feel-DRCS software, used together with digital X-ray detector is the digital X-ray image processing system designed for acquiring images and processing 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 other features used for imaging processing.

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.

Device Description

This medical imaging device software is composed of a combination of many functions. The functions include interfacing X-ray detector, integration X-ray generator, networking PACS, image enhancement processing and editing image/information. The name of this software is called DROC(Digital Radiography Operation Console)

The operational process of feel-DRCS is described below:

1 Input or select study information patient ID/Name, body part and projection, if you can use DICOM Modality Worklist Management SCP, you select in worklist.
Setup exposure parameter of X-ray generator (2)
After exposure, this software acquires raw images from X-ray Detector. (3)
A After acquisition of raw image, this software corrects raw image.
(5) After correction of raw image, this software processes with noise reduction, enhancement, auto windowing etc.
(6) After processing of corrected image, this software displays an image on the monitor.
(7) If this software is connected with PACS network, it transfers images to PACS Server or DICOM film printer.

AI/ML Overview

The provided text is a 510(k) summary for the feel-DRCS Radiological Image Processing System. This document focuses on establishing substantial equivalence to a predicate device based on intended use and technological characteristics rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria for specific performance metrics (e.g., diagnostic accuracy, sensitivity, specificity).

Therefore, based solely on the provided text, the following information is largely not available or not applicable in the format requested.

The document states: "This section [Summary of non-clinical testing:] is not applicable." This indicates that the submission did not include a specific study to prove the device meets acceptance criteria related to its image processing performance in a quantitative manner. Instead, the equivalence is argued based on functional similarity.

Here's a breakdown of what can be gleaned and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined as quantitative performance metrics in this summary. The acceptance is based on demonstrating substantial equivalence to the predicate device in terms of intended use, technological characteristics, and performance properties.	The device is deemed "substantially equivalent" to the predicate device (K091364 / dicomPACS DX-R 1.6) in all listed characteristics, implying it meets the same functional and operational standards as the predicate.
Specific functional criteria from comparison table:
Acquiring, viewing, editing and storing radiographs and related patients images	Same as predicate
Radiologist as intended user	Same as predicate
Operating system (Windows XP/7)	Meets criteria (predicate allowed XP/Vista/7)
Network (10/100/1000 Ethernet)	Same as predicate
Monitor (Above 19inch, Above 1280x900)	Meets criteria (predicate 19inch, 1280x1024)
User interaction (Mouse, Keyboard, Touch Monitor)	Same as predicate
Multi-user (one user at a time)	Same as predicate
Import / export images	Yes
Acquisition devices (Computed Radiography, Digital X-ray Detector)	Same as predicate
Imaging interfaces (Detector dependent)	Same as predicate
Image organization (Patient ID/Name/Study instance UID)	Same as predicate
Image search available	Yes
Image storage	Yes
Database storage (MS-Access)	Yes (differs from predicate's MS-SQL but still functional)
Image viewing	Yes
Image measurement	Yes
Image annotation	Yes
Image operations	Yes
Security (Priority by User)	Same as predicate
DICOM 3.0 Compatibility	Yes
Generator Control	OK
Generator Control protocol (Generator dependent)	Same as predicate
Raw image data processing	OK
Post image data processing	OK
RIS Code manager	OK

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available. The submission explicitly states, "Summary of non-clinical testing: This section is not applicable." This indicates that no specific test set data was provided to evaluate the performance against specific acceptance criteria for image analysis or diagnostic accuracy. The assessment relies on a comparison of device functionalities and characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Since no specific test set or performance study was conducted to establish diagnostic accuracy or image processing quality against a "ground truth," experts were not used in this capacity for the purpose of the 510(k) submission as described. The intended users of the device are "qualified medical personnel" and "Radiologists."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or performance study was described, so no adjudication method would have been necessary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a "Radiological Image Processing System" intended for basic image processing, viewing, and archival. It is not described as an AI-powered diagnostic aid, and no MRMC study was mentioned or implied.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. The device is a "Picture archiving and communications system" and "Radiological Image Processing System" which inherently involves human interaction for input, processing, and interpretation. No standalone algorithm performance study, in the sense of a diagnostic algorithm, was conducted or reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No performance study requiring a form of ground truth was conducted or reported in this 510(k) summary.

8. The sample size for the training set

Not Applicable. This device is an image processing and archiving system, not a machine learning or AI-driven diagnostic algorithm that typically relies on a distinct training set. The functionality is based on established image processing techniques and DICOM standards.

9. How the ground truth for the training set was established

Not Applicable. As there is no described training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.

Summary

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K110033

SEP 1 5 2011

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Submitter Information: Imfou Co., Ltd #301, 3Fl, EnC Venture Dream Tower 5st, 197-13 Guro 3-dong, Guro-gu, Seoul 152-179, Korea.

Contact Person:

Ho Dong, Yang Onbix Corporation #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, Seoul (135-768) Korea Tel: *82-2-566-3360 / Fax: *82-2-6280-3360 Email: onbix@naver.com

Date Summary Prepared: May 17, 2011

Device Name:

Trade Name(s) :	feel-DRCS
Classification Name :	Picture archiving and communications system.
Common Product Name :	Radiological Image Processing System.
Panel :	Radiology
Product Code:	LLZ

Predicate Device Information:

K091364 / dicomPACS DX-R 1.6

Device Description:

The operational process of feel-DRCS is described below:

1 Input or select study information patient ID/Name, body part and projection, if you can use DICOM Modality Worklist Management SCP, you select in worklist.
Setup exposure parameter of X-ray generator (2)
After exposure, this software acquires raw images from X-ray Detector. (3)
A After acquisition of raw image, this software corrects raw image.

203 (1)

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(5) After correction of raw image, this software processes with noise reduction, enhancement, auto windowing etc.
(6) After processing of corrected image, this software displays an image on the monitor.
(7) If this software is connected with PACS network, it transfers images to PACS Server or DICOM film printer.

Intended Use:

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.

Comparison to Predicate Device(s):

This device is equivalent to the predicate devices in its intended use and technological characteristics, including:

- indications for use
- technological characteristics .
- performance properties

Product name	Predicate device (K091364)dicomPACS DX-R 1.6	New devicefeel-DRCS
Intended use	Acquiring, viewing, editing and storing radiographs and related patients images	same
Intended user	Radiologist	Radiologist
Operating system	Microsoft Windows XP/Vista/7	Microsoft Windows XP/7
Network	10/100/1000 Ethernet	10/100/1000 Ethernet
Monitor	19 inch Monitor(1280 X 1024, etc)	Above 19inch Monitor(Above 1280 X900)
User interaction / input	Mouse, Keyboard, Touch Monitor,	Mouse, Keyboard, Touch Monitor,
Multi-user	AvailableBut at a time, only one user can useit.	AvailableBut at a time, only one user can use it.
Import / export images	Yes	Yes
Acquisition devices	Computed RadiographyDigital X-ray Detector	Computed RadiographyDigital X-ray Detector

003 (2)

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Product name	Predicate device (K091364)dicomPACS DX-R 1.6	New devicefeel-DRCS
Imaging interfaces	Detector dependent	Detector dependent
Image organization	Yes	Yes
	Patient ID/Name/Study instance UID	Patient ID/Name/Study instance UID
Image search available	Yes	Yes
Image storage	Yes	Yes
Database storage	Yes	Yes
Database software	MS-SQL	MS-Access
Image viewing	Yes	Yes
Image measurement	Yes	Yes
Image annotation	Yes	Yes.
Image operations	Yes	Yes
security	Yes(Priority by User)	Yes(Priority by User)
DICOM 3.0 Compatibility	Yes	Yes
Generator Control	OK	OK
Generator Control protocol	Generator dependent	Generator dependent
Raw image data processing	OK	OK
Post image data processing	OK	OK
RIS Code manager	OK	OK

Summary of non-clinical testing:

This section is not applicable.

Conclusion

-- |

: :

ン・・ : 一

Based on the information provided in this summary we conclude that this device is substantially equivalent to the predicate device K091364.

003 (3)

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.

Public Health Service

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

Imfou Co., Ltd. % Mr. Ho Dong Yang Cito Onbix Corporation #821 Smail Plaza, 837-26 Yeujsam-dong Gangnam-gu, Seoul (135-768) REPUBLIC OF KOREA

Re: KI10033

Trade/Device Name: Radiological Image Processing System/feel-DRCS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 8, 2011 Received: August 12, 2011

Dear Mr. Ho Dong Yang:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a logally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

ff you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (01) 796 5450. 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 Small Manufacturers, International and Consumer Assistance at its tollit the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 110033
Device Name: Radiological Image Processing System / feel-DRCS
Indications for Use:

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.

Image /page/5/Figure/7 description: The image shows a diagram of a medical imaging system. The system includes a PACS server, a personal computer, a detector, and detector application software. The personal computer is running software called "feel-DRCS" which performs the following functions: Get DICOM worklist by network, Image acquisition, Image Processing, Image store, and DICOM Sending by network.

Following is the diagram of feel-DRCS software system.

The main functions of feel-DRCS as follows:

A. Acquisition and storage of digital X-ray images from a digital X-ray Detector.
B. Input Study information (patient information, exam information).
C. Management of DataBase of stored (archived) images.

Page 1 of _2

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D. Image processing for enhancement of archived images.
E. Review of stored images.
F. Edit of image(Shutter or crop, insert Marker("L", "R"), Window width/level etc)
G. DICOM Functions(DICOM Storage, DiCOM Worklist, DICOM Print, etc)
H. In case of DR full system(X-ray machine and generator and Digital X-ray detector and etc) or need a interface with installed X-ray System in the feel-DRCS.
- (1) Ability to configure X-ray exposure condition (kVp, mA, Sec etc) for various body parts and positions.
- (2) Communication between Generator Console and feel-DRCS.

This X-ray generator control function depends on the X-ray Generator company. Because feel-DRCS can only interface and control by the algorithm provided by the X-ray Company. And feel-DRCS can only select or change values of X-ray exposure parameters(kVp, mA, Second or kVp; mAs) according to defined value of each X-ray company. The feel-DRCS doesn't control exposure and electrical change and calibration X-ray. So, before exposure of Xray, radiological technician should check the X-ray exposure conditions in the console of X-ray Generator.
If the X-ray generator doesn't allow interface with external software(ex. Feel-DRCS), the software cannot interface with X-ray Generator.

Users

A. For acquisition of Digital X-ray image by Digital X-ray Detector.
B. For development or Production of Digital Radiography Retrofit system on the conventional X-ray system.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patel

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number	K110033
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Page 2 of 2

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).