Identifiers
- 510(k) Number
- K840385 FDA 510(k)
- FDA Product Code
- LMC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2040 FDA 510(k)
- Regulation Number
- 892.2040 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Video Print is a Camera, Multi Format, Radiological, designed for capturing and printing radiographic images. This device facilitates the transfer of radiographic film images to printed output, enabling archival and review in radiology settings. It operates by converting radiographic film into a visible print format, ensuring clarity and permanence for diagnostic purposes.
The Video Print is supplied as a reusable device intended for use in radiology departments. It is not classified as sterile and is not intended for MRI environments. The device is regulated under FDA 510(k) clearance (K840385) and falls under product code LMC, with a decision classification of Substantially Equivalent (SESE). Storage and maintenance follow manufacturer guidelines to ensure proper functionality and longevity.
Frequently asked questions
What is the Video Print device used for in a radiology setting?
The Video Print is designed to capture radiographic film images and convert them into printed output, allowing for archival and review purposes. This ensures that diagnostic images remain clear and permanent for further analysis by radiologists or other medical professionals.
Is the Video Print device reusable or single-use?
The Video Print is explicitly described as a reusable device, intended for long-term use in radiology departments. It is not classified as single-use, meaning it can be cleaned and maintained according to manufacturer guidelines for continued operation.
What regulatory pathway was followed for the FDA clearance of the Video Print?
The Video Print received FDA clearance through a 510(k) submission, classified as Substantially Equivalent (SESE) under product code LMC. The device was reviewed by the Radiology (RA) Advisory Committee and falls under Class II medical device regulations, with a traditional clearance process.
Can the Video Print be used in an MRI environment?
No, the Video Print is not intended for use in MRI environments. The device is designed exclusively for radiology settings where radiographic film images are processed and printed, and its materials or construction do not align with MRI-safe requirements.
How should the Video Print be stored and maintained?
The Video Print requires adherence to manufacturer guidelines for storage and maintenance to ensure proper functionality and longevity. While specific instructions are not detailed in the data, typical reusable medical devices of this nature would involve regular cleaning, calibration checks, and protection from environmental damage to sustain performance.
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: Advanced Instruments Video Print - allmed.wiki, Company | Nova Biomedical, Service and Support Overview | Advanced Instruments, ADVANCED INSTRUMENTS Manuals & User Guides - Manuals+, Advanced Instruments | Fisher Scientific
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K840385 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Instruments, Inc.
Sources (1)
- FDA 510(k) K840385 24 fields · synced Sep 20, 2026