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 Description

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.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or an in-depth study proving that the device, a Fluoroscopic X-Ray System (Model: ZEN-7000), meets explicit performance metrics.

Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (GE OEC Medical Systems, Inc. OEC 9800 Plus, K021049). This type of submission generally relies on comparing the technical specifications and indications for use of the new device to the predicate, rather than providing extensive de novo clinical trial data with acceptance criteria and statistical proof.

Here's a breakdown of what can be inferred or is explicitly stated, with limitations due to the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the format of a table with pass/fail thresholds. Instead, it lists the specifications of the ZEN-7000, implying that these align with or are comparable to those of a predicate device.

Feature / Metric	Acceptance Criteria (Implied)	Reported Device Performance (ZEN-7000)
Max. output power	Comparable to predicate device for safety & effectiveness	5 kW
X-ray tube	Comparable to predicate device	Rotating tube
Fluoroscopy kV	Within acceptable range for listed applications	40~120 kV
Fluoroscopy mA	Within acceptable range for listed applications	0.2~6.0 mA
Radiography kV	Within acceptable range for listed applications	40~120 kV
Radiography mA	Within acceptable range for listed applications	20 mA
TV Camera Type	Comparable to predicate device for imaging quality	CCD Type
Image Intensifier	Comparable to predicate device in size/functionality	9" (9"/6"/4.5")
C-arm wig wag motion	Functional for versatile positioning	±12.5°
Orbit. Rotation	Functional for versatile positioning	135°
Horiz. Travel	Functional for patient positioning	200 mm
Vert. Travel	Functional for patient positioning	450 mm
Indications for Use	Comparable to predicate device	Fluoroscopic and spot-film imaging during diagnostic, surgical, and interventional procedures (cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench and clinical evaluation" in a very general sense. It does not provide details on:

The sample size of patients or images used in any "clinical evaluation."
The country of origin for any data.
Whether any data was retrospective or prospective.

Given the nature of a 510(k) for an X-ray system, "clinical evaluation" often refers to demonstrating the system produces images of diagnostic quality, which might involve a limited number of phantom and/or human subject images, but not a large-scale clinical trial with statistical power for "performance."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document primarily focuses on technical specifications and substantial equivalence, not a study involving expert readers and ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. As no specific study with expert readers and ground truth is detailed, no adjudication method would be mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done (or at least, not reported in this document).
The device is a conventional fluoroscopic X-ray system, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware device (X-ray system), not an algorithm or AI software. Therefore, a standalone algorithm performance study is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. As no specific diagnostic accuracy study is detailed, the type of ground truth is not mentioned. For a conventional X-ray system, "ground truth" for proving efficacy often relates to image quality metrics (resolution, contrast, noise) and dose, which are typically assessed through phantom studies and engineering specifications, rather than clinical diagnostic endpoints requiring pathology or outcome data in the context of a 510(k) submission.

8. The sample size for the training set

Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a hardware device, not a machine learning algorithm.

Summary

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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.:	+82-31-740-4100
Fax:	+82-31-737-8025

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

K103425

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5. Description of the Device

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

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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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:

Prescription Use	AND/OR	Over-The-Counter Use
V(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

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
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.(b)
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.