(85 days)
Not Found
No
The summary describes a device that converts analog x-ray films to digital data, which is a standard digitization process. There is no mention of AI, ML, or advanced image processing techniques that would suggest the use of such technologies.
No
The device is described as an x-ray film digitizer used to convert analog x-ray films into digital data, which is a diagnostic function, not a therapeutic one.
No
The device is described as an "x-ray film digitizer" which converts analog x-ray films into digital data. Its "Intended Use / Indications for Use" is "producing digital copies of medical x-ray films." This describes a device for digitizing images, not for diagnosing medical conditions. Diagnosis typically involves interpreting images or test results, which this device does not do.
No
The device description explicitly states it is an "electronic device" that converts analog films to digital data, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce digital copies of medical x-ray films. This is a process of converting an existing image format (analog film) into a digital format. It does not involve analyzing biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition.
- Device Description: The device description confirms it converts analog x-ray films to digital data. This is an imaging processing task, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, reagents, assays, or any other elements typically associated with IVD devices.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is solely related to the digitization of existing medical images.
N/A
Intended Use / Indications for Use
The VIDAR Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO x-ray film digitizers are intended for producing digital copies of medical x-ray films.
Product codes
21 CFR 892.2040, 21 CFR 892.2030
Device Description
The x-ray film digitizer is an electronic device that converts analog x-ray films into digital data. The maximum film width is 14".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray films
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
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
K99 3599
'JAN 1 8 2000
510 (k) Summary As required by 807.92 For the Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO x-ray film digitizers Prepared on September 9, 1999
| Submitted by: | VIDAR Systems Corporation
460 Spring Park Place
Herndon, VA 20170
Telephone: (703) 471-7070
Fax: (703) 471-1165 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary "Pennie" Drinkard
Medical Business Line Program Manager |
| Device Trade Name: | Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO x-ray film
digitizers. |
| Common Name: | X-ray film digitizer |
| Classification: | Medical image digitizers were reviewed by the Radiology panel and are
classified in Class 11 per CFR 892.2040 (proposed). |
| Predicate Device: | MedScan 12 (K933632) |
| Manufactured by: | VIDAR Systems Corporation, 460 Spring Park Place, Herndon, VA 20170 |
| Description of Device: | The x-ray film digitizer is an electronic device that converts analog x-ray films
into digital data. The maximum film width is 14". |
Intended use for the device:
The VIDAR Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO x-ray film digitizers are intended for producing digital copies of medical x-ray films.
Substantial Equivalence to Predicate Device:
The Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO are substantially equivalent to the MedScan 12 (K933632) film digitizer manufactured by VIDAR Systems Corporation, 460 Spring Park Place, Herndon, VA 20170. Technical differences between the devices and the predicate raise no new issues of safety and effectiveness.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2000
Mary "Pennie" Drinkard Medical Business Line Program Manager Vidar Systems Corporation 460 Spring Park Place Herndon, VA 20170
Re: K993599 Diagnostic PRO, VXR-16 and VXR-16 Dosimetry PRO Dated: September 21, 1999 Received: October 25, 1999 Regulatory class: II 21 CFR 892.2030/90 LMA
Dear Ms. Drinkard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requiation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, ~ and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510 k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRYPRO.
Indications for use:
.
The Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRYPRO film digitizers are intended for making digital copies of medical x-ray films.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Sigman
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-counter Use __