Identifiers
- 510(k) Number
- K130406 FDA 510(k)
- FDA Product Code
- LMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2030 FDA 510(k)
- Regulation Number
- 892.2030 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DiagnosticPRO Edge Film Digitizer is a radiological image digitizer designed to convert analog radiographic films into digital images. Classified as a radiological digitizer under the nomenclature authority, it facilitates the transition from film-based to digital radiology workflows by capturing high-resolution scans of X-ray films for further analysis and storage.
This device is intended for use in radiology settings and is supplied as a reusable, non-sterile medical instrument. It operates with compatible Windows operating systems (32-bit and 64-bit) and requires specific power adapters for certain serial number ranges (e.g., serial numbers 380,000–389,999 use Vidar part number 40). The device holds an FDA 510(k) clearance under the Radiology Advisory Committee, classified as a Class II medical device (K130406).
Frequently asked questions
What types of X-ray films can the DiagnosticPRO Edge Film Digitizer process, and how does it improve radiology workflows?
The DiagnosticPRO Edge Film Digitizer is designed to convert analog radiographic films into high-resolution digital images, enabling seamless integration into digital radiology workflows. It is specifically intended for use in radiology settings to replace film-based systems by capturing detailed scans of X-ray films, which can then be analyzed, stored, and shared electronically. This transition helps streamline workflows, reduce physical storage needs, and improve accessibility of patient imaging data.
Is the DiagnosticPRO Edge Film Digitizer reusable or single-use, and what does that mean for maintenance and cleaning?
The DiagnosticPRO Edge Film Digitizer is a reusable, non-sterile medical instrument. As a reusable device, it requires regular cleaning and maintenance to ensure consistent performance and hygiene. Users should follow manufacturer guidelines for cleaning protocols to prevent contamination and extend the device’s lifespan, as it is not intended for single-use.
What operating system compatibility and power requirements should I consider when purchasing or using the DiagnosticPRO Edge Film Digitizer?
The DiagnosticPRO Edge Film Digitizer is compatible with both 32-bit and 64-bit versions of Windows operating systems. Additionally, certain serial number ranges (e.g., serial numbers 380,000–389,999) require a specific power adapter, such as Vidar part number 40. Always verify the serial number and consult the manufacturer’s documentation to ensure the correct power adapter is used.
How do I determine if my DiagnosticPRO Edge Film Digitizer requires a specific power adapter, and where can I find the correct part number?
The power adapter requirement depends on the device’s serial number. For example, serial numbers between 380,000 and 389,999 require Vidar part number 40. To confirm the correct adapter, check the serial number label on the device and cross-reference it with Vidar Systems Corp.’s documentation or support resources. If unsure, contacting Vidar’s technical support can provide clarification.
What regulatory pathway was followed for the FDA clearance of the DiagnosticPRO Edge Film Digitizer, and what does that mean for its classification?
The DiagnosticPRO Edge Film Digitizer received FDA clearance through a 510(k) submission, specifically under the Radiology Advisory Committee (RA). It was classified as a Class II medical device and determined to be substantially equivalent to a predicate device. This clearance indicates that the device meets FDA standards for safety and effectiveness in its intended use as a radiological digitizer, though it does not imply approval for any specific clinical indication.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF 19617-001 Guide, DiagnosticPRO Edge Use - 3dsystems.com, VIDAR DIAGNOSTICPRO EDGE USER MANUAL Pdf Download, Vidar DiagnosticPRO Edge Manuals | ManualsLib, PDF 19616-001 Guide, DiagnosticPRO Edge Installation, DiagnosticPRO Edge User Guide | Manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130406 | Class II | Active |
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Manufacturer
- Manufacturer
- Vidar Systems Corp.
Sources (1)
- FDA 510(k) K130406 24 fields · synced Sep 19, 2026