VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS

K071193 · Vidar Systems Corp. · MQB · May 30, 2007 · Radiology

Device Facts

• Record ID: K071193
• Device Name: VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS
• Applicant: Vidar Systems Corp.
• Product Code: MQB · Radiology
• Decision Date: May 30, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. The Vidar Vision 3000 and Vidar Vision 4000 is not indicated for diagnostic X-ray mammography.

Device Story

Vidar Vision 3000 and 4000 are stationary digital radiography (DR) systems for general-purpose diagnostic imaging. Systems combine X-ray generators with solid-state digital detectors (3K detector for Vision 3000; 4K detector for Vision 4000). Operated by clinicians in imaging centers, orthopedic practices, and hospitals via software-driven touch panel LCDs and remote consoles. Devices capture X-ray signals, converting them into high-resolution digital images to replace traditional film/screen systems. Output is displayed for physician review to support clinical decision-making. Benefits include rapid image acquisition, improved productivity, and high-resolution imaging.

Clinical Evidence

Bench, user, and standards testing performed. No clinical trial data provided.

Technological Characteristics

Stationary X-ray system; solid-state digital detector (160-micron pitch for 3000; 120-micron pitch for 4000); software-driven touch panel LCD control; 50-80 kW generator output; Balco B302I/A DHHS collimator.

Indications for Use

Indicated for generating radiographic images of human anatomy in general-purpose diagnostic procedures. Not indicated for diagnostic X-ray mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.

Predicate Devices

• SEDECAL Universal Radiographic Systems (K012546)
• Vidar 2000 Digital Radiographic Detector (K070563)
• Sedecal URS LP X-Ray Units with Digital Detector (K042876)

Reference Devices

• CANON CXDI-50G (K031447)

Submission Summary (Full Text)

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K071193

MAY 3 0 2007

Image /page/0/Picture/2 description: This image shows the letterhead for VIDAR systems corporation. The letterhead includes the company logo, address (365 Herndon Parkway, Herndon, VA 20170), phone numbers (800.471.7226, +1.703.471.7070), and fax number (+1.703.471.7665). The contact person is Carrie L. Brancart, Quality Manager, and the date prepared is May 13, 2007.

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- 1. Identification of the Device: Proprietary-Trade Name: Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems Classification Name: Stationary X-ray system, Product Codes Product Code 90 KPR and MQB Common/Usual Name: General purpose diagnostic X-ray Unit.
- 2. Equivalent legally marketed devices: This notification is for a MODIFIED device. This device COMBINES two 510(k) cleared devices, the SEDECAL Universal Radiographic Systems K012546 AND the Vidar 2000 Digital Radiographic Detector, K070563. This combination is functionally identical to a SEDECAL cleared device, Sedecal URS LP X-Ray Units with Digital Detector, K042876 ..
- 3. Indications for Use (intended use) Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. The Vidar Vision 3000 and Vidar Vision 4000 is not indicated for diagnostic X-ray mammography.
- 4. Description of the Device: The VIDAR VISION 3000 Digital Radiography system is an affordable DR (Digital Radiographic) solution designed for smaller radiography environments, including imaging centers, orthopedic practices, small hospitals, and outpatient areas of hospitals. The VIDAR VISION 3000 is the first truly affordable, full-featured DR system. providing a total solution for all digital radiographic examinations. The VIDAR VISION 3000 features high image quality, rapid image acquisition, improved productivity, and ease of use. The flexible system features a 3K detector for the high-resolution imaging needs of busy radiology centers, orthopedic practices, and hospitals. VIDAR's new VISION DR product line also includes the VISION 4000 system, with a 4K detector that is ideal for higher volume settings.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.

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- 6. Substantial Equivalence Chart, Vidar Vision 3000 and Vidar Vision 4000
:

Y

| Characteristic | Sedecal URS X-Ray<br>Units with Digital<br>Detector<br>K042876 | Vidar Vision 3000<br>and Vidar Vision<br>4000<br>Combines two<br>cleared devices:<br>K070563 AND<br>K012546 |
|--------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | General purpose<br>diagnostic X-ray unit | SAME |
| User Interface | Depends on Control<br>Console option chosen.<br>Mainly dedicated touch<br>controls | Software Driven Touch<br>Panel LCD, + remote<br>control unit + remote<br>console |
| Maximum output | Depends on model of<br>generator chosen.<br>Models available from<br>30 kW to 64 kW | 50, 64, and 80 kW |
| Image Acquisition | Digital: CANON<br>CXDI-50G.<br>K031447 | Digital: Vidar Digital<br>Radiographic Detector<br>K070563 |
| Digital Panel Size | Up to 14" x 17" active<br>area | Vision 3000/4000:<br>Active image size: 16 x<br>16 inches (40cm x 40cm) |
| Digital Resolution | 160 x 160 microns<br>pixel pitch, with<br>approximately 6<br>million pixels | Vision 3000:<br>160 Micron.<br>3056 x 3056 (9<br>megapixels)<br><br>Vision 4000:<br>120 Micron<br>4096 x 4096 (16<br>megapixels) |
| Method of Control | Dedicated push button<br>Controls | Software Driven Touch<br>Panel LCD |
| Collimator | Manual R302/A | Balco B302I/A DHHS |

7. Conclusion After analyzing bench, user, and standards testing data, it is the conclusion of Vidar Systems that the Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are as safe and effective as the predicate devices, have tew technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes a symbol with three blue lines and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The symbol is on the left side of the text.

Public Health Service

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

Vidar Systems Corporation % Mr. Daniel Kamm Principal Consultant Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

AUG 2 3 2013

Re: K071193

Trade/Device Name: Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: April 24. 2007 Received: April 30, 2007

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of May 30, 2007.

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, 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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## Indications for Use

510(k) Number (if known): K071193

Device Name: Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems

Indications For Use:

Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. The Vidar Vision 3000 and Vidar Vision 4000 is not indicated for diagnostic X-ray mammography.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hul
(Division Sigh-Off)
Division of Reproductive, Abdominal, and

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

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