ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO

K091918 · Genoray Co., Ltd. · OWB · Oct 7, 2009 · Radiology

Device Facts

• Record ID: K091918
• Device Name: ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
• Applicant: Genoray Co., Ltd.
• Product Code: OWB · Radiology
• Decision Date: Oct 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

ZEN-2090 Pro is a mobile digital C-arm designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, orthopedic, neurologic, stone localization, critical care and emergency room procedures i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the operating room.

Device Story

The ZEN-2090 Pro is a mobile digital C-arm system used for real-time fluoroscopic and radiographic imaging. It consists of a high-frequency inverter generator, a stationary X-ray tube, an XTV camera (CCD type), and a Toshiba image intensifier. The system converts X-radiation patterns into visible images through electronic amplification. It features a 16-frame memory for image storage. The device is operated by clinicians in surgical, diagnostic, and interventional settings, including operating rooms, critical care units, and emergency departments. The output is displayed for the physician to provide guidance during procedures such as orthopedic surgery, endoscopy, and stone localization, facilitating real-time anatomical visualization to assist in clinical decision-making and procedural accuracy.

Clinical Evidence

Bench and clinical evaluation were performed. No specific clinical trial metrics (e.g., sensitivity, specificity) are provided in the summary; the document states that the results of these evaluations indicate the device is as safe and effective as the predicate devices.

Technological Characteristics

Mobile digital C-arm; high-frequency inverter generator; stationary X-ray tube; CCD-type TV camera; Toshiba E5830SD-P4A image intensifier; 16-frame memory; 40-110 kV range; ABC (Automatic Brightness Control) system; mechanical movements include 120-degree orbital rotation, 180-degree rotation, 200mm horizontal travel, 400mm vertical travel, and ±12.5-degree panning.

Indications for Use

Indicated for patients requiring fluoroscopic and radiographic imaging during diagnostic, surgical, and interventional procedures, including cholangiography, endoscopy, orthopedic, neurologic, stone localization, critical care, and emergency room applications.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• GE OEC Fluorostar (K043076)
• Philips BV Endura (K010435)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "GENORAY" in a bold, sans-serif font. To the left of the word are three circular shapes of varying sizes, arranged vertically. The largest circle is at the top, and the smallest is at the bottom.

K091918

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Exhibit 5 510(k) Summary

Fluoroscopic X-Ray System / Modcl: ZEN-2090 Pro

| | 1. | Submitter and US Official Correspondent | | | |
|--|----|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------|--|
| | | Submitter: | GENORAY Co., Ltd. | OCT - 7 2009 | |
| | | Address: | #512, Byucksan Technopia<br>434-6, Sangdaewon-1-dong,<br>Jungwon-gu, Seongnam-city<br>Gyeonggi-do, 462-716, Korea | | |
| | | Telephone No.: | [phone] | | |
| | | Fax: | [phone] | | |
| | | Official Correspondent (U.S):Shin Kuk Yoo, Consultant | | | |
| | | Telephone No.: | 714-313-7442 | | |
| | | Fax No.: | 801-303-7455 | | |
| | | Email: | [e-mail] | | |
| | 2. | Establishment Registration Number | | | |
| | | | 3005843418 | | |
| | 3. | Device Information | | | |
| | | Proprietary/Trade Name: | Fluoroscopic X-Ray System (Model: ZEN-2090 Pro) | | |
| | | Common/Usual Name: | Fluoroscopic X-Ray System | | |
| | | Classification Name: | Image-Intensified Fluoroscopic X-Ray System | | |
| | | Product Code: | JAA | | |
| | | Device Class: | Class II per regulation 21 CFR 892.1650 | | |
| | 4. | Equivalent Legally Marketed Device | | | |
| | | <GE OEC Fluorostar> | | | |
| | | Manufacturer: | GE OEC Medical Systems, Inc. | | |
| | | Device Name: | GE OEC Fluorostar | | |
| | | 510(k) Number: | K043076 (Decision Date - Dec. 22, 2004) | | |
| | | Classification: | Image-Intensified Fluoroscopic X-Ray System: JAA, Class II per | | |

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GENORAY Co., Ltd.

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# <Philips BV Endura>

| Manufacturer: | Philips Mcdical Systems North America Company |
|-----------------|-------------------------------------------------------------------------------------------|
| Device Name: | Philips BV Endura |
| 510(k) Number: | K010435 (Decision Date - Mar. 12, 2001) |
| Classification: | Image-Intensified Fluoroscopic X-Ray System: JAA, Class II per regulation 21 CFR 892.1650 |

## Deseription of the Device

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ZEN-2090 Pro is consisted of the X-ray tube, X-ray tube assembly, x-ray controller, XTV camera and some accessories.

The ZEN-2090 Pro is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

| Product | ZEN-2090 Pro |
|-------------------|-------------------------------------------------------|
| Items | |
| Generator | High Frequency Inverter |
| X-ray tube | Stationary tube |
| Fluoroscopy | 40~110 kV / 0.2~6mA<br>Boost mode:10mA<br>ABC control |
| Radiography | 40~ 110 kV/20mA |
| TV Camera | CCD Type |
| Frame Memory | 16 Frame |
| Image Intensifier | E5830SD-P4A of Toshiba |
| Panning motion | ±12.5° |
| Parallel motion | N/A |
| Orbit. Rotation | 120 Degrees |
| Horiz. Travel | 200mm |
| Vert. Travel | 400mm |
| Rotation | 180 Degrees about |
| Panning motion | ±12.5° |
| Parallel motion | N/A |

# GENORAY Co., Ltd.

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CONFIDENTIAL

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#### 6. Indications for use

.

ZEN-2090 Pro is a mobile digital C-arm designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, orthopedic, stone localization, critical care and emergency room procedures

i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the operating room.

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

The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.

## GENORAY Co., Ltd.

## CONFIDENTIAL

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the design.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

GENORAY Co., Ltd. % Mr. Shin Kuk Yoo Consultant Manager LSK BioPartners, Inc. 215 South State Street, Suite 100B SALT LAKE CITY UT 84111

Re: K091918

Trade/Device Name: Fluoroscopic X-Ray System (Models: ZEN-2090 Pro) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO, and JAA Dated: September 4, 2009 Received: October 1, 2009

MAY 16 2012

Dear Mr. Yoo:

This letter corrects our substantially equivalent letter of October 7, 2009.

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, Dr 0
and Court of the recomment with the provisions of the Federal Food, Dr 0 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 2017 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 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 number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting 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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Exhibit 4

Indications for Use

510(k) number (if known):

Device Name: Fluoroscopic X-Ray System (Models: ZEN-2090 Pro) Indications for Use:

AND/OR

ZEN-2090 Pro is a mobile digital C-arm-designed-to-provide-finoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, orthopedic, ncurologic, stone localization, critical care and emergency room procedures

i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the operating room.

Prescription Use > (Part 21 CFR 801 Subpart D)

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)

on Sign-Off) (Divis Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

GENORAY Co., Ltd.

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