Coronis Fusion 6MP DL, Model: MDCC 6130 DL
by Barcoview, Medical Imaging Systems 510(k)
Active
510(k) K073007
Overview
The Coronis Fusion 6MP DL, Model: MDCC 6130 DL is a 6 MegaPixel wide-screen diagnostic color display system. It is a pathology display system designed to enhance flexibility and productivity in pathology imaging.
The device received FDA 510(k) clearance (K073007) on February 14, 2008, as substantially equivalent to a predicate device. It is manufactured by Barcoview, Medical Imaging Systems in Kortrijk, Belgium.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073007 | Date14 Feb 2008 | 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- Withdrawn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
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Barcoview, Medical Imaging Systems
Questions
What is the Coronis Fusion 6MP DL used for?
The Coronis Fusion 6MP DL is a pathology display system designed to enhance flexibility and productivity in pathology imaging, providing a 6 MegaPixel wide-screen diagnostic color display for viewing medical images.
How is the Coronis Fusion 6MP DL supplied and what are its key specifications?
The device is supplied as a complete diagnostic color display system with model number MDCC 6130 DL, featuring a 6 MegaPixel wide-screen display, manufactured by Barcoview in Kortrijk, Belgium, and received FDA 510(k) clearance K073007 on February 14, 2008.
Is the Coronis Fusion 6MP DL intended for single-use or reuse?
As a diagnostic display system, the Coronis Fusion 6MP DL is designed for reuse in clinical environments, consistent with its role as a medical imaging display for ongoing pathology workflows rather than a single-use disposable device.