VIDAR DENTAL FILM DIGITIZER

K093809 · Vidar Systems Corp. · LMA · Jan 7, 2010 · Radiology

Device Facts

• Record ID: K093809
• Device Name: VIDAR DENTAL FILM DIGITIZER
• Applicant: Vidar Systems Corp.
• Product Code: LMA · Radiology
• Decision Date: Jan 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The VIDAR dental film digitizer is used for making digital copies of x-ray film commonly used in dental practices. Images captured with this device are intended for use in primary, secondary and over-reading applications. The target users of the device are medical professional or trained staff.

Device Story

Device converts analog dental x-ray films into digital format; utilizes high-end imaging components for low-noise, high-resolution reproduction. Operated by dental professionals or trained staff in dental practice settings. Input is physical x-ray film; output is digital image file. Digital images support primary diagnosis, secondary review, and over-reading workflows. Benefits include transition from analog to digital storage and viewing, facilitating clinical decision-making through improved image accessibility and management.

Clinical Evidence

Bench testing only. Performance testing demonstrated the device meets requirements for its intended use, including optical resolution, grayscale bit-depth, and optical density sensitivity.

Technological Characteristics

Optical resolution: 300 dpi; 16-bit grayscale; optical density sensitivity (DMAX) of 4.1 OD; medical OD range 0.2 - 3.6. Incorporates noise and linearity measurements.

Indications for Use

Indicated for dental professionals or trained staff to create digital copies of dental x-ray films for primary, secondary, and over-reading clinical applications.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The 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

• Vidar Sierra (P111) (K993597)
• TeleRADPro (K993597)
• VXR-12 plus Film Digitizers (K993597)

Submission Summary (Full Text)

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KC938509

510(k) Summary

JAN - 7 2010

Submitter: VIDAR Systems Corporation 365 Herndon Parkway Herndon, VA 20170 U.S.A. 703-471-7070 (phone) 703-471-1165 (fax)

Official Correspondent: Carrie L. Brancart Date of Submittal: November 30, 2009 Trade Name: Dental Film Digitizer Common Name: X-Ray Film Digitizer Classification Name: Medical Image Digitizer (21CFR892.2030) Product Code: LMA Predicate Device: Trade Name: Vidar Sierra (P111), TeleRADPro and VXR-12 plus Film Digitizers

510(k): K993597

Manufacturer: VIDAR Systems Corporation

## Device Description:

The Dental Film Digitizer is a medical device used to convert x-ray films into a digital format. The device uses high end imaging components and design characteristics specifically geared towards the complexity of x-ray film data; offering the user a low noise, high resolution reproduction of the medical film.

#### Intended Use:

The VIDAR dental film digitizer is used for making digital copies of x-ray film commonly used in dental practices. Images captured with this device are intended for use in primary, secondary and over-reading applications. The target users of the device are medical professional or trained staff.

365 Herndon Parkway Hemdon, VA 20170 · USA

800.471.SCAN +1:703.471.7070 Fax: [phone]

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Image /page/1/Picture/0 description: The image shows the logo for VIDAR systems corporation. The logo is black and white and features the company name in a bold, sans-serif font. Below the company name is the tagline "The Image of Reliability" in a smaller font. The logo is simple and professional, and it conveys a sense of trust and dependability.

## Technological Characteristics:

The VIDAR Dental Film Digitizer offers a high optical resolution of 300 dpi; 16-bit grayscale, optical density sensitivity (DMAX) of 4.1 OD, and a medical OD range of 0.2 - 3.6 (incorporates noise and linearity measurements).

### Performance Testing:

VIDAR conducts extensive performance testing and the test results demonstrate the device meets the requirements for its intended use. Please see Section 19 Bench Testing.

## Substantial Equivalence to Predicate Device:

The VIDAR Dental Film Digitizer is substantially equivalent to the VIDAR Sierra (P111), TeleRADPro and VXR-12 plus Film Digitizers. The comparison table of the principal characteristics of the two devices is shown in Section 13 and specification data for the VIDAR Dental Film Digitizer is included in Section 12.

### Conclusion:

In terms of intended use, function, safety, operating environmental conditions and effectiveness of the VIDAR Dental Film Digitizer it is determined to be substantially equivalent to the predicate device used for this application.

365 Herndon Parkway Herndon, VA 20170 • USA

+1.703.471.7070

. 800.471.SCAN

Fax: [phone]

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Public Health Service

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

> •

# JAN - 7 2010 -

VIDAR Systems Corporation % Mr. John Howlett Head of BSI Medical Device Notified Body BSI Group Healthcare, British Standards Institution Maylands Avenue, Hemel Hempstead, Herts HP2 4SQ UNITED KINGDOM

Re: K093809

Trade/Device Name: Dental Film Digitizer Regulation Number: 21 CFR 872.2030 Regulation Name: Medical Image Digitizer Regulatory Class: II Product Code: LMA Dated: December 3, 2009 Received: December 9, 2009

Dear Mr. Howlett:

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to prematket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VIDAR Systems Corporation

K 093809

## INDICATIONS FOR USE

510(k) Number (if known):

K09380 9

Device Name: Dental Film Digitizer

Indications for Use:

The VIDAR dental film digitizer is used for making digital copies of x-ray film commonly used in dental practices. Images captured with this device are intended for use in primary, secondary and over-reading 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*(Division Sign-Off)*

Division of Reproductive. Abdominal, and Radiorogical Devices

510(k) Number _

80/