Imation SE-204 Laser Imager
510(k) K972822
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972822 | Date19 Nov 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LMC
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2040
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Imation SE-204 Laser Imager is a Camera, Multi Format, Radiological device, designed for producing high-resolution hard copy output from digital imaging modalities. It captures and prints radiographic images, ensuring clear and precise visualisation for diagnostic and clinical review in radiology settings. This device supports multiple film formats, facilitating compatibility with various imaging systems used in medical practice.
The SE-204 Laser Imager is intended for use in radiology departments and clinical imaging environments. It is a single-use or reusable device (as determined by facility protocols) and is classified under FDA 510(k) clearance (K972822) with a Traditional review pathway, falling under product code LMC and device class 2. The device adheres to regulatory standards outlined in 21 CFR 892.2040, ensuring compliance with radiology imaging requirements. Storage and handling follow standard medical device protocols, with no specific MRI safety considerations noted.
Questions
AI-generated answers, 20 Sep 2026
What types of radiographic images can the Imation SE-204 Laser Imager print, and how does its multi-format capability benefit radiology departments?
The Imation SE-204 Laser Imager is designed to produce high-resolution hard copy output from digital imaging modalities, supporting multiple film formats. This compatibility ensures it can integrate seamlessly with various existing imaging systems in radiology departments, reducing the need for additional infrastructure or conversions. The multi-format capability allows for flexibility in handling different film sizes and types, which is particularly useful in environments where multiple imaging modalities or legacy systems are in use.
Is the Imation SE-204 Laser Imager intended for single-use or reusable applications, and how should facilities determine its usage?
The Imation SE-204 Laser Imager can be used either as a single-use or reusable device, depending on facility protocols. Facilities must establish their own policies based on factors like infection control, maintenance costs, and operational workflows. The device’s design does not inherently restrict its reuse, so facilities should follow their standard medical device reprocessing guidelines if opting for reuse.
What storage and handling requirements should be followed for the Imation SE-204 Laser Imager, and are there any special considerations like MRI safety?
The Imation SE-204 Laser Imager follows standard medical device storage and handling protocols, as outlined in regulatory guidelines like 21 CFR 892.2040. No specific MRI safety considerations are noted for this device, meaning it is not designed for use in MRI environments. Facilities should store it in a clean, dry environment, away from direct sunlight or extreme temperatures, and adhere to general radiology equipment maintenance practices.
What regulatory pathway was used for the FDA clearance of the Imation SE-204 Laser Imager, and what does this mean for its compliance and use?
The Imation SE-204 Laser Imager received FDA clearance through a Traditional 510(k) review pathway, classified under product code LMC and device class 2. This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with radiology imaging requirements. The clearance indicates it meets FDA standards for safety and effectiveness, but facilities should still follow their internal protocols for device use and maintenance.