The Econsole1 software is indicated for use in general radiographic images of human anatomy (excluding fluoroscopic, angiographic, and mammographic applications).

Device Description

Econsole1 is digital radiography operating console software. Econsole1 provides an integrated solution for X-ray projection. It integrates with the digital detector. Furthermore, Econsole1 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

The provided text is a 510(k) Summary for the Econsole1 device. It contains some information about the device's characteristics and comparison to a predicate device, but it does not contain acceptance criteria for performance, nor does it describe a study that proves the device meets such criteria.

The document explicitly states: "10. Summary of Clinical Data. This section is not applicable." This strongly indicates that no clinical study was performed for this 510(k) submission to demonstrate performance against specific criteria in a real-world or simulated clinical setting.

The "Summary of Non-Clinical Data" mentions compliance with a "FDA guidance document entitled 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,' May 11, 2005". This guidance focuses on software development and validation processes, not on demonstrating device performance against clinical or technical acceptance criteria.

The information provided confirms that this device is a "Picture archiving and communications system" and "Radiological Image Processing System" which acquires and processes images. The comparison table focuses on technological equivalence to the predicate device, not on quantitative performance metrics.

Therefore,Based on the provided text, I cannot provide the requested information.

Here's why:

No Acceptance Criteria or Performance Data: The document does not list any specific performance acceptance criteria for the Econsole1 device (e.g., image quality metrics, processing speed metrics, accuracy scores for any automated features). Consequently, there is no reported device performance against such criteria.
No Study Described: The document explicitly states "10. Summary of Clinical Data. This section is not applicable." This means no clinical study (or any study to demonstrate performance against acceptance criteria) was conducted and detailed in this submission. The submission relies on demonstrating substantial equivalence to a predicate device based on intended use and technological characteristics, not on a new performance study.
No Clinical Ground Truth: Since no performance study was conducted, there's no mention of ground truth establishment, expert adjudication, or human reader performance.
No Training Set Information: As no new algorithm performance study is described, there is no information about a training set.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence based on intended use and technological characteristics compared to a predicate device, rather than on presenting performance data against specific acceptance criteria from a new study.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 14, 2015

DRTECH Corporation % Mr. Choul-Woo Shin Vice President Suite No. 2, 3 Floor, 29, Dunchon-daero541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do 462-807 REPUBLIC OF KOREA

Re: K152172

Trade/Device Name: EConsole1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 21, 2015 Received: November 4, 2015

Dear Mr. Shin:

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 (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. 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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ocks

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152172

Device Name Econsole1

Indications for Use (Describe)

The Econsolel software is indicated for use in general radiographic images of human anatomy (excluding fluoroscopic, angiographic, and mammographic applications).

Type of Use (Select one or both, as applicable)
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X 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)] 07/31/2015

2. Submitter's Information [21 CFR 807.92(a) (1)]

Name of Sponsor:	DRTECH Corporation.
Address:	Suit No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil,
	Jungwon-gu, Seongnam-si, Gyeonggi-do 462-807
	Republic of Korea
Contact Name:	Choul-Woo Shin
Telephone #:	+82-31-784-8856
Fax #:	+82-31-784-8899
Email:	cwshin@drtech.co.kr
Registration Number:	3005172103
Name of Manufacturer:	Same as Sponsor

3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

Model Name:	Econsole1
Common Name:	Radiological Image Processing System
Classification Name:	Picture archiving and communications system
Classification Panel:	Radiology
Classification Regulation:	21 CFR 892.2050
Product Code:	LLZ
Device Class:	2

4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

510(k) Number: K110033 Product Code: LLZ Applicant: IMFOU CO., LTD FEEL-DRCS Model Name: Decision Date: 09/15/2011 Traditional Type:

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5. Description of the Device [21 CFR 807.92(a) (4)]

6. Intended Use [21 CFR 807.92(a) (5)]

The Econsole1 software is indicated for use in general radiographic images of human anatomy (excluding fluoroscopic, angiographic, and mammographic applications).

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 predicate device. The proposed device is functionally similar to the predicate device.

Parameter	Subject Device	Predicate Device
510(k) Number	Unknown	K110033
Model Name	Econsole1	FEEL-DRCS
Manufacturer	DRTECH Corporation	IMFOU CO., LTD
Common Name	Radiological Image Processing System
Classification Name	Picture archiving and communications system
Classification Panel	Radiology
Classification Regulation	21 CFR 892.2050
Product Code	LLZ
Device Class	Class II
Intended Use	The Econsole1 software isindicated for use in generalradiographic images of humananatomy (excluding fluoroscopic,angiographic, andmammographic applications).	feel-DRCS software using adigital X-ray detector is thedigital X-ray image processingsystem designed to acquireimages and process acquiredimages efficiently.
		The main features of thissoftware are controlling andinterfacing the detector, acquiringimages after X-ray, storingacquired images, managing data,optimizing window level andwidth of acquired images,rotating images, zooming images,measuring images and so on.feel-DRCS is compatible withDICOM 3.0 standard. It cantransfer images processed inPACS and print images with afilm printer compatible withDICOM 3.0 by using DICOMand network systems.feel-DRCS is not approved forthe acquisition of mammographicimage data and is meant to beused by qualified medicalpersonnel only. All users must bequalified to create and diagnoseradiological image data.feel-DRCS is not approved forthe acquisition of mammographicimage data.
Acquisition devices	Digital X-ray Detector	Digital X-ray Detector
Software Function	Image viewingImage searchImage storageImage annotationImage measurementImage processingImage stitch	Image viewingImage searchImage storageImage annotationImage measurementImage processingImage stitchGenerator Control
DICOM 3.0 Compatibility	Yes	Yes

8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

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9. Summary of Non-Clinical Data

Econsole1 complies with the FDA guidance document entitled 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,' May 11, 2005

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10. Summary of Clinical Data

This section is not applicable

11. Conclusion [21 CFR 807.92(b) (3)]

When compared to the predicate devices (K110033), the Econsole1 presented in this submission has the same of the followings:

Intended Use
Technological characteristics
Performance properties

The two devices share the difference performance as the following:

Generator Control
The predicate device has a generator control feature, but Econso11 does not include such feature. However, such feature does not make a big difference in fulfilling the intended use, which is acquiring images after X-ray and processing the images. Therefore, Econsole1 is substantially equivalent to the predicate device.

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).