ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

K103181 · Genoray Co., Ltd. · LLZ · Aug 26, 2011 · Radiology

Device Facts

• Record ID: K103181
• Device Name: ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Applicant: Genoray Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Zenis is intended for viewing of images acquired from Fluoroscopic X-ray system when installed on suitable commercial-standard PC hardware. Zenis is intended for use as a primary diagnostic and analysis workstation in Radiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.

Device Story

Zenis is a PC-based DICOM workstation platform for medical imaging management; accepts, transmits, prints, displays, stores, edits, and digitally processes medical images and associated data. Operates on commercial-standard PC hardware; connects to PACS networks or directly to imaging modalities via DICOM networking. Used by radiologists and clinicians in healthcare facilities for primary diagnosis, analysis, and clinical review. Output consists of processed medical images displayed on the workstation monitor, facilitating clinical decision-making by providing diagnostic-quality visualization of fluoroscopic X-ray data.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by performance testing and clinical evaluation demonstrating safety and effectiveness comparable to the predicate device.

Technological Characteristics

PC-based software platform; DICOM-compliant; operates on commercial-standard PC hardware; supports image acceptance, transmission, printing, display, storage, editing, and digital processing; network-connected via DICOM protocols.

Indications for Use

Indicated for viewing images from fluoroscopic X-ray systems. Used as a primary diagnostic, analysis, or clinical review workstation in radiology or other healthcare departments.

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

• RA600 (K042525)

Submission Summary (Full Text)

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# Exhibit 5 510(k) Summary

# AUG 26 2011

Picture archiving and communications system / Model: Zenis

- 1. Company and Correspondent making the submission
- 1.1 Submitter and US Official Correspondent

Submitter: GENORAY Co., Ltd. Address: #512, Byucksan Technopia, 434-6, Sangdaewon 1-dong, Jungwon-gu, Seongnam-city, Gyeonggi-do, 462-716 Korea Telephone No.: [phone] Fax: [phone]

- 1.2 Official Correspondent (U.S): Jae Kim Business Manager Correspondent: GENORAY America Inc. 1073 N. Batavia St. Orange, CA 92867, USA Address: Telephone No.: 714-289-8020 Fax: [phone] Email: [e-mail]
- 2. Establishment Registration Number 3005843418
- 3. Device Information

| Proprietary/Trade Name: | Picture archiving and communications system<br>/ Model: Zenis |
|-------------------------|---------------------------------------------------------------|
| Common/Usual Name: | Picture archiving and communications system |
| Classification Name: | System, Image Processing, Radiological |
| Product Code: | LLZ |
| Device Class: | Class II per regulation 21 CFR 892.2050 |

- 4. Equivalent Legally Marketed Device

| Manufacturer: | GE Medical Systems Information Technologies |
|-----------------|-----------------------------------------------------------------------------------------|
| Device Name: | RA600 |
| 510(k) Number: | K042525 (Decision Date - October 1, 2004) |
| Classification: | System, Image Processing, Radiological: LLZ,<br>Class II per regulation 21 CFR 892.2050 |

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# 5. Description of the Device

Zenis is a PC-based DICOM workstation platform which provides scalable image and data management solutions for medical imaging. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data.

Zenis may be combined with a PACS network or connected directly to a modality through the use of DICOM networking.

#### 6. Indications for use

Zenis is intended for viewing of images acquired from Fluoroscopic X-ray system when installed on suitable commercial-standard PC hardware. Zenis is intended for use as a primary diagnostic and analysis workstation in Radiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.

#### 7. Safety and Effectiveness, comparison to Predicate

Zenis, which is made by GENORAY Co., Ltd., is substantially equivalent to RA600 of GE healthcare. We selected the RA600 as the predicate device already FDA approved. Because of RA600 and Zenis are almost same in function & characteristic. Zenis & RA600 are intended for use as PACS software used for viewing of medical images acquired from modality when installed on suitable commercial-standard PC hardware. The result of performance test and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.

### Conclusion 8.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 GENORAY Co., Ltd., concludes that the Picture archiving and communications system (Model: Zenis) is safe and effective and substantially equivalent to the predicate device as described above.

GENORAY Co., Ltd.

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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

Genoray Co., Ltd. % Mr. Jae Kim Business Development Manager Genoray America, Inc. 1073 N. Batavia St. ORANGE CA 92867

ANG 2 5 2011

Re: K103181

Trade/Device Name: Picture archiving and communications system (Models: Zenis) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 15, 2010 Received: July 8, 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, perroits 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 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 toll free miber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S. Patil

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 Exhibit 4

510(k) number (if known): `K|0318|

· Device Name: Picture archiving and communications system (Models: Zenis)

Indications for Use:

Zenis is intended for viewing of images acquired from Fluoroscopic X-ray system when installed on suitable commercial-standard PC hardware. Zenis is intended for use as a primary diagnostic and analysis workstation in Radiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.

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

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*(Division Sign-Off)*

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K103181

CONFIDENTIAL