TELERADPRO

K102476 · Vidar Systems Corp. · LMA · Oct 7, 2010 · Radiology

Device Facts

• Record ID: K102476
• Device Name: TELERADPRO
• Applicant: Vidar Systems Corp.
• Product Code: LMA · Radiology
• Decision Date: Oct 7, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The VIDAR TeleradPRO film digitizer is used for making digital copies of medical x-ray films.

Device Story

TeleradPRO is a film digitizer designed to convert medical X-ray films into digital data. The device features a film feeder (single or multi-film), an external power adapter, and Windows driver software. Operation involves feeding X-ray film via rollers driven by a stepper motor past scan optics, which include a white LED illuminator, lens, mirrors, and a CCD linear array detector. The digitizer connects to a PC via a USB 2.0 interface. The Windows driver software facilitates the import of digital data into compatible medical software applications. Used in clinical environments, the device allows healthcare providers to view and manage digitized X-ray images, supporting clinical decision-making by providing digital access to film-based diagnostic information.

Clinical Evidence

Bench testing only. Performance testing demonstrated the device meets requirements for its intended use, including optical resolution of 300 dpi, 16-bit grayscale, and optical density sensitivity (DMAX) of 4.8 OD.

Technological Characteristics

Film digitizer with stepper motor-driven rollers. Scan optics: white LED illuminator, lens, mirrors, CCD linear array detector. Connectivity: USB 2.0 to PC. Resolution: 300 dpi. Grayscale: 16-bit. Optical density sensitivity (DMAX): 4.8 OD. Medical OD range: 0.2 - 3.2. Software: Windows driver for data import.

Indications for Use

Indicated for the creation of digital copies of medical X-ray films for clinical use.

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

• TeleRADPro Film Digitizers (K993597)

Submission Summary (Full Text)

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K 102476
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Image /page/0/Picture/1 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". The logo is simple and professional, and it conveys a sense of quality and dependability.

### 510(k) Summary

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

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Official Correspondent: Carrie L. Brancart Date of Submittal: August 23, 2010

Trade Name: TeleradPRO

X-Ray Film Digitizer Common Name:

Classification Name: Medical Image Digitizer (21 CFR 892.2030) Product Code: LMA Predicate Device: Trade Name: TeleRADPro Film Digitizers 510(k): K993597

Manufacturer: VIDAR Systems Corporation

### Device Description:

The device consists of a film digitizer with single-film or multi-film feeder, external power adapter, and Windows driver software. The film digitizer will convert the X-ray film into digital data representing the X-ray film, and the windows driver software is used to import the digital data into a compatible software application

The Digitizer is connected to a PC through a USB 2.0 interface. The digitizer utilizes rollers driven by a stepper motor to feed the X-ray film past the scan optics. The scan optics consists of a white LED illuminator, a lens, mirrors, and a CCD linear array detector.

#### Intended Use:

The VIDAR TeleradPRO film digitizer is used for making digital copies of medical x-ray films.

The intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.

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Image /page/1/Picture/1 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". The logo is simple and professional, and it conveys a sense of trust and quality.

## Technological Characteristics:

The VIDAR TeleradPRO film digitizer offers a high optical resolution of 300 dpi; 16-bit grayscale, optical density sensitivity (DMAX) of 4.8 OD, and a medical OD range of 0.2 - 3.2 (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 22 Bench Testing.

# Substantial Equivalence to Predicate Device:

The TeleradPRO is substantially equivalent to TeleRADPro film digitizer. The comparison table of the principal characteristics of the two devices is shown in Section 14 and specification data for the TeleradPRO is included in Section 13.

## Conclusion:

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

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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 pattern 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

Ms. Carrie L. Brancart Director, Quality Assurance and Regulatory Affairs Vidar Systems Corporation 365 Herndon Parkway HERNDON VA 20170

DCT 7 2010

Re: K102476

Trade/Device Name: TeleradPRO Regulation Number: 21 CFR 892.2020 Regulation Name: Medical image communications device Regulatory Class: II Product Code: LMA Dated: August 23, 2010 Received: August 30, 2010

Dear Ms. Brancart:

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.

David G. Brown, Ph.D. 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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VIDAR Systems Corporation

K 102476

#### INDICATIONS FOR USE

510(k) Number (if known):

Device Name: TeleradPRO

Indications for Use:

The TeleradPRO film digitizer is intended for making digital copies of medical xray films.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office affer and sation (ODE) OJU

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K162476