Kostec Medical Grade Ldc Monitors
by Kostec Co., Ltd. 510(k)
Active
510(k) K123944
Overview
Kostec Medical Grade Ldc Monitors are radiological image processing systems intended for use in radiology. The device is classified under product code LLZ and is designed for processing and displaying medical images.
The device is supplied as a reusable system and received FDA 510(k) clearance (K123944) on September 5, 2013, as substantially equivalent to a predicate device. It is intended for use in radiological imaging environments and operates under the regulatory classification of a Class II medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123944 | Date5 Sep 2013 | 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- Withdrawn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 Kostec Co., Ltd.
Questions
What is the Kostec Medical Grade Ldc Monitor used for?
The Kostec Medical Grade Ldc Monitor is a radiological image processing system intended for processing and displaying medical images in radiology environments, as specified in its FDA 510(k) submission.
Is the Kostec Medical Grade Ldc Monitor reusable or single-use?
The device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance, not for single-use disposal.
What regulatory clearance does the Kostec Medical Grade Ldc Monitor have?
The device received FDA 510(k) clearance (K123944) on September 5, 2013, as substantially equivalent to a predicate device, and is classified as a Class II medical device under product code LLZ.