ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM

K103425 · Genoray America, Inc. · OWB · Mar 29, 2011 · Radiology

Device Facts

• Record ID: K103425
• Device Name: ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
• Applicant: Genoray America, Inc.
• Product Code: OWB · Radiology
• Decision Date: Mar 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

ZEN-7000 Digital mobile Imaging system is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Device Story

Mobile fluoroscopic X-ray system; consists of mainframe C-arm and mobile workstation. Mainframe includes high-frequency inverter generator, X-ray tube, and image intensifier; performs linear and rotational motions for patient positioning. Workstation supports image display monitors and recording devices. Used in clinical settings (OR, ER, etc.) by physicians for real-time imaging during diagnostic, surgical, and interventional procedures. Provides fluoroscopic and spot-film images to assist clinical decision-making; enables visualization of internal structures for orthopedic, vascular, cardiac, and other procedures.

Clinical Evidence

Bench and clinical evaluation performed. Results indicate the device is as safe and effective as the predicate device.

Technological Characteristics

Mobile C-arm fluoroscopic system; high-frequency inverter generator (5 kW max output); rotating X-ray tube; 9-inch image intensifier (9"/6"/4.5"); CCD-type TV camera. Fluoroscopy range 40-120 kV/0.2-6.0 mA; Radiography range 40-120 kV/20 mA. Mechanical motions: ±12.5° wig wag, 135° orbital rotation, 200 mm horizontal travel, 450 mm vertical travel.

Indications for Use

Indicated for patients requiring fluoroscopic and spot-film imaging during diagnostic, surgical, and interventional procedures, including cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, 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

• OEC 9800 Plus (K021049)

Submission Summary (Full Text)

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### 510(k) Summary Exhibit 5

Fluoroscopic X-Ray System / Model: ZEN-7000

- Company and Correspondent making the submission: 1.

| 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. |
|-----------------|-------------------------------------------|
| Address: | 1073 N. Batavia St. Orange, CA 92867, USA |
| Telephone No .: | 714-289-8020 |
| Fax: | 714-453-9661 |
| Email: | jae@genorayamérica.com |

- Establishment Registration Number 2. 3005843418
#### 3. Device Information

| Proprietary/Trade Name: | Fluoroscopic X-Ray System<br>/ Model: ZEN-7000 |
|-------------------------|--------------------------------------------------------------------------------------|
| Common/Usual Name: | Fluoroscopic X-Ray System |
| Classification Name: | System, X-Ray, Fluoroscopic, Image-Intensified /<br>System, X-Ray, Mobile |
| Product Code: | JAA / IZL |
| Device Class: | Class II per regulation 21 CFR 892.1650 /<br>Class II per regulation 21 CFR 892.1720 |

### Equivalent Legally Marketed Device 4.

| Manufacturer: | GE OEC Medical Systems, Inc |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | OEC 9800 Plus |
| 510(k) Number: | K021049 (Decision Date - April 17, 2002) |
| Classification: | System, X-Ray, Fluoroscopic, Image-Intensified: JAA,<br>Class II per regulation 21 CFR 892.1650 /<br>System, X-Ray, Mobile: IZL,<br>Class II per regulation 21 CFR 892.1720 |

K103425

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## 5. Description of the Device

ZEN-7000 mobile fluoroscopy system is an image intensified fluoroscopic system consisting of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and an image intensifier. The Mainframe is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The Workstation is a mobile platform that supports image display monitors and recording devices.

# 5.1 Specification of ZEN-7000

- : High Frequency Inverter · Generator
- ◆ Max. output power : 5 kW
- X-ray tube : Rotating tube
- Fluoroscopy : 40~120 kV / 0.2~6.0 mA
- Radiography : 40~120 kV / 20 mA
- · TV Camera : CCD Type
- : 9"(9"/6"/4.5") · Image Intensifier
- C-arm wig wag : ±12.5°
- · Orbit. Rotation : 1356
- : 200 mm ◆ Horiz. Travel
- : 450 mm ◆ Vert. Travel

## 6. Indications for use

ZEN-7000 Digital mobile Imaging system is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

# 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.

### 8. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided the above comparison table, the GENORAY Co., Ltd., concludes that the Fluoroscopic X-Ray System (Model: ZEN-7000) is safe and effective and substantially equivalent to the predicate device as described above.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

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

MAR 2 9 2011

Re: K103425

Trade/Device Name: Fluoroscopic X-Ray System (Models: ZEN-7000) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and IZL Dated: February 10, 2011 Received: February 18, 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 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,

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 Exhibit 4

510(k) number (if known): Yo 3 T

Device Name: Fluoroscopic X-Ray System (Models: ZEN-7000)

Indications for Use:

ZEN-7000 Digital mobile Imaging system is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

| Prescription Use | AND/OR | Over-The-Counter Use |
|---------------------------------|--------|-----------------------------|
| V<br>(Part 21 CFR 80 Subpart D) | | (Part 21 CFR 801 Subpart Q) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Pastel

510K K163425