FEEL-DRCS

K110033 · Imfou Co., Ltd. · LLZ · Sep 15, 2011 · Radiology

Device Facts

• Record ID: K110033
• Device Name: FEEL-DRCS
• Applicant: Imfou Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Sep 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 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.

Device Story

Software-based radiological image processing system (DROC); interfaces with digital X-ray detectors and generators. Inputs: patient study info (manual or DICOM worklist), raw image data from detector. Processing: raw image correction, noise reduction, enhancement, auto-windowing. Outputs: processed images displayed on monitor, transferred to PACS/DICOM printers. Used in clinical settings by radiologists/technicians. Enables image editing (crop, markers, window/level), measurement, and X-ray exposure parameter configuration (kVp, mA, sec) via generator interface. Benefits: efficient image acquisition, standardized DICOM workflow, improved image visualization for diagnosis.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Software-based image processing system; runs on Windows XP/7. Connectivity: DICOM 3.0, 10/100/1000 Ethernet. Database: MS-Access. Interfaces: Digital X-ray detectors and X-ray generators (protocol-dependent). Features: image enhancement, noise reduction, auto-windowing, measurement, annotation, DICOM storage/print/worklist. Standalone software application.

Indications for Use

Indicated for qualified medical personnel to acquire, process, store, and manage digital X-ray images. Not for mammographic image data. Users must be qualified to create and diagnose radiological image data.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• dicomPACS DX-R 1.6 (K091364)

Submission Summary (Full Text)

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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: [e-mail]

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:

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.

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 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.

#### 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)<br>dicomPACS DX-R 1.6 | New device<br>feel-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 X<br>900) |
| User interaction / input | Mouse, Keyboard, Touch Monitor, | Mouse, Keyboard, Touch Monitor, |
| Multi-user | Available<br>But at a time, only one user can use<br>it. | Available<br>But at a time, only one user can use it. |
| Import / export images | Yes | Yes |
| Acquisition devices | Computed Radiography<br>Digital X-ray Detector | Computed Radiography<br>Digital X-ray Detector |

003 (2)

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| Product name | Predicate device (K091364)<br>dicomPACS DX-R 1.6 | New device<br>feel-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

-- |

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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 [phone]. 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 [phone] or [phone] 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 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.

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.

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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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