Konica Laser Imager LI-21
510(k) K950359
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK950359 | Date6 Sep 1995 | 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- Withdrawn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, 19 Sep 2026
The Konica Laser Imager LI-21 is a Camera, Multi Format, Radiological, designed for processing and enhancing radiographic images. It converts conventional X-ray film into digital or printed formats, supporting multiple film sizes and formats to improve diagnostic clarity and workflow efficiency in radiology settings.
This device is supplied as a standalone imaging accessory, intended for use in radiology departments. It operates in a non-sterile environment and is classified as a Class II medical device under FDA regulation 892.2040. The imager is reusable and requires proper calibration and maintenance to ensure accurate image reproduction. Authorized under FDA 510(k) clearance K950359, it adheres to radiology-specific standards for image quality and safety.
Other devices from Storch Amini & Munves PC
Questions
AI-generated answers, 19 Sep 2026
What types of radiographic film sizes and formats does the Konica Laser Imager LI-21 support for processing and enhancement?
The Konica Laser Imager LI-21 is designed to handle multiple radiographic film sizes and formats, as indicated by its classification as a 'Camera, Multi Format, Radiological.' The device supports a variety of film types commonly used in radiology, ensuring flexibility for different diagnostic imaging needs. This versatility helps improve workflow efficiency by accommodating standard and non-standard film sizes in a single system.
Is the Konica Laser Imager LI-21 intended for sterile use, or is it meant for non-sterile environments like radiology departments?
The Konica Laser Imager LI-21 is explicitly described as a device intended for use in a non-sterile environment, such as radiology departments. Since it processes and enhances radiographic images rather than interacting directly with patients or sterile procedures, it does not require sterile conditions. This classification aligns with its role as a standalone imaging accessory.
How is the Konica Laser Imager LI-21 supplied, and is it a single-use or reusable device?
The Konica Laser Imager LI-21 is supplied as a standalone imaging accessory and is designed for reuse in radiology settings. Unlike disposable medical devices, this imager requires proper calibration and maintenance to ensure consistent image quality and accuracy over time. Its reusable nature makes it cost-effective for long-term use in clinical environments.
What regulatory pathway was followed for the FDA clearance of the Konica Laser Imager LI-21, and what does this mean for its use?
The Konica Laser Imager LI-21 received FDA clearance through a Traditional 510(k) pathway, classified as substantially equivalent (SESE) under the Radiology advisory committee (RA). This means the device was determined to be as safe and effective as a legally marketed predicate device, adhering to FDA regulations for Class II radiological cameras. Clinicians can rely on its compliance with radiology-specific standards for image quality and safety.