(296 days)
NOT AVAILABLE
Not Found
No
The description focuses on hardware (CCD sensor, film feeder) and standard protocols (DICOM, FTP, TCP/IP) for digitizing and transferring images. There is no mention of AI, ML, or advanced image processing beyond basic digitization.
No.
The device's intended use is to digitize medical images from x-ray film, which is a diagnostic function, not a therapeutic one.
No
The device digitizes medical images from x-ray film. It does not analyze or interpret these images to provide a diagnosis. Its function is to convert analog film to digital data.
No
The device description explicitly states it is a "desktop size x-ray film digitizing system with CCD linear sensor," 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 "digitize medical images from x-ray film." This is a process of converting physical images into digital format.
- Device Description: The description focuses on the hardware (scanner, sensor, feeder) and data transfer protocols (DICOM, FTP).
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing diagnostic information based on the analysis of biological samples.
- Measuring or detecting substances in biological samples.
The device's function is to create digital representations of existing medical images (x-rays), which are then typically used by healthcare professionals for diagnosis or other medical purposes. The device itself does not perform any diagnostic testing on biological materials.
N/A
Intended Use / Indications for Use
Both devices are designed to digitize medical images from x-ray film.
Product codes
Not Found
Device Description
The Canon Film Scanner is a desktop size x-ray film digitizing system with CCD linear sensor. Features high throughput due to high speed scan and automatic film feeder with 100 sheet capacity. DICOM and FTP protocol on TCP/IP are supported.
Mentions image processing
Digitize medical images from x-ray film.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests: Software evaluation is being performed to show substantial equivalence.
Clinical Tests: N/A
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.
NOT AVAILABLE
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
510(k) Summary (mcdified)
Prepared:
March 29, 1996
Submitter:
| Company Name: | Canon USA, Inc. |
|---|---|
| Company Address: | One Canon Plaza |
| Lake Success, NY 11042 | |
| Contact Person: | Glenn Impal, Manager |
| Phone Number: | (516) 328-5605 |
| Fax Number: | (516) 328-5169 |
Device:
| Reason For 510(k): | New Model |
|---|---|
| Manufacturer: | Canon Inc. |
| Trade Name: | Canon |
| Model Name: | Film Scanner 300 |
| Classification Name: | Image Digitizer |
| FDA 510(k) #: | K960839 |
Substantial Equivalent Device:
| Manufacturer: | Vidar |
|---|---|
| Trade Name: | Vidar |
| Model Name: | VXR-12 |
| Classification Name: | Image Digitizer |
| FDA 510(k) #: | NOT AVAILABLE |
Description Of Device:
The Canon Film Scanner is a desktop size x-ray film digitizing system with CCD linear sensor. Features high throughput due to high speed scan and automatic film feeder with 100 sheet capacity. DICOM and FTP protocol on TCP/IP are supported.
Intended Use:
Both devices are designed to digitize medical images from x-ray film.
Technical Characteristics:
Please refer to the attached COMPARISON CHART.
Non-clinical Tests:
Software evaluation is being performed to show substantial equivalence.
Clinical Tests:
N/A
Conclusions:
Please wait for the completed software evaluation report to be submitted under separate cover.
DEC 1 8 1996