(237 days)
Not Found
No
The document mentions image processing but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description focuses on standard digital radiography console functions and DICOM compliance.
No
The device is described as digital radiography operating console software used for acquiring and processing general radiographic images, which falls under diagnostic imaging rather than therapeutic treatment.
No
The device is an operating console software for X-ray projection that acquires and processes images. It is intended to replace film/screen systems in general-purpose diagnostic procedures but does not perform the diagnosis itself; rather, it handles the images.
Yes
The device description explicitly states "EConsole2 is digital radiography operating console software." While it integrates with a digital detector and other hardware (PACS, DICOM printer), the device itself, as described, is the software component that performs the core functions of acquiring, processing, and managing the radiographic images. The 510(k) summary focuses on the software's functionality and integration, not on the hardware components it interacts with.
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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- EConsole2's Function: EConsole2 is software that processes and manages radiographic images of the human anatomy. It works with an X-ray detector to acquire and process images taken of the body, not from the body.
- Intended Use: The intended use clearly states it's for "general radiographic images of human anatomy" and replaces "radiographic film/screen systems." This is consistent with diagnostic imaging, not in vitro testing.
The description focuses on image acquisition, processing, and management within a radiographic workflow, which is distinct from the analysis of biological specimens.
N/A
Intended Use / Indications for Use
EConsole2 is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications). It is intended for both adult and pediatric populations.
Product codes
LLZ
Device Description
EConsole2 is digital radiography operating console software. EConsole2 provides an integrated solution for X-ray projection. It integrates with the digital detector. Furthermore, EConsole2 acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Human anatomy (general radiographic images)
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)
Not Applicable
Clinical studies are unnecessary to validate the safety and effectiveness of the Radiological Image Processing System, EConsole2, the subject of this 510(k) notification.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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.
DRTECH Corporation An Yeong-Suk Assistant Manager Suite No.1, 2 Floor / Suite No. 2, 3 Floor 29, Dunchon-daero 541 beon-gil, Jungwon-gu Seongnam-si, Gyeonggi-do 13216 Korea, South
Re: K240243
September 23, 2024
Trade/Device Name: EConsole2 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: August 14, 2024 Received: August 14, 2024
Dear An Yeong-Suk:
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/cfpm/pm.cfm identifies combination product submissions. The general controls 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).
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
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-advice-comprehensive-regulatory-assistance/unique-deviceidentification-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-reporting-mdr-how-report-medicaldevice-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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-deviceadvice-comprehensive-regulatory-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,
Jessica Lamb
Jessica Lamb, PhD Assistant Director, Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240243
Device Name EConsole2
Indications for Use (Describe)
EConsole2 is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, and mammographic 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
RTECH
DRTECH Corporation Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea
510(k) Summary
[As required by 21 CFR 807.92]
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
September/20/2024
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-daero 541 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. Identification of the Subject Device [21 CFR 807.92(a) (2)]
| Model Name: | EConsole2 |
|---|---|
| Common Name: | Radiological Image Processing System |
| Classification Name: | Medical image management and processing system |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.2050 |
| Primary Product Code: | LLZ |
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
4.1 Predicate device
- 510(k) Number: K231225 ●
- Applicant: DRTECH Corporation
- . Trade Name: EConsole1
- Classification Name: Medical image management and processing system
- Classification Panel: Radiology ●
- . Classification Regulation: 21 CFR 892.2050
- Product Code: LLZ
- Device Class: II ●
4
DRTECH Corporation
Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea
5. Description of the Device [21 CFR 807.92(a) (4)]
EConsole2 is digital radiography operating console software. EConsole2 provides an integrated solution for X-ray projection. It integrates with the digital detector. Furthermore, EConsole2 acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.
6. Indication for Use [21 CFR 807.92(a)(5)]
EConsole2 is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications). It is intended for both adult and pediations.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The EConsole2 is a x-ray image software device. It can utilize and transfer the digitalizing x-ray images for radiography diagnostic. It can work with Modality worklist, PACS and DICOM Printer to maintain the patient information and the images from flat panel detector.
5
DRTECH
8. Substantial Equivalence Comparison [21 CFR 807.92(b)]
| Parameter | Proposed Device | Predicate Device | Equivalence
Analysis |
|------------------------------|------------------------------------------------|------------------------------------------------|-------------------------|
| 510(k) Number | Unknown | K231225 | N/A |
| Model Name | EConsole2 | EConsole1 | N/A |
| Manufacturer | DRTECH Corporation | DRTECH Corporation | N/A |
| Common Name | Radiological Image Processing System | Radiological Image Processing System | N/A |
| Classification Name | Medical image management and processing system | Medical image management and processing system | N/A |
| Classification Panel | Radiology | Radiology | Equivalence |
| Classification
Regulation | 21 CFR 892.2050 | 21 CFR 892.2050 | Equivalence |
| Product Code | LLZ | LLZ | Equivalence |
| Device Class | Class II | Class II | Equivalence |
6
Image /page/6/Picture/1 description: The image shows the word "DRTECH" in blue font. The letters are spaced apart and are all capitalized. The font is simple and sans-serif.
| Intended Use | EConsole2 is indicated for use in general radiographic
images of human anatomy. It is intended to replace
radiographic film/screen systems in all general-
purpose diagnostic procedures (excluding
fluoroscopic, angiographic, and mammographic
applications). It is intended for both adult and
pediatric populations. | EConsole1 is indicated for use in general
radiographic images of human anatomy. It is
intended to replace radiographic film/screen
systems in all general-purpose diagnostic
procedures (excluding fluoroscopic, angiographic,
and mammographic applications). | Similar | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Software Function | Image acquisition and study
Image search
Image storage
Image annotation
Image measurement
Image stitch
Image processing
Generator Control | Image acquisition and study
Image search
Image storage
Image annotation
Image measurement
Image stitch
Image processing
Generator Control | Similar | |
| DICOM Compliance | Yes | Yes | Equivalence | |
| Software Function | | Technological characteristics | | Equivalence
Analysis |
| | | Proposed Device(Non) | Predicate Device(K231225) | |
| Generator Control | | This function controls the generator to set X-ray
irradiation conditions(such as kVp, mA, mAs, etc.) can
be adjusted. And this function transmit the set data to the
generator. Then It is displayed the set X-ray irradiation
conditions, and displays the image acquired after X-ray
irradiation. | This function controls the generator to set X-ray
irradiation conditions(such as kVp, mA, mAs, etc.)
can be adjusted. And this function transmit the set
data to the generator. Then It is displayed the set
X-ray irradiation conditions, and displays the
image acquired after X-ray irradiation. | Equivalence |
| | | But this control function of EConsole2 does not exerts
control over generator power that produces ionizing
radiation. However, Its does not have control over
exposure, electrical changes, or the calibration of the X-
ray system. | But this control function of EConsole2 does not
exerts control over generator power that produces
ionizing radiation. However, Its does not have
control over exposure, electrical changes, or the
calibration of the X-ray system. | Equivalence |
| DEXi Function | | 1. When generator which supports DEXi and when
examining DEXi, mark the irradiation condition(High
kV, High mA, High mAs, Low kV, Low mA, Low mAs)
and provide button to control the irradiation condition.
2. When changing the irradiation condition, connect with
generator and control the irradiation condition. | 1. When generator which supports DEXi and when
examining DEXi, mark the irradiation
condition(High kV, High mA, High mAs, Low kV,
Low mA, Low mAs) and provide button to control
the irradiation condition.
2. When changing the irradiation condition,
connect with generator and control the irradiation
condition. | Equivalence |
| | Truveiw ART | Increase the sharpness of the obtained x-ray images. | Increase the sharpness of the obtained x-ray
images. | Equivalence |
| Image
Processing(Optional) | ECE Function | ECE function can be applied before the main image
processing. This function normalizes the image
brightness and contrast regardless of the exposed x-ray
dose.
ECE function works as a simple linear transformation to
each pixel value.
To find the slope and the offset of the linear function,
ECE function first finds two or more reference points in
the radiograph. The reference points are selected
depending on the body part and position of the patient.
By using these reference points, we can determine the | N/A | This is new
function of
EConsole2. |
When compared to the predicate devices (K23125), the device proposed in this submission, the followings as the predicate device and reference device:
- Intended Use
- Software function
- Technological characteristics
7
DRTECH
In case of Technological characteristics, all items are the same, but some items have detailed optional functions. Please refer to the below table.
8
DRTECH
| slope and the offset of the linear function.
Finally, by using the inverse of the linear function, the
brightness and the contrast of the radiograph will be
normalized even with different x-ray exposure condition.
And now some desired function, such as gamma
correction or LUT, can be applied.
With ECE function, the main image processing engine
can expect an image with similar brightness and contrast
regardless of the x-ray exposure condition. Therefore, the
resulting radiograph will have more uniform image
quality.
The user cannot change the parameters of this function or
turn it off. Only the engineers can change. And this
function is used for all of the body parts including chest,
| abdomen, pelvis, skull, extremities and etc. | ||
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -- | -- |
9
DRTECH
9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
The EConsole2 complies with the following international and FDA-recognized consensus standards list in Table 2.
| Recognition No. | Standard No. | Title of Standard | Remark |
|---|---|---|---|
| 13-79 | IEC 62304 Edition 1.1 2015-06 | ||
| CONSOLIDATED VERSION | Medical device software - Software | ||
| life cycle processes | |||
| 13-129 | ISO IEC IEEE 29119-1 First | ||
| edition 2013-09-01 | Software and systems engineering - | ||
| Software testing - Part 1: Concepts | |||
| and definitions | |||
| 12-349 | NEMA PS 3.1 - 3.20 2022d | Digital Imaging and | |
| Communications in Medicine | |||
| (DICOM) Set | |||
| 5-135 | ISO 20417 First edition 2021-04 | ||
| Corrected version 2021-12 | Medical devices - Information to be | ||
| supplied by the manufacturer | |||
| 5-129 | IEC 62366-1 Edition 1.1 2020- | ||
| 06 CONSOLIDATED | |||
| VERSION | Medical devices - Part 1: | ||
| Application of usability | |||
| engineering to med | |||
| 5-125 | ISO 14971 Third Edition 2019- | ||
| 12 | Medical devices - Application of | ||
| risk management to medical device | |||
| 13-96 | UL ANSI 2900-1 First Edition | ||
| 2017 | Standard for Safety, Standard for | ||
| Software Cybersecurity Network- | |||
| Connectable Products, Part 1: | |||
| General Requirements |
| Table 2. International and FDA-recognized consensus standards | ||
|---|---|---|
And EConsole2 comply with the FDA guidance documents listed in Table 3.
Table 3. FDA Guidance Documents
| Title of Guidance Document | Issue Date |
|---|---|
| Guidance for Industry and Food and Drug Administration Staff: The 510(k) | |
| Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] | July 28, 2014 |
| Content of Premarket Submissions for Device Software Functions, Guidance for | |
| Industry and Food and Drug Administration Staff | June 14, 2023 |
| Off-The-Shelf Software Use in Medical Devices | August 11, 2023 |
10
DRTECH Corporation
Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea
| Title of Guidance Document | Issue Date |
|---|---|
| Cybersecurity in Medical Devices Quality System Considerations and Content of | |
| Premarket Submissions | September 26, 2023 |
| Pediatric Information for X-ray Imaging Device Premarket Notifications, | |
| Guidance for Industry and Food and Drug Administration Staff | November 28, 2017 |
The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence.
10. Summary of Clinical Data [21 CFR 807.92(b)(2)]
Not Applicable
Clinical studies are unnecessary to validate the safety and effectiveness of the Radiological Image Processing System, EConsole2, the subject of this 510(k) notification.
11. Conclusion [21 CFR 807.92(b)(3)]
The EConsole2 is substantially equivalent to the currently marketed predicate device (K231225, EConsole1) in terms of technical characteristics, general function, applications for use, safety, and effectiveness. Substantial equivalence for Radiological Image Processing System (EConsole2) was demonstrated through the non-clinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards, IEC 62366-1, and UL ANSI 2900-1.
The comparison of technological characteristics, non-clinical performance data and safety testing demonstrate that the EConsole 2 is substantially equivalent to the predicate devices.