Lasernet Image Manager/Print Server
by Frantz Imaging, Inc. 510(k)
Active
510(k) K952485
Overview
The Lasernet Image Manager/Print Server is a radiological digitizer classified under the FDA’s product code LMA. This device is designed to manage and print digital radiological images, facilitating workflow integration in radiology departments by enabling the transfer, storage, and printing of diagnostic imaging data from various modalities. It serves as a central hub for image processing, ensuring compatibility with existing radiology systems and enhancing efficiency in image distribution.
This device is supplied as a reusable Class II medical device, intended for use in radiology settings. It operates in non-sterile environments and does not require single-use disposal. The system is regulated under FDA 510(k) clearance (K952485) and falls under the regulatory framework for radiological digitizers, adhering to the requirements outlined in 21 CFR 892.2030. No MRI safety or sterility classifications are specified, and its operation relies on standard electrical and network connectivity within clinical environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952485 | Date24 Nov 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LMA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2030
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Frantz Imaging, Inc.
Questions
What is the Lasernet Image Manager/Print Server used for?
The Lasernet Image Manager/Print Server is designed to manage, transfer, store, and print digital radiological images from various imaging modalities. It acts as a central hub in radiology departments, ensuring compatibility with existing systems to improve workflow efficiency and image distribution.
Is the Lasernet Image Manager/Print Server a single-use or reusable device?
This device is classified as a reusable Class II medical device. It is intended for repeated use in radiology settings and does not require single-use disposal, making it cost-effective for long-term clinical operations.
Does the Lasernet Image Manager/Print Server require sterile conditions for operation?
No, the Lasernet Image Manager/Print Server is intended for use in non-sterile environments. Sterility is not a requirement for its operation, as it functions as a digital processing and printing system rather than a sterile medical instrument.
What regulatory pathway does the Lasernet Image Manager/Print Server follow?
The device follows the FDA’s 510(k) clearance pathway, specifically under product code LMA for radiological digitizers. It was granted clearance (K952485) in 1995 and adheres to the regulatory requirements outlined in 21 CFR 892.2030, ensuring compliance with radiological imaging standards.
How does the Lasernet Image Manager/Print Server integrate with existing radiology systems?
The device is engineered to integrate seamlessly with existing radiology systems by enabling the transfer, storage, and printing of diagnostic imaging data. Its design ensures compatibility with various imaging modalities, reducing manual intervention and enhancing overall workflow efficiency in clinical environments.