(188 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 advanced image processing techniques that would typically indicate the presence of such technology.
No.
The device is indicated for "digital imaging solution designed for providing general radiographic diagnosis of human anatomy" and is not mentioned for treating or curing a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for furnishing general radiographic diagnosis". It also says the device "is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures."
No
The device description explicitly 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EXPD 114 series is a digital X-ray detector. Its function is to capture radiographic images of the human anatomy using X-rays. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states "digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This is a diagnostic imaging device, not an in vitro diagnostic device.
Therefore, the EXPD 114 series falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
EXPD 114, EXPD 114P, EXPD 114G, EXPD 114PG 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. It is intended for both adult and pediatric populations.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG 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 114, EXPD 114G, EXPD 114P, EXPD 114PG 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.
EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
General Radiography (human anatomy)
Body parts (Chest, C-spine AP, L-spine AP, Shoulder AP, Pelvis AP, Extremity)
Indicated Patient Age Range
adult and pediatric populations
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)
Performance:
Non-clinical performance testing (Bench Test) was conducted to compare DQE and MTF values of the subject device and the predicate device.
- DQE:
- Subject Device: EXPD 114: 45% @0.5lp/mm, EXPD 114G: 25% @0.5lp/mm, EXPD 114P: 45% @0.5lp/mm, EXPD 114PG: 25% @0.5lp/mm
- Predicate Device: EXPD 129P, EXPD 86P: 50.0 % at 0.5 lp/mm, EXPD 129PG, EXPD 86PG: 25.0 % at 0.5 lp/mm
- MTF:
- Subject Device: EXPD 114: 40% @2.0lp/mm, EXPD 114G: 40% @2.0lp/mm, EXPD 114P: 40% @2.0lp/mm, EXPD 114PG: 40% @2.0lp/mm
- Predicate Device: EXPD 129P, EXPD 86P: 45.0 % at 2.0 lp/mm, EXPD 129PG, EXPD 86PG: 45.0 % at 2.0 lp/mm
The DQE and MTF values are basically equal to or worth the predicate device.
Firmware:
Firmware Validation and Verification has been conducted according to the FDA guidance document "Content of Premarket Submissions for Device Software Functions".
Cybersecurity:
Cybersecurity Testing was performed in accordance with the guidance of "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions ".
Clinical Study:
A Concurrence Study for Image Quality was based on body parts (Chest, C-spine AP, L-spine AP, Shoulder AP, Pelvis AP, Extremity) to compare the subject device and predicate device (K223124).
In this Concurrence Study, a qualified clinical expert confirmed that the image quality of the subject device is equivalent to that of the predicate device, demonstrating that the subject device meets the diagnostic quality of the predicate device.
The results demonstrate that EXPD 114G, EXPD 114P, EXPD 114PG meet the acceptance criteria and are 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2025
DRTECH Corporation % Yeongsuk An Assistant Manager Suite No. 1, 2 Floor/Suite No. 2, 3 Floor 29, Dunchon-daero 541beon-gil Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216 SOUTH KOREA
Re: K242770
Trade/Device Name: EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: September 13, 2024 Received: February 18, 2025
Dear Yeongsuk An:
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 (the 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.
1
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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 Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K242770
Device Name
EXPD 114: EXPD 114G;
EXPD 114P; EXPD 114PG
Indications for Use (Describe)
EXPD 114, EXPD 114P, EXPD 114G, EXPD 114PG 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. It is intended for both adult and pediatric populations.
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
K242770
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)]
February/18/2025
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: Yeongsuk, An
-
- 82-31-779-7787 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 114; EXPD 114G; EXPD 114P; EXPD 114PG
- 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: | K223124 |
|---|---|
| Applicant: | DRTECH Corporation |
| Trade Name: | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PC |
| Classification Name: | Radiology |
- Classification Panel: ● Stationary X-ray System
- Classification Regulation: 21 CFR 892.1680
- Product Code: MQB
- Device Class: II ●
5
5. Description of the Modified Device [21 CFR 807.92(a) (4)]
Addition of EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG : The differences between the subject devices and the predicate devices are Dimension , TFT panel material, and Components(optional). The Dimension of Subject devices is shorter than predicate devices.
6. Indication for Use [21 CFR 807.92(a)(5)]
EXPD 114, EXPD 114P, EXPD 114G, EXPD 114PG 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. It is intended for both adult and pediatric populations.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG 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 114, EXPD 114G, EXPD 114P, EXPD 114PG 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.
EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG 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 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.
6
DRTECH
8. Integrated Configuration for X-Ray system
EXPD 114, EXPD 114G, EXPD 114PG are connected with General diagnostic X-ray system.
Image /page/6/Figure/4 description: This image shows a diagram of an X-ray system. The diagram includes a detector, an X-ray system, a console, and a hospital network. The detector is connected to the power source via a POE cable, and it is also connected to the X-ray system via a SYNC cable. The console is connected to the detector via a LAN cable, and it is connected to the hospital network via an Ethernet cable.
| No. | Component | Description |
|---|---|---|
| ① | POE Cable | 1) DC 24V voltage |
- It is supplied from Adaptor to Detector. |
| ② | LAN Cable | 1) Gigabit Ethernet Communications - It is transmitted from the detector to the CONSOLE PC. |
| ③ | SYNC Cable | 1) two-way TTL communication - It is communicated between the detector and the X-ray System Generator. |
| ④ | Ethernet Cable | 1) DICOM communication - It is transmitted from the CONSOLE PC to the hospital network. |
7
For successful integration of detector with X-ray system, we designed the hardware of EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG as below function. The Energy of generator is controlled by Radiography imaging software(Econsole2, K240343), not firmware of Detector.
| Mode | Description |
|---|---|
| AED/AWC Mode | The detector detects actual amount of X-rays without any connection to the X-ray |
| generator. | |
| No signal used (No need of connector interface cable) | |
| Sync. Trigger Mode | The detector receives EXP_REQ signal that X-ray generator is prepared to |
| generate X-rays. | |
| The detector prepares image acquiring and then responds EXP_OK signal to the | |
| X-ray generator. | |
| The X-ray generator confirms EXP_OK signal and generates X-ray, then the | |
| detector performs image acquiring, according to image acquisition time and | |
| transmits the image data. | |
| EXP_REQ (Generator→ Detector), EXP_OK (Detector →Generator) |
8
9. Substantial Equivalence [21 CFR 807.92(b)]
| Parameter | Subject Device | Predicate Device | |
|---|---|---|---|
| 510(K) Number | Unknown | K223124 | |
| Manufacturer | DRTECH Corporation | DRTECH Corporation | |
| Model Name | EXPD 114, EXPD 114G, EXPD 114P, | ||
| EXPD 114PG | EXPD 86P, EXPD 86PG, | ||
| EXPD 129P, EXPD 129PG | |||
| 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 | EXPD 114, EXPD 114P, EXPD 114G, | ||
| EXPD 114PG 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 EXPD 86P/ EXPD 86PG/ EXPD | ||
| 129P/ EXPD 129PG 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 | Rectangular Panel | EXPD 129P, EXPD 129PG, EXPD 86P, | |
| EXPD 86PG : Rectangular Panel | |||
| Detector | |||
| Size | 17" × 46" | EXPD 129P, EXPD 129PG | |
| : 17" × 51" | |||
| EXPD 86P, EXPD 86PG | |||
| : 17" × 34" | |||
| Design | Dimensions | 460mm (W) × 1,178mm (L) × 20mm (H) | |
| [±0.5mm] | EXPD 129P, EXPD 129PG | ||
| : 460mm (W) × 1324mm (L) × 20mm | |||
| (H) [±0.5mm] | |||
| EXPD 86P, EXPD 86PG | |||
| : 460mm (W) × 894.14mm (L) × 15.5mm | |||
| (H) [±0.5mm] | |||
| Pixel Pitch | 140μm | 140μm | |
| Image Size | 3,072 × 8,192 | EXPD 129P, EXPD 129PG | |
| : 3,072 × 9,216 | |||
| EXPD 86P, EXPD 86PG | |||
| : 3,072 × 6,144 | |||
| Parameter | Subject Device | Predicate Device | |
| Panel & Scintillator | |||
| Materials | Panel Material |
- EXPD 114, EXPD 114G: TFT -
amorphous Silicon - EXPD 114P, EXPD 114PG : TFT -
IGZO | TFT - amorphous Silicon |
| | | Scintillator Material
EXPD 114, EXPD 114P: CsI
EXPD 114G, EXPD 114PG: Gadox, | Scintillator Material - EXPD 129P, EXPD 86P: CsI
- EXPD 129PG, EXPD 86PG: Gadox |
| Perfor-
mance | DQE | EXPD 114: 45% @0.5lp/mm
EXPD 114G: 25% @0.5lp/mm
EXPD 114P : 45% @0.5lp/mm
EXPD 114PG: 25% @0.5lp/mm | EXPD 129P, EXPD 86P
: 50.0 % at 0.5 lp/mm
EXPD 129PG, EXPD 86PG
: 25.0 % at 0.5 lp/mm |
| | MTF | EXPD 114: 40% @2.0lp/mm
EXPD 114G: 40% @2.0lp/mm
EXPD 114P : 40% @2.0lp/mm
EXPD 114PG: 40% @2.0lp/mm | EXPD 129P, EXPD 86P
: 45.0 % at 2.0 lp/mm
EXPD 129PG, EXPD 86PG
: 45.0 % 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 | 100240V, 50/60 Hz |
| Components | | Adaptor & AC Power Cord
POE Cable
SYNC Cable
LAN Cable | Adaptor & AC Power Cord
LLD POE Cable
LLD Sync Cable |
| Communication
Interface | | Wired: Ethernet | Wired: Ethernet |
| Diagram | | Image: Diagram of the subject device | Image: Diagram of the predicate device |
9
DRTECH
10
DRTECH
When compared to the predicate devices (K223124), the EXPD 114G, EXPD 114G, EXPD 114PG presented in this submission have similar:
- Intended Use •
- Technological characteristics
- . Operating principle
- Performance (Resolution)
- . Communication Method
A few differences are as follows
- Image Size •
- . Active area
- . TFT panel
- MTF and DQE
- Components (optional)
11
10. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
For Performance
The non-clinical performance testing(Bench Test) and Concurrence Study 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 | EXPD 114: 45% @0.5lp/mm | |
| EXPD 114G: 25% @0.5lp/mm | ||
| EXPD 114P: 45% @0.5lp/mm | ||
| EXPD 114PG: 25% @0.5lp/mm | EXPD 129P, EXPD 86P | |
| : 50.0 % at 0.5 lp/mm | ||
| EXPD 129PG, EXPD 86PG | ||
| : 25.0 % at 0.5 lp/mm | ||
| MTF | EXPD 114: 40% @2.0lp/mm | |
| EXPD 114G: 40% @2.0lp/mm | ||
| EXPD 114P: 40% @2.0lp/mm | ||
| EXPD 114PG: 40% @2.0lp/mm | EXPD 129P, EXPD 86P | |
| : 45.0 % at 2.0 lp/mm | ||
| EXPD 129PG, EXPD 86PG | ||
| : 45.0 % at 2.0 lp/mm |
For Firmware
Firmware Validation and Verification has been conducted according to the FDA guidance document "Content of Premarket Submissions for Device Software Functions".
For Cybersecurity
Cybersecurity Testing was performed in accordance with the guidance of "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions ".
| 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 | |
| Recognition
No. | Standard No. | Title of Standard | Date of
Recognition | Remark |
| 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 | |
| 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 | |
And The EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG comply with the following international and FDA-recognized consensus standards:
12
DRTECH
11. Summary of Clinical Data[21 CFR 807.92(b)(2)]
Our Concurrence Study for Image Quality was based on body parts (Chest, C-spine AP, L-spine AP, Shoulder AP, Pelvis AP, Extremity) to compare subject device and predicate device(K223124). In this Concurrence Study, a qualified clinical expert confirmed that the image quality of the subject device is equivalent to that of the predicate device, demonstrating that the subject device meets the diagnostic quality of the predicate device.
9/10 510(k) Summary
13
12. Related FDA Guidance documents
We reviewed the below FDA guidance documents and it was reflected in the development of the modified EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG.
| Title of Guidance | Remark |
|---|---|
| Guidance for the Submission of 510(k)s for | |
| Solid State X-ray Imaging Devices | |
| Cybersecurity in Medical Devices: Quality System Considerations and Content of | |
| Premarket Submissions | |
| Content of Premarket Submissions for Device Software Functions | |
| Pediatric Information for X-ray Imaging Device Premarket Notifications |
14
13. Conclusion [21 CFR 807.92(b)(3)]
The modified EXPD 114, EXPD 114G, EXPD 114PG are substantially equivalent to the currently marketed and predicate device (K223124) in terms of fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, Substantial equivalence was demonstrated through the non-clinical performance such as Bench Test, Software Validation and Verification, Cybersecurity Testing, 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, IEC 6220-1-1, IEC 81001-5-1 and ANSI UL 2900-1. 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.
Plus, A Concurrence Study was conducted to confirm the clinical equivalence of the subject device with the predicate device. Through the clinical study, it was confirmed that the image quality of the subject device is equivalent to that of the predicate device.
The results of these data demonstrate that EXPD 114G, EXPD 114P, EXPD 114PG meet the acceptance criteria and are 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.