RADIOLOGICAL IMAGE PROCESSING SYSTEM

K102078 · VATECH Co., Ltd. · LLZ · Aug 10, 2011 · Radiology

Device Facts

• Record ID: K102078
• Device Name: RADIOLOGICAL IMAGE PROCESSING SYSTEM
• Applicant: VATECH Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

XmaruView V1 software is to make the processing and administration of medical X-ray images as efficient as possible. Functions to be carried out using XmaruView V1 is, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements. XmaruView V1 software can control X-ray generator acquisition settings. XmaruView V1 is not approved for the acquisition of mammographic image data and it cannot be used to interpret mammographic image date either. XmaruView V1 is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data. XmaruView V1 is complying with DICOM standards to assure optimum communications between network systems.

Device Story

XmaruView V1 is a radiographic image capture and processing software system. It integrates control of flat-panel detectors and X-ray generators to acquire, process, and manage medical X-ray images. Used in clinical environments by qualified medical personnel to streamline workflow. Features include window leveling, rotation, zoom, and measurement tools. The system includes a database for image/data management and supports DICOM output for integration with PACS. It does not perform mammographic imaging. Healthcare providers use the output for diagnostic purposes; the software facilitates efficient image handling and communication across network systems.

Clinical Evidence

Bench testing only. Compliance with NEMA PS 3.1-3.18 (DICOM), IEC 62304 (software life-cycle), and ISO 14971 (risk management) standards.

Technological Characteristics

Radiological image processing software. Connectivity: DICOM compliant. Software life-cycle: IEC 62304 compliant. Risk management: ISO 14971 compliant. Operates on standard PC hardware (processor/RAM requirements).

Indications for Use

Indicated for processing and administration of medical X-ray images by qualified medical personnel. Not indicated for mammographic image acquisition or interpretation.

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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# 510(k) Summary

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

## Date

July 21, 2010

### Manufacturer

Vatech Co., Ltd.

473-4 Bora-Dong, Giheung-Gu, Yonggin-si, Gyeonggi-do, 446-904, Korea Republic

Tel: [phone] Fax: [phone] Contact person: Ms. Yang-kyong Kim / Compliance Officer Email: [e-mail]

## United States Sales Representative (U.S. Designated agent)

VATECH America. 333 Meadowlands Parkway, #303, Secaucus, NJ, 07094, USA

Tel: [phone] Fax: [phone] Contact person: Mr. Dave Kim

## Trade/Proprietary Name:

XmaruView V1

## Common Name:

Radiological Image Processing System

## Classification Name:

System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class2)

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#### Description:

XmaruView V1 is a radiographic image capture program in charge of variety of image related works, including photographing Digital Radiography, acquiring and processing the images, and the image management.

XmaruView V1 provides integrated controls the flat-panel detector and the Xray generator of a radiographic system to perform image acquisitions and image processing. Its own database storage capability enables a user the convenient management of patient images and data. In addition, it supports DICOM output for a seamless integration with the operating environment where PACS is installed,

XmaruView V1 has been developed to meet the requirements of hospitals to provide a seamless work flow in the heavy work load environment and thus is equipped with a number of relevant convenience functions.

#### Indication for use:

XmaruView VI software is to make the processing and administration of medical X-ray images as efficient as possible. Functions to be carried out using XmaruView V1 is, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements. XmaruView VI software can control X-ray generator acquisition settings. XmaruView V1 is not approved for the acquisition of mammographic image data and it cannot be used to interpret mammographic image date either. XmaruView VI is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data. XmaruView V1 is complying with DICOM standards to assure optimum communications between network systems.

#### Predicate Device:

| Manufacturer | : Oehm und Rehbein GmbH. |
|---------------|------------------------------------------|
| Device | : dicomPACS® DX-R 1.6 |
| 510(k) Number | : K091364 (Decision Date - DEC 11, 2009) |

## Substantial Equivalence:

The XmaruView V1 described in this 510(k) has the same intended use and similar technical

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characteristics as the dicomPACS® DX-R 1.6 of Oehm und Rehbein GmbH.

The model dicomPACS® DX-R is the primary predicate device. The subject device and predicate device are substantially equivalent, having the same/similar indications for use and functionalities like operation software, resolution, X-ray generator control, image processing, windowing, zoom, rotation, DICOM worklist, DICOM store and DICOM print. The differences are cosmetic, arrangement and components use only. Both subject device and dicomPACS® DX-R are categorized in product code LLZ; equivalence between these models is evident,

Differences between the subject device and predicate device include processor, RAM requirement, networking and image format size. These differences do not raise any new questions of safety or effectiveness.

## Safety and Performance Data:

- NEMA PS 3.1-3.18 Digital Imaging and Communications in Medicine (DICOM) set (2008)

- IEC 62304 Medical device software – Software life-cycle processes : 2006

- ISO 14971 Medical Devices – Application of risk management to medical device : 2007

### Conclusion:

None of the modifications alter the Indications for Use in a significant way, nor the fundamental scientific technology, and do not introduce a fundamentally new scientific technology. Therefore, it is our opinion that the XmaruView V1 described in this submission is substantially equivalent to the predicate device.

END

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Public Health Service

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

VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Consultant VATECH America 333 Medowlands Parkway #303 SECAUCUS NJ 07094

AUG 1 0 2011

Re: K102078

Trade/Device Name: Radiological Image Processing System/XmaruView V1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 9. 2011 Received: May 17, 2011

Dear Mr. Kim:

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 (21 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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro 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 Biometries/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 toll-free number [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): K102078

Device Name: Radiological Image Processing System /XmaruView V1

Indications for Use:

XmaruView V1 software is to make the processing and administration of medical X-ray images as efficient as possible. Functions to be carried out using XmaruView V1 is, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements. XmaruView V1 software can control X-ray generator acquisition settings. XmaruView V1 is not approved for the acquisition of mammographic image data and it cannot be used to interpret mammographic image date either. XmaruView V1 is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data. XmaruView V1 is complying with DICOM standards to assure optimum communications between network systems.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation(ODE)

Mary Patel

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Office of In Viti

510K K102628