(173 days)
K10033
No
The summary mentions "image processing" but provides no details or keywords (like AI, ML, DNN) that would indicate the use of AI/ML technology. The description focuses on standard digital imaging console functionalities like acquisition control, storage, data management, and DICOM compliance.
No
The device is described as software for processing radiographic images and does not provide therapy or treatment.
Yes
The 'Intended Use / Indications for Use' states the device is "intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures". This clearly indicates its use in diagnosis.
Yes
The device is described as "complete digital image processing console software" and its functions are entirely software-based (controlling interfaces, storing data, processing images, complying with DICOM). There is no mention of accompanying hardware that is part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that EConsole1 is for "general radiographic images of human anatomy" and is intended to "replace radiographic film/screen systems in all general-purpose diagnostic procedures." This describes a device used for in vivo imaging (imaging within the living body), not in vitro testing (testing outside the body, typically with biological samples).
- Device Description: The description focuses on processing digital X-ray images acquired from a detector, controlling the X-ray generator, and managing image data. This aligns with an imaging system, not an IVD.
- Input Imaging Modality: The input is "Digital X-ray," which is an imaging modality used on living patients.
- Anatomical Site: The anatomical site is "general radiographic images of human anatomy," again indicating imaging of a living body.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. EConsole1's function is to acquire, process, and manage medical images taken directly from a patient.
N/A
Intended Use / Indications for Use
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, and mammographic applications).
The main features of this software are controlling and interfacing the detector, controlling the x-ray generator acquisition settings, storing acquired images, data management and image processing.
Product codes
LLZ
Device Description
Radiological Image Processing Software, EConsolel is complete digital image processing console software specialized for the digital X-ray detector series developed by DRTECH Corporation.
EConsole1 not only processes the acquired images but also complies with DICOM standards which allow the user 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
Digital X-ray Detector
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel
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)
Clinical studies are unnecessary to validate the safety and effectiveness of the software in EConsole1, the subject of this 510(k) notification.
EConsole1 passed all Verification and Validation testing, which means that the features, functions and technology were all demonstrated to perform well.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K10033
Reference Device(s)
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
October 18, 2023
DRTECH Corporation % Kim Hanbyul 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 SOUTH KOREA
Re: K231225
Trade/Device Name: EConsole1 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 19, 2023 Received: September 19, 2023
Dear Kim Hanbyul:
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.
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).
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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
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Indications for Use
510(k) Number (if known) K231225
Device Name EConsole1
Indications for Use (Describe)
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, and mammographic applications).
The main features of this software are controlling and interfacing the detector, controlling the x-ray generator acquisition settings, storing acquired images, data management and image processing.
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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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)]
October 17, 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-daero 541 beon-gil, ● Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea ● Contact Name: Hanbyul Kim
- Telephone No.: + 82-31-779-7720 ●
- Fax No.: + 82-31-779-7790 ●
- Email Address : hbkim95(@drtech.com ●
- Registration Number: 3005172103
- Name of Manufacturer: Same as Sponsor ●
3. Identification of the Subject Device [21 CFR 807.92(a) (2)]
- Trade Name: EConsole 1
- . Common Name: Radiological Image Processing System
- . Classification Name: Medical image management and processing system
- Classification Panel: ● Radiology
- Classification Regulation: 21 CFR 892.2050 ●
- Product Code: ● LLZ
- . Device Class:
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
II
II
4.1 Primary predicate device
- 510(k) Number: K10033 ●
- Applicant: IMFOU CO., LTD ●
- Trade Name: FEEL-DRCS ●
- Classification Name: Medical image management and processing system ●
- Classification Panel: Radiology ●
- Classification Regulation: 21 CFR 892.2050
- Product Code: LLZ ●
- Device Class: ●
4
4.2 Reference predicate device
- 510(k) Number: K152172 ●
- Applicant: DRTECH Corporation ●
- Trade Name: EConsole 1 ●
- Classification Name: Medical image management and processing system .
- Classification Panel: Radiology ●
- Classification Regulation: 21 CFR 892.2050 ●
- Product Code: LLZ ●
- Device Class: . II
5. Description of the Device [21 CFR 807.92(a) (4)]
Radiological Image Processing Software, EConsolel is complete digital image processing console software specialized for the digital X-ray detector series developed by DRTECH Corporation.
EConsole1 not only processes the acquired images but also complies with DICOM standards which allow the user 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)]
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).
The main features of this software are controlling and interfacing the detector, controlling the x-ray generator acquisition settings, storing acquired images, data management and image processing.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
EConsole1 is medical software. It digitalizes the signal sent from the detector and displays the x-ray image. Also, it can enter patient information, shot information, and other necessary references for convenience.
Compared with the predicate device, the technological characteristics of the proposed device, Econsole1, are substantially equivalent to those of the proposed device is functionally similar to the predicate device.
Additionally, our device does not exert control over generator power that produces ionizing radiation. The control function of the X-ray generator is dependent on the specific X-ray Generator company, as EConsole1 can only interface and be controlled using the protocol provided by that particular company. Moreover, EConsole1 can only select or modify values of X-ray exposure parameters (such as kVp, mA, second, or kVp; mAs) according to the defined values set by each X-ray company. However, EConsole1 does not have control over exposure, electrical changes, or the calibration of the X-ray system. Therefore, it is necessary for the radiological technician to check the X-ray exposure conditions on the X-ray Generator before conducting any X-ray procedures. If the X-ray generator does not allow interface with external software, such as EConsole1, the software will not be able to interface with the X-ray Generator.
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| Parameter | Subject Device | Predicate Device | Reference Device | Comparison
Analysis |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 510(k) Number | Unknown | K110033 | K152172 | N/A |
| Model Name | EConsole1 | FEEL-DRCS | EConsole1 | N/A |
| Manufacturer | DRTECH Corporation | IMFOU CO., LTD | DRTECH Corporation | N/A |
| Common Name | Radiological
Image
Processing System | Radiological
Image
Processing System | Radiological
Image
Processing System | Identical |
| Classification
Name | Medical
image
management
and
processing system | Medical
image
management
and
processing system | Medical
image
management
and
processing system | Identical |
| Classification
Panel | Radiology | Radiology | Radiology | Identical |
| Classification
Regulation | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Identical |
| Product Code | LLZ | LLZ | LLZ | Identical |
| Device Class | Class II | Class II | Class II | Identical |
| Intended Use | 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).
The main features of
this software are
controlling and
interfacing the
detector, controlling
the x-ray generator
acquisition settings,
storing acquired
images, data
management and
image processing | feel-DRCS software
using a digital X-ray
detector is the digital X-
ray image processing
system designed to
acquire images and
process acquired images
efficiently.
The main features of this
software are controlling
and interfacing the
detector, acquiring
images after X-ray,
storing acquired images,
managing data,
optimizing window level
and width of acquired
images, rotating images,
zooming images,
measuring images and so
on.
feel-DRCS is compatible
with DICOM 3.0
standard. It can transfer
images processed in
PACS and print images
with a film printer. | The Econsole1
software is indicated
for use in general
radiographic images
of human anatomy
(excluding
fluoroscopic,
angiographic, and
mammographic
applications). | Identical |
| Acquisition devices | Digital X-ray Detector | Digital X-ray Detector | compatible with DICOM 3.0 by using DICOM and network systems.
feel-DRCS is not approved for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.
feel-DRCS is not approved for the acquisition of mammographic image data. | Identical |
| Software Function | Image viewing
Image search
Image storage
Image annotation
Image measurement
Image processing
Image stitch
Generator Control | Image viewing
Image search
Image storage
Image annotation
Image measurement
Image processing
Image stitch
Generator Control | Image viewing
Image search
Image storage
Image annotation
Image measurement
Image processing
Image stitch | Identical |
| DICOM Compliance | Yes | Yes | Yes | Identical |
8. Substantial Equivalence Comparison [21 CFR 807.92(b)]
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When compared to the predicate devices (K110033), the device presented in this submission, EConsole1, has the same of the followings as the predicate device:
- Intended Use
- Performance properties
- Technological characteristics
- Software function
There are no significant differences between the EConsole1 and the predicate device that would have a negative impact on the product's use. Therefore, the subject device is considered substantially equivalent to the predicate device.
7
9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
The EConsole1 complies with the following international and FDA-recognized consensus standards:
| 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 | |||
| 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 |
Software Verification and Validation
As part of this submission, the Software Documentation for a Medical Device with Moderate Level of Concern, as outlined in the FDA's Guidance Document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005, is also provided.
The data indicates that medical devices containing software adhere to special controls consistently. During the product development of EConsole1, various non-clinical tests such as code, module, integration, and dynamic tests were conducted. A risk analysis was carried out, and risk controls were put in place to mitigate identified hazards. The test results suggest that all software specifications meet the acceptance criteria. Furthermore, the verification and validation testing were deemed acceptable, thereby supporting the claim of substantial equivalence.
Cybersecurity
EConsole1 conforms to Section 6 of the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff (October 2, 2014), to maintain confidentiality, integrity, and availability. Additionally, EConsolel is linked through DICOM standards to medical devices and a PACS system, which stores data generated by the medical devices. It retrieves image data via network communication based on DICOM standards. Therefore EConsole I assures an adequate degree of protection for cybersecurity.
8
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
DRTECH
10. Summary of Clinical Data [21 CFR 807.92(b)(2)]
Clinical studies are unnecessary to validate the safety and effectiveness of the software in EConsole1, the subject of this 510(k) notification.
11. Conclusion [21 CFR 807.92(b)(3)]
EConsole1 is substantially equivalent to the predicate device. It has the same intended use, performance properties and technological characteristics as its predicate device.
EConsole1 passed all Verification and Validation testing, which means that the features, functions and technology were all demonstrated to perform well. Performance data also demonstrates that EConsole1 is both safe and effective in its intended performance.
Therefore, EConsole1 does not introduce any new potential safety risks and is substantially equivalent to the predicate device.