3M Color Medical Flat Panel Display, CCL316
510(k) K032555
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032555 | Date26 Feb 2004 | 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- Withdrawn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
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The 3M Color Medical Flat Panel Display, CCL316 is a visual display unit for medical images within a PACS environment. It functions to display diagnostic images for clinical interpretation and decision-making by physicians in clinical settings. The device receives video signals from a workstation to present medical images.
This Class II X-ray system is manufactured by Totoku Electric Co., Ltd. and has received FDA 510(k) clearance with the number K032555. It is intended for use in radiology departments and is regulated under product code LLZ. The device was received by the FDA on 2003-08-19 and cleared as substantially equivalent on 2004-02-26.
Other devices from Totoku Electric Co., Ltd.
Questions
AI-generated answers, 22 Sep 2026
What is the 3M Color Medical Flat Panel Display CCL316 used for?
The CCL316 is a visual display unit designed for medical images within a PACS environment. It displays diagnostic images for clinical interpretation and decision-making by physicians in clinical settings, particularly in radiology departments.
What are the regulatory approvals for this medical display?
The 3M Color Medical Flat Panel Display CCL316 has received FDA 510(k) clearance with number K032555. It was received by the FDA on 2003-08-19 and cleared as substantially equivalent on 2004-02-26. It is regulated under product code LLZ.
How is the CCL316 medical display supplied and what are its specifications?
The device is supplied as a visual display unit that functions to present medical images. It receives video signals from a workstation to display diagnostic images. The specific technical measurements and configurations are not detailed in the provided information.
Is the CCL316 display reusable or single-use?
The device is a display unit intended for repeated use in clinical settings. As a Class II X-ray system, it is designed to be a permanent fixture in medical environments for displaying diagnostic images over time.