Kodak Medical Imager 300
by Eastman Kodak Company 510(k)
Active
510(k) K042158
Overview
The Kodak Medical Imager 300 is a Camera, Multi Format, Radiological device, designed for capturing and processing radiographic images. It functions by converting electronic image signals into thermal outputs to develop Kodak imaging media, enabling high-quality radiographic imaging for diagnostic purposes in radiology settings. This system supports multiple imaging formats, facilitating versatile use in clinical environments.
The device is supplied as a reusable medical imaging system, intended for use in radiology departments. It is classified as a Class II device under FDA regulations (product code LMC), with clearance through the Traditional 510(k) pathway. The system requires proper maintenance and calibration to ensure accurate image development and diagnostic reliability. Storage and handling must comply with manufacturer guidelines to preserve functionality and sterility where applicable.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042158 | Date24 Sep 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Eastman Kodak Company
Questions
What is the Kodak Medical Imager 300 used for?
The Kodak Medical Imager 300 is a reusable multi-format radiological camera designed specifically for capturing and processing radiographic images. It converts electronic image signals into thermal outputs to develop Kodak imaging media, ensuring high-quality diagnostic imaging in radiology settings. This versatility makes it suitable for a range of clinical environments where precise and reliable radiographic results are required.
How is the Kodak Medical Imager 300 supplied and maintained?
The Kodak Medical Imager 300 is supplied as a reusable system intended for use in radiology departments. To ensure accurate image development and diagnostic reliability, it requires regular maintenance and calibration as outlined in the manufacturer’s guidelines. Proper upkeep is essential to preserve functionality and maintain the system’s performance over time.
Is the Kodak Medical Imager 300 single-use or reusable?
The Kodak Medical Imager 300 is a reusable medical imaging system. Unlike single-use devices, it is designed for repeated use in clinical settings, provided it undergoes proper maintenance, calibration, and storage as specified by the manufacturer. This design supports cost-effective and sustainable operations in radiology departments.
What regulatory pathway was followed for the Kodak Medical Imager 300?
The Kodak Medical Imager 300 was cleared through the Traditional 510(k) pathway by the FDA, classified as a Class II device under product code LMC. This pathway confirms that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in radiological imaging applications.
What storage and handling guidelines should be followed for the Kodak Medical Imager 300?
Storage and handling of the Kodak Medical Imager 300 must comply with the manufacturer’s guidelines to preserve its functionality and ensure optimal performance. Proper storage conditions, including protection from environmental factors like moisture and temperature fluctuations, are critical. Additionally, adherence to sterility protocols—where applicable—helps maintain the device’s reliability for diagnostic imaging purposes.