ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM

K061534 · Ziehm Imaging, Inc. · OWB · Jul 7, 2006 · Radiology

Device Facts

• Record ID: K061534
• Device Name: ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
• Applicant: Ziehm Imaging, Inc.
• Product Code: OWB · Radiology
• Decision Date: Jul 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Indications for Use

The Ziehm Vision FD is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. Is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in image geometry is required. At the discretion of a physician the device may be used for other imaging applications.

Device Story

Mobile C-arm fluoroscopic imaging system; utilizes high-frequency X-ray generator, X-ray tube, and solid-state flat panel detector (SSXI) to capture real-time images. System comprises mobile stand with C-profile and monitor cart workstation. Operator (physician, surgeon, cardiologist, radiologist, or technologist) positions C-arm via rotational/linear movements; integrated laser localizers assist positioning. Workstation processes, displays, and stores images via Vision II digital memory and VisionCenter touch interface. Output viewed on dual LCD monitors; supports DICOM 3, external media, and video peripherals. Provides high-accuracy image geometry for complex anatomical visualization; assists clinical decision-making during procedures in hospitals and clinics.

Clinical Evidence

Bench testing only. Compliance with 21 CFR 1020.30/31 and IEC 60601 series standards for safety, radiation protection, and electromagnetic compatibility.

Technological Characteristics

Mobile C-arm with high-frequency generator and solid-state flat panel detector (SSXI). Dual LCD monitor workstation. Connectivity: DICOM 3, RS-170/CCIR video, external media storage. Standards: 21 CFR 1020.30/31, UL 60601-1, IEC 60601-1, 1-2, 1-3, 1-4, 2-7, 2-28, 2-32, IEC 60825-1 (laser), DIN ISO 14971.

Indications for Use

Indicated for patients undergoing diagnostic, interventional, and surgical procedures requiring fluoroscopic imaging, including vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, 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

• ZIEHM VISION Digital Mobile Imaging System (K011292)

Submission Summary (Full Text)

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## 510(k) Summary

In accordance with the requirements of 21 CFR §807.92 the following summary of 510(k) safety and effectiveness information for the Zichm Vision FD is being submitted.

Date:

May 29, 2006

## Name of Submitter:

Zichm Imaging, Inc. 4181 Latham Street Riverside, CA 92501 [phone]

## Corresponding Official:

Richard Westrich, V.P. Product Development, Regulatory Affairs

## Device Proprietary Name:

Ziehm Vision FD Digital Mobile Imaging System

#### Classification Name:

System, X-ray, Fluoroscopic, Image-Intensified Solid State X-ray Imager (flat panel/digital imager)

#### Common/Usual Names:

Digital Mobile Imaging System

Fluoroscopic Imaging System

Digital Mobile C-arm,

## Substantial Equivalence:

The ZIEHM VISION FD product does not raise new questions of safety or effectiveness and is substantially equivalent to the following current legally marketed devise ZIEHM VISION.

- Ziehm Imaging, Inc. ZIEHM VISION Digital Mobile Imaging System 510(k) -K011292
The device is a mobile C-arm type x-ray system intended for fluoroscopic imaging. The systems include high-voltage x-ray generator, and control, fixed anode x-ray tube, image intensifier, touch control user interface and monitor cart/workstation with video image displays, digital image processing and image storage capabilities.

K061534

JUL - 7 2006

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#### Device Description:

#### Indications for Use

The Zichm Vision FD is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. Is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in image geometry is required. At the discretion of a physician the device may be used for other imaging applications.

#### User Characteristics

The device is intended for use by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists in hospitals, out-patient clinics and other clinical environments. Ziehm Imaging anticipates the device will be used on a nearly daily basis. Zichm Imaging applications specialists and/or qualified site personnel provide on site operator training in the proper use of the device.

#### General Description

The ZIEHM VISION FD has two main units; Mobile Stand and Monitor Cart workstation. The Mobile Stand C-arm consists of a high frequency generator, X-ray Tube assembly, Solid State X-Ray Imager / Flat Panel Detector, user touch control interface, C-Profile supporting the generator and Solid State X-ray Imager (SSXI), and Integrated Laser light localizers in the image receptor. The Mobile Stand C-profile provides fixed distance mounting of the generator and image receptor allowing the user rotational and linear movements for positioning the c-arm at various angles and distances for visualization of patient's anatomical structures.

The monitor cart workstation supports dual flat panel LCD display monitors, Vision II digital image memory device, imaging capture, image processing, and VisionCenter touch control user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets. The Vision FD also provides optional peripheral connections for such devices as video printers, DICOM 3 and external media storage devices.

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### Standards:

The ZIEHM VISION FD series mobile x-ray systems were designed to comply with applicable portions of the following standards and regulations for product safety requirements:

- Federal Performance Standard for Diagnostic X-ray Systems 21 CFR 1020.30, 21 CFR -1020.31 and 21 CFR 1020.30
- l UL 60601-1 Medical Electrical Equipment
- ー IEC 6060'1-1. Medical Electrical Equipment, General Requirements for Safety
- IEC 60601-1-2, Medical Electrical Equipment, General Requirements for Safety, l Electromagnetic Compatibility
- l IEC 60601-1-3, Mcdical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment
- । IEC 60601-1-4, General requirements for safety, Programmable electrical medical systems.
- IEC 60601-2-7. Modical Electrical Equipment, Safety of HV/X-ray i Generators
- IEC 60601-2-28, Medical Electronic, Particular Requirements for Safety । of X-ray Source Assemblies, and X-ray Tube Assemblies.
- । IEC 60601-2-32, Medical Electrical Equipment, Safety of Associated X-ray Equipment
- IEC 60825-1. Safety of Laser Products, Equipment Safety , । Requirements, and User Guide
- 93/42/EEC Annex 1 Essential Requirements of the Medical । Devices Directive
- । DIN ISO 14971

#### Conclusion:

The ZIEHM VISION FD does not raise new questions of safety or effectiveness and is substantially equivalent to the current model Ziehm Vision with image intensifier K011292.

End of 510(k) Summary

Richard Vice President Product Development and Regulatory Affairs Ziehm Imaging, Inc.

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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 and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

# FEB 1 9 2013

Mr. Richard Westrich Vice President of Product Development and Regulatory Affairs Ziehm Imaging, Inc. 4181 Latham Street RIVERSIDE CA 92501

Re: K061534

Trade/Device Name: Zeihm Vision FD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: May 29, 2006 Received: June 2, 2006

Dear Mr. Westrich:

This letter corrects our substantially equivalent letter of July 7, 2006.

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,

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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Image /page/5/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic to the left of the company name. The graphic appears to contain a figure within a circular design. The text "ziehm imaging" is written in a sans-serif font.

## Indications For Use Statement:

Applicant:

Ziehm Imaging, Inc.

510(k) Number (if known):

Device Name:

ZIEHM VISION FD

1534

Intended Use:

The Ziehm Vision FD is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. Is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in image geometry is required. At the discretion of a physician the device may be used for other imaging applications.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brodon
Division Sign-Off
Division of Reproductive, Abdominal

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061534

Ziehm Imaging, Inc. an Ziehm I 4181 Latham Street . Riverside CA. 92501 USA . Tel. [phone] . Fax [phone] http://www.Zichm.com