VIDAR VISION 2000

K070563 · Vidar Systems Corp. · MQB · Mar 16, 2007 · Radiology

Device Facts

• Record ID: K070563
• Device Name: VIDAR VISION 2000
• Applicant: Vidar Systems Corp.
• Product Code: MQB · Radiology
• Decision Date: Mar 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The VIDAR Vision 2000 is indicated for use in generating radiographic images of human anatomy. It is a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. The VIDAR Vision 2000 is not indicated for diagnostic X-ray mammography.

Device Story

VIDAR Vision 2000 is a solid-state X-ray imaging system (digital radiography) designed to replace traditional film/screen systems. It captures X-ray signals to produce digital radiographic images of human anatomy. Used in clinical settings for general-purpose diagnostic procedures; operated by trained healthcare professionals. The device is physically and electrically identical to the predicate device (K974863). It provides digital images to clinicians to assist in diagnostic decision-making, offering the benefits of digital radiography over film-based systems.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on physical and electrical identity to the predicate device.

Technological Characteristics

Solid-state X-ray imager (flat panel/digital imager). Device is physically and electrically identical to the predicate device (K974863).

Indications for Use

Indicated for generating radiographic images of human anatomy for 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

• IMIX-ADR Digital Radiography System (K974863)

Submission Summary (Full Text)

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Tab 1 - Cover Letter Traditional 510(k)

# TRADITIONAL 510(K) SUBMISSION

Submission Date: February 14, 2007 (Month/dd/yyyy)

# Name & Address of BSI Authorized Person:

John Howlett, Head of BSI Medical Device Notified Body, BSI Group, Product Services, British Standards Institution, Maylands Avenue. Hemel Hempstead, Herts HP2 4SQ ામ

Phone: [phone] FAX: [phone]

### Name & Address of BSI Technical Reviewer:

Andre Routh, PhD., Senior Product Expert, BSI Product Services - Healthcare, 12110 Sunset Hills Road, Suite 200 Reston, VA 20190

Phone/FAX: [phone]

#### Name & Address of 510(K) Submitter:

Carrie L. Brancart VIDAR Systems Corporation 365 Herndon Parkway Herndon, VA 20170

Phone: [phone] FAX: [phone]

Date received: February 05, 2007

Device Trade Name: VIDAR Vision 2000 Device Common Name: Digital Radiography Image Acquisition System

#### FDA Classification:

Device Class: II Panel: Radiology Product Code: MQB Regulation Number: 892.1650 Device: Solid state x-ray imager (flat panel/digital imager)

FEB 2 7 2007

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#### Tab 1 - Cover Letter Traditional 510(k)

#### Consultation with FDA Branch Chief. Team Leader or Designate

Andre Routh, the BSI Technical Reviewer, spoke with Dr. Robert Phillips (Supervisory Physicist, DHHS/ FDA/ CDRH/ ODE/ DRARD/ RDB) on January 25, 2007 to identify relevant issues and review criteria. Dr. Routh had previously sent an email introducing himself and the VIDAR Vision 2000 system (January 22, 2007). During the discussion, Dr. Phillips suggested that VIDAR request a letter from IMIX (Tampere, Finland) permitting VIDAR to include by reference the data submitted by IMIX to FDA in K974863. Unfortunately, the agreement between VIDAR and IMIX did not extend to the exchange of such information so the present submission follows the Traditional 510(k) format.

#### BSI Recommendation Regarding Substantial Equivalence:

The VIDAR VISION 2000 is currently manufactured by IMIX-ADR( Tampere, Finland) under the Premarket Notification of the predicate device (K974863). VIDAR intends to market this device under its own name. The device is physically and electrically (including software) identical to the predicate.

The labeling for the subject device has been reviewed to verify that the indication/intended use for the device is unaffected.

Based on the evidence supplied by the submitter, I recommend the device be determined substantially equivalent to the previously cleared device.

#### BSI Authorized Person

**Signature:**

John Howlett, Head of BSI Medical Device Notified Body

Date: February/22/2007
(Month/dd/yyy)

BSI Technical Reviewer

Signature: Andrei C. Rindt

**Andre G. Routh, PhD, Senior Product Expert**

Date: Feb 14, 2007
(Month/dd/yyyy)

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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. John Howlett British Standards Institution Product Services Maylands Avenue HEMEL HEMSTEAD HP2 4SQ UNITED KINGDOM

AUG 2 3 2013

Re: K070563

Trade/Device Name: VIDAR Vision 2000 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: February 14, 2007 Received: February 27, 2007

Dear Mr. Howlett:

This letter corrects our substantially equivalent letter of March 16, 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):___K070563

Device Name:___VIDAR Vision 2000

Indications For Use:

"The VIDAR Vision 2000 is indicated for use in generating radiographic images of human anatomy. It is a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures.

The VIDAR Vision 2000 is not indicated for diagnostic X-ray mammography."

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Hogdon

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

(Division Sign-Off))

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070563