(151 days)
There are no reference devices mentioned in the provided text.
No
The device description focuses on the hardware components and basic digitization process, with no mention of AI, ML, or advanced image processing that would typically indicate such technology.
No
The device is a film digitizer, intended for creating digital copies of x-ray films, not for diagnosing, treating, or preventing disease.
No
The device digitizes medical x-ray films but does not provide diagnostic information or analysis of the images. Its intended use is to produce digital copies of films, not to diagnose patients.
No
The device description explicitly details hardware components such as a laser beam, mechanical stage, light collector, photomultiplier, and electronic circuitry, indicating it is a physical device, not software-only.
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 existing images into a digital format, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The description details the technical components for scanning and digitizing film. It doesn't mention any reagents, assays, or procedures for analyzing biological specimens.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases based on biological markers.
The device is a film digitizer, which is a tool for managing and viewing medical images, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Vidar VXR-LS Film Digitizer is intended for producing digital copies of medical x-ray films.
Product codes
90 LMA
Device Description
The Vidar VXR-LS is a digitizer of radiographic film transparencies incorporating a laser beam scanned in one direction, a mechanical stage that moves a sheet of film in the orthogonal direction, a light collector and photomultiplier and electronic circuity for analog-to-digital conversion, system operation, and connection to external networks.
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)
K934496 Lumiscan 75
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