VNA Optical Correlator
by Vna Systems, Inc. 510(k)
Active
510(k) K861514
Overview
The VNA Optical Correlator is a Class II medical device classified under the product code LLZ, designed as an optical correlator. This device leverages Fourier-transforming optics to compare and analyze signals, enabling applications in radiology for tasks such as target tracking and identification within imaging systems.
The VNA Optical Correlator is supplied by Vna Systems, Inc. and is intended for use in radiology settings. It is a reusable device, as indicated by its regulatory submission history, and has received FDA 510(k) clearance under K-number K861514, dated January 7, 1987. No specific sterility or MRI safety information is provided in the available data. Storage and handling instructions are not detailed beyond its regulatory classification and intended use context.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861514 | Date7 Jan 1987 | 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- Withdrawn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
Questions
What is the VNA Optical Correlator used for in radiology?
The VNA Optical Correlator is designed to compare and analyze signals using Fourier-transforming optics. This enables applications in radiology such as target tracking and identification within imaging systems, improving precision for diagnostic tasks.
Is the VNA Optical Correlator reusable or single-use?
The VNA Optical Correlator is classified as a reusable device. This determination is based on its regulatory submission history and intended use in clinical settings, where repeated applications are expected without compromising performance.
What regulatory approval does the VNA Optical Correlator hold?
The VNA Optical Correlator holds FDA 510(k) clearance under the K-number K861514, granted on January 7, 1987. This clearance confirms its substantial equivalence to a predicate device under the product code LLZ, specifically for radiology applications.
Are there any specific sterility or MRI safety requirements for the VNA Optical Correlator?
The available data does not provide explicit details regarding sterility or MRI safety for the VNA Optical Correlator. Users should follow standard radiology protocols and consult manufacturer guidelines to ensure safe and compliant operation in their specific clinical environment.
How should the VNA Optical Correlator be stored and handled?
While specific storage and handling instructions are not detailed beyond its regulatory classification and intended use, the device is designed for reusable applications in radiology. It should be stored in a clean, controlled environment to prevent contamination or damage, adhering to general medical device maintenance practices.