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.

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.

AI/ML Overview

This document, a 510(k) summary, lacks the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study proving the device meets them. Specifically, it does not contain the specifics of a study conducted to prove the device's performance against acceptance criteria for an AI/CAD/software-as-a-medical-device (SaMD) product.

The EConsole2 is described as a Radiological Image Processing System (software), which "acquires and processes images" and "can utilize and transfer the digitalizing x-ray images for radiography diagnostic." However, the summary focuses on its equivalence to a predicate device (EConsole1) primarily based on shared software functions, DICOM compliance, and safety standards adherence.

The key statement regarding performance is: "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." However, it does not provide the details of these "test results" or "acceptance criteria" in the context of diagnostic performance as would be expected for an AI-powered image analysis device.

The document explicitly states: "Clinical studies are unnecessary to validate the safety and effectiveness of the Radiological Image Processing System, EConsole2, the subject of this 510(k) notification." This strongly suggests that an MRMC or standalone performance study measuring diagnostic accuracy (e.g., sensitivity, specificity, AUC) was not performed or submitted as part of this 510(k) given their determination that clinical data was "unnecessary."

The "ECE Function" is mentioned as a new "optional" image processing feature that "normalizes the image brightness and contrast regardless of the exposed x-ray dose." While this is a form of image processing, the summary doesn't describe it as an AI/CAD function with specific performance metrics against an established ground truth for diagnostic purposes.

Therefore, I cannot provide the requested information about acceptance criteria, detailed study results, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/CAD device's diagnostic performance. The 510(k) appears to be based on substantial equivalence for a medical image management and processing system rather than demonstrating the performance of a novel AI-driven diagnostic aid.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K240243

Device Name EConsole2

Indications for Use (Describe)

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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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 ●

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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)]

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.

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DRTECH

8. Substantial Equivalence Comparison [21 CFR 807.92(b)]

Parameter	Proposed Device	Predicate Device	EquivalenceAnalysis
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
ClassificationRegulation	21 CFR 892.2050	21 CFR 892.2050	Equivalence
Product Code	LLZ	LLZ	Equivalence
Device Class	Class II	Class II	Equivalence

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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 radiographicimages of human anatomy. It is intended to replaceradiographic film/screen systems in all general-purpose diagnostic procedures (excludingfluoroscopic, angiographic, and mammographicapplications). It is intended for both adult andpediatric populations.	EConsole1 is indicated for use in generalradiographic images of human anatomy. It isintended to replace radiographic film/screensystems in all general-purpose diagnosticprocedures (excluding fluoroscopic, angiographic,and mammographic applications).	Similar
Software Function	Image acquisition and studyImage searchImage storageImage annotationImage measurementImage stitchImage processingGenerator Control	Image acquisition and studyImage searchImage storageImage annotationImage measurementImage stitchImage processingGenerator Control	Similar
DICOM Compliance	Yes	Yes	Equivalence
Software Function		Technological characteristics		EquivalenceAnalysis
		Proposed Device(Non)	Predicate Device(K231225)
Generator Control		This function controls the generator to set X-rayirradiation conditions(such as kVp, mA, mAs, etc.) canbe adjusted. And this function transmit the set data to thegenerator. Then It is displayed the set X-ray irradiationconditions, and displays the image acquired after X-rayirradiation.	This function controls the generator to set X-rayirradiation conditions(such as kVp, mA, mAs, etc.)can be adjusted. And this function transmit the setdata to the generator. Then It is displayed the setX-ray irradiation conditions, and displays theimage acquired after X-ray irradiation.	Equivalence
		But this control function of EConsole2 does not exertscontrol over generator power that produces ionizingradiation. However, Its does not have control overexposure, electrical changes, or the calibration of the X-ray system.	But this control function of EConsole2 does notexerts control over generator power that producesionizing radiation. However, Its does not havecontrol over exposure, electrical changes, or thecalibration of the X-ray system.	Equivalence
DEXi Function		1. When generator which supports DEXi and whenexamining DEXi, mark the irradiation condition(HighkV, 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 withgenerator and control the irradiation condition.	1. When generator which supports DEXi and whenexamining DEXi, mark the irradiationcondition(High kV, High mA, High mAs, Low kV,Low mA, Low mAs) and provide button to controlthe irradiation condition.2. When changing the irradiation condition,connect with generator and control the irradiationcondition.	Equivalence
	Truveiw ART	Increase the sharpness of the obtained x-ray images.	Increase the sharpness of the obtained x-rayimages.	Equivalence
ImageProcessing(Optional)	ECE Function	ECE function can be applied before the main imageprocessing. This function normalizes the imagebrightness and contrast regardless of the exposed x-raydose.ECE function works as a simple linear transformation toeach pixel value.To find the slope and the offset of the linear function,ECE function first finds two or more reference points inthe radiograph. The reference points are selecteddepending on the body part and position of the patient.By using these reference points, we can determine the	N/A	This is newfunction ofEConsole2.

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

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DRTECH

In case of Technological characteristics, all items are the same, but some items have detailed optional functions. Please refer to the below table.

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DRTECH

slope and the offset of the linear function.Finally, by using the inverse of the linear function, thebrightness and the contrast of the radiograph will benormalized even with different x-ray exposure condition.And now some desired function, such as gammacorrection or LUT, can be applied.With ECE function, the main image processing enginecan expect an image with similar brightness and contrastregardless of the x-ray exposure condition. Therefore, theresulting radiograph will have more uniform imagequality.The user cannot change the parameters of this function orturn it off. Only the engineers can change. And thisfunction is used for all of the body parts including chest,abdomen, pelvis, skull, extremities and etc.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--	--

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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
13-79	IEC 62304 Edition 1.1 2015-06CONSOLIDATED VERSION	Medical device software - Softwarelife cycle processes
13-129	ISO IEC IEEE 29119-1 Firstedition 2013-09-01	Software and systems engineering -Software testing - Part 1: Conceptsand definitions
12-349	NEMA PS 3.1 - 3.20 2022d	Digital Imaging andCommunications in Medicine(DICOM) Set
5-135	ISO 20417 First edition 2021-04Corrected version 2021-12	Medical devices - Information to besupplied by the manufacturer
5-129	IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATEDVERSION	Medical devices - Part 1:Application of usabilityengineering to med
5-125	ISO 14971 Third Edition 2019-12	Medical devices - Application ofrisk management to medical device
13-96	UL ANSI 2900-1 First Edition2017	Standard for Safety, Standard forSoftware 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 forIndustry and Food and Drug Administration Staff	June 14, 2023
Off-The-Shelf Software Use in Medical Devices	August 11, 2023

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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 ofPremarket 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.

Regulation Number and Section

§ 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).