D, EXPD 3643D presented in this submission have similar:
- . Intended Use
- Technological characteristics .
- Operating principle .
- . Performance (Resolution)
- Communication Method .
- Components .
- Size Intended Use .
- Software (Image Processing Program) .
A few differences are as follows
- . Panel Material
- . Performance (DQE and MTF)
There are no significant differences between the EXPD 4343D, EXPD 3643D 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.
8
DRTECH
10. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
The non-clinical performance testing constrains the main physical values for comparison of X-ray devices like DQE and MTF are basically equal or worth the predicate device as the following table:
| Parameter | Subject Device | Predicate Device |
|---|---|---|
| DQE | Typ. 55.0 % at 1.0 lp/mm | EVS 4343A: 52.9% at 1.0 lp/mm |
| EVS 3643A: 50.5 % at 1.0 lp/mm | ||
| MTF | Typ. 40.0 % at 2.0 lp/mm | EVS 4343A: 44.1% at 2.0 lp/mm |
| EVS 3643A: 44.5 % at 2.0 lp/mm |
The EXPD 4343D, EXPD 3643D detector comply with the following international and FDA-recognized consensus standards:
| Recognition
No. | Standard No. | Title of Standard | Date of
Recognition | Remark |
|--------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|--------|
| 5-125 | ISO 14971 Third Edition
2019-12 | Medical devices - Application of risk
management to medical devices | 12/23/2019 | |
| 19-46 | ANSI AAMI ES60601-
1:2005/(R)2012 & A1:2012,
C1:2009/(R)2012 &
A2:2010/(R)2012 (Cons.
Text) [Incl. AMD2:2021] | Medical electrical equipment - Part 1:
General requirements for basic safety and
essential performance (IEC 60601-
1:2005, MOD) [Including Amendment 2
(2021)] | 05/30/2022 | |
| 19-36 | IEC 60601-1-2 Edition 4.1
2020-09 CONSOLIDATED
VERSION | Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests | 12/21/2020 | |
| 5-132 | IEC 60601-1-6 Edition 3.2
2020-07 CONSOLIDATED
VERSION | Medical electrical equipment - Part 1-6:
General requirements for basic safety and
essential performance - Collateral
standard: Usability | 12/21/2020 | |
9
DRTECH
| Recognition
No. | Standard No. | Title of Standard | Date of
Recognition | Remark |
|--------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|--------|
| 5-129 | IEC 62366-1 Edition 1.1
2020-06 CONSOLIDATED
VERSION | Medical devices - Part 1: Application of
usability engineering to medical devices | 07/06/2020 | |
| 13-79 | IEC 62304 Edition 1.1 2015-
06 CONSOLIDATED
VERSION | Medical device software - Software life
cycle processes | 01/14/2019 | |
| 12-349 | NEMA PS 3.1 - 3.20 2022d | Digital Imaging and Communications in
Medicine (DICOM) Set | 12/19/2022 | |
| 12-289 | IEC 62220-1-1 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 | 08/14/2015 | |
11. Related FDA Guidance documents
We reviewed the below FDA guidance documents and it was reflected in the development of the modified EXPD 4343D, EXPD 3643D detector.
| Title of Guidance | Remark |
|---|---|
| Content of Premarket Submissions for Management of Cybersecurity in Medical Devices | |
| Pediatric Information for X-ray Imaging Device Premarket Notifications |
10
DRTECH
12. Conclusion [21 CFR 807.92(b)(3)]
The modified EXPD 4343D and EXPD 3643D detectors(K232753) are substantially equivalent to the currently marketed and predicate device (K192400) 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/AMD2:2021, IEC 60601-1-2:2020, IEC 60601-1-6 Edition 3.2, IEC 62304:2015 and IEC 6220-1-1 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 EXPD 4343D and EXPD 3643D meet the acceptance criteria and are adequate for this intended use. The comparison of technological characteristics, nonclinical performance data, and safety testing demonstrates that the device is as effective, and performs as well or better than the predicate devices.