(88 days)
Not Found
No
The description focuses on the hardware and driver software for digitizing X-ray film. There is no mention of AI, ML, or any advanced image processing beyond simple digitization.
No
The device is a digitizer that converts X-ray film into digital data for consultation, review, and final interpretation, but it does not treat or cure any medical condition.
No.
The device converts X-ray film into digital data. It is explicitly stated that the device does not supply a diagnostic result and is not intended for primary diagnosis in mammography. Its use is limited to secondary capture images for consultation, review, and final interpretation.
No
The device description explicitly states it consists of a film digitizer with hardware components like a film feeder, power adapter, optics (LED, lens, mirrors), a CCD detector, and a stepper motor, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TeleradPRO Edge and TeleradPRO Edge HD-CCD digitizers are used to create digital copies of existing medical x-ray films. They are essentially scanners for film.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from a patient. Its input is a physical film.
- No Diagnostic Result Provided: The description explicitly states, "This device has no patient contact and does not supply a diagnostic result. The film digitizer only provides digital data representing the film."
Therefore, since the device does not perform tests on biological samples and does not provide a diagnostic result based on such tests, it does not fit the definition of an In Vitro Diagnostic device. It is a medical device used for digitizing existing medical images.
N/A
Intended Use / Indications for Use
The TeleradPRO Edge and TeleradPRO Edge HD-CCD digitizers are used for making digital copies of medical x-ray film, including printed and radiographic film. The target users of these devices are medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation.
These devices are not intended to be used for primary diagnosis in mammography applications.
Product codes (comma separated list FDA assigned to the subject device)
LMA
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 used with DICOM standard software that meets or exceeds ACR and DICOM standards for use of secondary capture images for consultation, review and final interpretation.
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 or blue LED illuminator, a lens, mirrors, and a CCD linear array detector.
This device has no patient contact and does not supply a diagnostic result. The film digitizer only provides digital data representing the film.
Mentions image processing
Not Found
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 professionals 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for VIDAR Systems Corporation, which is a 3D Systems Company. The logo features a stylized "V" followed by the word "IDAR" in bold, sans-serif font. Below the company name, it says "systems corporation" in a smaller font, and below that, it says "A 3D Systems Company."
K130636
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JUN 0 7 2013
510(k) Summary
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: 2/14/13 Trade Names: TeleradPRO Edge and TeleradPRO Edge HD-CCD Common Name: X-Ray Film Digitizer Classification Name: Medical Image Digitizer (21CFR892.2030) Product Code: LMA Predicate Device: Trade Name: TeleradPRO 510(k): K102476
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 used with DICOM standard software that meets or exceeds ACR and DICOM standards for use of secondary capture images for consultation, review and final interpretation.
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 or blue LED illuminator, a lens, mirrors, and a CCD linear array detector.
This device has no patient contact and does not supply a diagnostic result. The film digitizer only provides digital data representing the film.
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K130636
Page 2 of 2
Image /page/1/Picture/1 description: The image shows the logo for VIDAR systems corporation, a 3D Systems Company. The logo features a horizontal line to the left of the word "VIDAR" in large, bold letters. Below "VIDAR" is the text "systems corporation" in a smaller font. Underneath that is the text "A 3D Systems Company".
Intended Use:
The TeleradPRO Edge and TeleradPRO Edge HD-CCD digitizers are used for making digital copies of medical x-ray film, including printed and radiographic film. The target users of these devices are medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation.
These devices are not intended to be used for primary diagnosis in mammography applications.
Technological Characteristics:
The VIDAR TeleradPRO Edge film digitizer offers a high spatial resolution of 600 dpi; 16-bit grayscale, optical density sensitivity (DMAX) of 5.1 OD, and a medical OD range. of 0.2 - 3.2 (incorporates noise and linearity measurements).
The VIDAR TeleradPRO Edge HD-CCD film digitizer offers a high spatial resolution of 600 dpi: 16-bit gravscale, optical density sensitivity (DMAX) of 5.5 OD, and a medical OD range of 0.1 - 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.
Substantial Equivalence to Predicate Device:
The TeleradPRO Edge and TeleradPRO Edge HD-CCD are substantially equivalent to the VIDAR TeleradPRO film digitizer.
Conclusion:
In terms of intended use, function, safety, operating environmental conditions and effectiveness of the TeleradPRO Edge and TeleradPRO Edge HD-CCD it is determined to be substantially equivalent to the predicate device used for this application.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
e
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2013
VIDAR Systems Corporation % Ms. Carrie L. Brancart Director, QA/RA 365 Herndon Parkway HERNDON VA 20170
Re: K130636
Trade/Device Name: TeleradPRO Edge and TeleradPRO Edge HD-CCD Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: LMA Dated: March 6, 2013 Received: March 11, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
3
Page 2 - Ms. Brancart
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket 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/Safetv/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K130636
Device Name: TeleradPRO Edge and TeleradPRO Edge HD-CCD
Indications for Use:
The TeleradPRO Edge and TeleradPRO Edge HD-CCD digitizers are used for making digital copies of medical x-ray film, including printed and radiographic film. The target users of these devices are medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation.
These devices are not intended to be used for primary diagnosis in mammography applications.
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 In Vitro Diagnostics and Radiological Health (OIR)
Sinh)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130636 510(k)
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