(133 days)
Not Found
No
The summary focuses on hardware changes (flexible substrate, pixel pitch) and standard image processing software. There is no mention of AI, ML, or related concepts like deep learning, training data, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an X-ray detector designed for digital imaging solutions in general radiographic diagnosis. Its purpose is to produce images for diagnostic procedures, not to treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for use in digital imaging solutions for general radiographic diagnosis of human anatomy" and "intended for use in all general diagnostic procedures".
No
The device description clearly details hardware components (Flexible a-Si in the TFT material, plastic substrate, pixel pitch) and performance testing related to these hardware aspects (MTF, DQE, Electrical Safety, Electromagnetic compatibility). While it mentions image processing software, the core device is a physical X-ray detector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "digital imaging solutions for general radiographic diagnosis of human anatomy." This involves imaging the internal structures of the body using X-rays, which is an in vivo (within the living body) process, not in vitro (outside the living body, typically involving samples like blood or tissue).
- Device Description: The description focuses on the physical components and technology of an X-ray detector, which is a piece of medical imaging equipment used directly on patients.
- Input Imaging Modality: The input modality is X-ray, which is an in vivo imaging technique.
- Anatomical Site: The device is used for "General Radiography" of human anatomy, again indicating in vivo use.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Digital X-ray detector, EXPD-N Series, is designed for use in digital imaging solutions for general radiographic diagnosis of human anatomy. This device is intended for use in all general diagnostic procedures, replacing film or screen-based radiographic systems for both adult and paediatric patients. It is not intended for use in mammography.
Product codes
MQB
Device Description
In comparison to existing devices, the new detectors incorporate a Flexible a-Si in the TFT material within the panel. The primary difference from the conventional glass a-Si panel is that the electronic circuits, such as silicon, are deposited on a plastic substrate instead of a glass substrate during the manufacturing of the TFT panel. Since only the material of the substrate on which the silicon is deposited changes, the overall image performance remains unaffected. Another difference is the pixel pitch. While existing products feature only a pixel pitch of 140μm, the new models include an option with a pixel pitch of 100um. The resolution of an X-ray detector has a significant impact on MTF (Modulation Transfer Function) and sensitivity.
The fundamental operational principle of the subject device is the same as that of the predicate device. The EXPD-N series detector is a square plate-shaped indirect conversion device that converts incoming X-rays into visible light. This visible light is subsequently captured by an optical sensor, which produces an electric charge representation of the spatial distribution of the incoming X-ray quanta. Through thin film transistors, the charges are transformed into a modulated electrical signal is amplified, then changed from an analog to digital form (from voltage to signal) so that it can be printed out, sent for remote viewing, or saved 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
General Radiography / human anatomy
Indicated Patient Age Range
adult and paediatric patients
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)
Non-clinical performance testing in major physical values, such as MTF and DQE, performed in comparison with the predicate device for evaluation. Additionally, clinical images acquired from various anatomical sites were reviewed by qualified expert clinicians to assess imaging performance. The results demonstrated that the device produces accurate X-ray images suitable for diagnostic purposes. Besides performance testing in comparison with predicate device, Electrical Safety testing and Electromagnetic compatibility testing was performed in accordance with IEC 60601-1 and IEC 60601-1-2, and results met the requirements.
The clinical studies are not required as there are no significant changes that requires assess of the performance made in the subject device, such as new indication, and non-clinical testing demonstrated equivalency to the predicate device sufficiently.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 19, 2025
Image /page/0/Picture/1 description: The image shows 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 % Juhee Lee Official Correspondent 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: K243443
Trade/Device Name: Expd 4343n; Expd 4343n; Expd 4343nu; Expd 4343np; Expd 3643n1; Expd 3643n; Expd 3643u1; Expd 3643nu; Expd 3643np Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: November 12, 2024 Received: February 19, 2025
Dear Juhee Lee:
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,
Digitally signed Gabriela for by Gabriela M. M. Rodal -S Rodal -S
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) | K243443 |
|---|---|
| Device Name | EXPD 4343N1; |
| EXPD 4343N; | |
| EXPD 4343U1; | |
| EXPD 4343NU; | |
| EXPD 4343NP; | |
| EXPD 3643N1; | |
| EXPD 3643N; | |
| EXPD 3643U1; | |
| EXPD 3643NU; | |
| EXPD 3643NP | |
| Indications for Use (Describe) | The Digital X-ray detector, EXPD-N Series, is designed for use in digital imaging solutions for general radiographic diagnosis of human anatomy. This device is intended for use in all general diagnostic procedures, replacing film or screen-based radiographic systems for both adult and paediatric patients. It is not intended for use in mammography. |
| 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, 2 Floor/ Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seognam-si, Gyeonggi-do, 13216, Republic of Korea
510(k) Summary (K243443)
These 510(k) summaries of safety and effectiveness information is prepared in accordance with 21 CFR 807.92.
1. Date Prepared [21 CFR 807.92(a) (1)]
March 19, 2025
.
.
2. Submitter's Information [21 CFR 807.92(a) (1)]
-
DRTECH Corporation ● Company Name:
. Address: Suite No. 1, 2 Floor/ Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seognamsi, Gyeonggi-do, 13216, Republic of Korea -
. Contact Person: Juhee Lee
-
. + 82-31-779-7742 Phone:
-
. Fax: +82-31-779-7790
-
. Email: drtechra@drtech.com
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)|
EXPD 4343N1, EXPD 4343N, EXPD 4343U1,
- EXPD 4343NU, EXPD 4343NP,
- Trade/ Device Name: EXPD 3643N1, EXPD 3643N, EXPD 3643U1,
- EXPD 3643NU, EXPD 3643NP
- . Common Name: Digital Flat Panel X-ray Detector
- . Classification Name: Stationary X-ray System
- . Classification Panel: Radiology
- Product Code: MOB
- . Regulation Number: 21 CFR 892.1680
- . Device Class: II
Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] 4.
The identified predicate device(s) within this submission are as follows:
- 510(k) Number: K193017
- . Manufacturer: DRTECH Corporation
- Common Name: Digital Flat Panel X-ray Detector
II
- EVS 4343W, EVS 4343WG, EVS 4343WP, . Trade Name:
- EVS 3643W, EVS 3643WG, EVS 3643WP
- . Classification Name: Stationary X-ray System
- . Classification Panel: Radiology
- . Product Code: MOB
- Regulation Number: 21 CFR 892.1680 ●
- Device Class:
5
Description of the Device [21 CFR 807.92(a) (4)] 5.
In comparison to existing devices, the new detectors incorporate a Flexible a-Si in the TFT material within the panel. The primary difference from the conventional glass a-Si panel is that the electronic circuits, such as silicon, are deposited on a plastic substrate instead of a glass substrate during the manufacturing of the TFT panel. Since only the material of the substrate on which the silicon is deposited changes, the overall image performance remains unaffected.
Another difference is the pixel pitch. While existing products feature only a pixel pitch of 140μm, the new models include an option with a pixel pitch of 100um. The resolution of an X-ray detector has a significant impact on MTF (Modulation Transfer Function) and sensitivity.
Indications for Use [21 CFR 807.92(a) (5)] 6.
The Digital X-ray detector, EXPD-N Series, is designed for use in digital imaging solutions for general radiographic diagnosis of human anatomy. This device is intended for use in all general diagnostic procedures, replacing film or screen-based radiographic systems for both adult and paediatric patients.
It is not intended for use in mammography.
7. Technological Characteristics [21 CFR 807.92(a) (6)]
The fundamental operational principle of the subject device is the same as that of the predicate device. The EXPD-N series detector is a square plate-shaped indirect conversion device that converts incoming X-rays into visible light. This visible light is subsequently captured by an optical sensor, which produces an electric charge representation of the spatial distribution of the incoming X-ray quanta.
Through thin film transistors, the charges are transformed into a modulated electrical signal is amplified, then changed from an analog to digital form (from voltage to signal) so that it can be printed out, sent for remote viewing, or saved as an electronic data file for later viewing.
| Item | Subject Device(EXPD 4343S) | Predicate Device(EXPD 4343P) |
|---|---|---|
| 510(k) No. | K243443 | K193017 |
| Manufacturer | DRTECH Corporation | DRTECH Corporation |
| Trade/ device Name | EXPD 4343N1, EXPD 4343N, | |
| EXPD 4343U1, EXPD 4343NU, | ||
| EXPD 4343NP, | ||
| EXPD 3643N1, EXPD 3643N, | ||
| EXPD 3643U1, EXPD 3643NU, | ||
| EXPD 3643NP | EVS 4343W, EVS 4343WG, EVS 4343WP | |
| EVS 3643W, EVS 3643WG, EVS 3643WP | ||
| Classification Name | Stationary X-ray System | Same |
| Classification | ||
| Regulation | 21 CFR 892.1680 | Same |
| Product Code | MQB | Same |
| Device Class | Class II | Same |
| Item | Subject Device(EXPD 4343S) | Predicate Device(EXPD 4343P) |
| Intended Use | The Digital X-ray detector, EXPD-N Series, | |
| is designed for use in digital imaging | ||
| solutions for general radiographic diagnosis | ||
| of human anatomy. This device is intended | ||
| for use in all general diagnostic procedures, | ||
| replacing film or screen-based radiographic | ||
| systems for both adult and paediatric | ||
| patients. | ||
| It is not intended for use in mammography. | EVS 4343W / EVS 4343WG / EVS 4343WP | |
| / EVS 3643W / EVS 3643WG / EVS | ||
| 3643WP Digital X-ray detector is indicated | ||
| for digital imaging solution designed for | ||
| providing general radiographic diagnosis of | ||
| human anatomy. This device is intended to | ||
| replace film or screen based radiographic | ||
| systems in all general purpose diagnostic | ||
| procedures. This device is not intended for | ||
| mammography applications. | ||
| Anatomical Sites | General Radiography | Same |
| Dimensions | ||
| (mm) | - EXPD 3643N/ EXPD 3643NP/ EXPD 3643NU | |
| / EXPD 3643N1/ EXPD 3643U1: | ||
| 460(W) x 386(L) x 15.5(H) |
- EXPD 4343N/ EXPD 4343NP/ EXPD 4343NU
/ EXPD 4343N1/ EXPD 4343U1:
460(W) x 460(L) x 15.5(H)mm | - EVS 3643W/ EVS 3643WG/ EVS 3643WP:
460(W) x 386(L) x 15(H)mm - EVS 4343W/ EVS 4343WG/ EVS 4343WP:
460(W) x 460(L) x 15(H)mm |
| Pixel Pitch | - EXPD 4343N / EXPD 4343NP /
EXPD 4343NU / EXPD 3643N /
EXPD 3643NP / EXPD 3643NU : 140 μm - EXPD 4343N1 / EXPD 4343U1 /
EXPD 3643N1 / EXPD 3643U1 : 100 μm | 140μm |
| Image Size
(pixels) | - EXPD 4343N / EXPD 4343NP /
EXPD 4343NU : 3,072 × 3,072 - EXPD 3643N / EXPD 3643NP /
EXPD 3643NU : 2,560 × 3,072 - EXPD 4343N1 / EXPD 4343U1 : 4,302 × 4,302
- EXPD 3643N1 / EXPD 3643U1 :
3,534 × 4,302 | - EVS 3643W/ EVS 3643WG/ EVS 3643WP:
2,560 x 3,072 - EVS 4343W/ EVS 4343WG/ EVS 4343WP:
3,072 x 3,072 |
| Active Area
(mm) | - EXPD 4343N / EXPD 4343NP /
EXPD 4343NU : 430.2mm × 430.2mm - EXPD 3643N / EXPD 3643NP /
EXPD 3643NU : 353.4mm × 430.2mm - EXPD 4343N1 / EXPD 4343U1 :
430.08mm × 430.08mm - EXPD 3643N1 / EXPD 3643U1 :
358.4mm × 430.08mm | - EVS 3643W/ EVS 3643WG/ EVS 3643WP:
430mm x 358 - EVS 4343W/ EVS 4343WG/ EVS 4343WP:
430 x 430 |
| TFT Material | - EXPD 4343N1/ EXPD 4343N/ EXPD 3643 N1/
EXPD 3643N: a-Si - EXDP 4343U1/ EXPD 4343NU/ EXPD 3643U1
/ EXPD 3643 NU: Flexible a-Si - EXPD 4343NP/ EXPD 3643NP: IGZO | - EVS 3643W/ EVS 4343W/
EVS 3643WG/ EVS 4343WG: a-Si - EVS 4343WP/ EVS 3643WP: IGZO |
| Cycle Time |