(132 days)
No
The summary describes standard digital radiography console software functionalities like image acquisition, processing, DICOM compliance, and PACS integration, without mentioning AI, ML, or related concepts.
No
The device is described as software that acquires and processes X-ray images, implying it is used for diagnostic purposes rather than for treating a disease or condition.
No
The device is described as operating console software for X-ray projection that acquires and processes images. While it handles medical images, its primary function is image acquisition, processing, and transmission within an imaging workflow, not the interpretation or diagnosis of medical conditions.
Yes
The device description explicitly states "Econsole1 is digital radiography operating console software" and describes its functions as software-based (acquiring, processing, transmitting, receiving, printing data). While it integrates with a digital detector, the device itself is presented as the software component.
Based on the provided information, the Econsole1 software 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, tissue) to provide information about a person's health.
- Econsole1's Function: The description clearly states that Econsole1 is "digital radiography operating console software" that "acquires and processes images" from a "Digital X-ray Detector" of "human anatomy". It deals with in vivo imaging (imaging within the living body), not in vitro analysis of specimens.
The software's purpose is to manage and process radiographic images obtained directly from a patient, not to analyze biological samples.
N/A
Intended Use / Indications for Use
The Econsole1 software is indicated for use in general radiographic images of human anatomy (excluding fluoroscopic, angiographic, and mammographic applications).
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
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
This section is not applicable
Key Metrics
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/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.
1
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
2
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) | |
|---|---|
| ------------------------------------------------- | -- |
X 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
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:
4
5. Description of the Device [21 CFR 807.92(a) (4)]
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.
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 is | |
| indicated for use in general | ||
| radiographic images of human | ||
| anatomy (excluding fluoroscopic, | ||
| angiographic, and | ||
| mammographic applications). | 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 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. | ||
| Acquisition devices | Digital X-ray Detector | Digital X-ray Detector |
| Software Function | Image viewing | |
| Image search | ||
| Image storage | ||
| Image annotation | ||
| Image measurement | ||
| Image processing | ||
| Image stitch | Image viewing | |
| Image search | ||
| Image storage | ||
| Image annotation | ||
| Image measurement | ||
| Image processing | ||
| Image stitch | ||
| Generator Control | ||
| DICOM 3.0 Compatibility | Yes | Yes |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
5
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
6
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.