(29 days)
No
The summary describes a film digitizer that converts x-ray film to digital format. There is no mention of AI, ML, or any advanced image analysis beyond basic digitization.
No
Explanation: The device is a dental film digitizer used to convert x-ray films into a digital format for diagnostic purposes, not for treating any medical condition.
No
Explanation: The device is a digitizer that converts x-ray films into a digital format. While the digital copies are used in diagnostic applications, the digitizer itself does not perform any diagnostic function; it simply facilitates the digital viewing of existing x-ray films.
No
The device description explicitly states it uses "high end imaging components and design characteristics," indicating it is a hardware device that converts x-ray film to digital format.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The VIDAR dental film digitizer works with x-ray film, which is an image of the inside of the body, not a biological specimen.
- The intended use is to digitize existing x-ray films for viewing and analysis. It doesn't perform any tests or analyses on biological samples.
The device is clearly described as a medical device used to convert x-ray films into a digital format for use in dental practices. This aligns with the function of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
LMA
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray film
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professional or trained staff.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
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.
0
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: +1.703.471.1165
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1
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: +1.703.471.1165
6-2
2
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 (800) 638-2041 or (301) 796-7100 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
4
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/