Fluoro Plus
by Advantage Medical Systems, Inc.
510(k) K861279
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861279 | Date16 Jun 1986 | 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- Withdrawn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, 25 Sep 2026
The Fluoro Plus is a radiological image processing system designed for use in medical imaging applications. It functions as an X-ray system to facilitate diagnostic procedures within a clinical radiology setting.
This device is classified as a Class II medical device under the LLZ product code. It received FDA 510(k) clearance on June 16, 1986, under submission number K861279. The system is manufactured by Advantage Medical Systems, Inc.
Other devices from Advantage Medical Systems, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the primary function of the Fluoro Plus system?
The Fluoro Plus is a radiological image processing system designed to function as an X-ray system. It is intended to facilitate diagnostic procedures specifically within a clinical radiology environment.
What is the regulatory status of the Fluoro Plus?
The Fluoro Plus is a Class II medical device that received FDA 510(k) clearance on June 16, 1986, under submission number K861279. It was determined to be substantially equivalent to existing devices at the time of its review.
Which medical specialty is this device intended for?
The device is intended for use within the field of radiology. This is reflected in its classification under the Radiology advisory committee and its designation for diagnostic imaging applications.