Floscope Vascular Lab
by Advance Medical Device, Inc.
510(k) K905157
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905157 | Date15 Mar 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JOP
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2880
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Floscope Vascular Lab is an Ultrasonic Transducer designed for cardiovascular imaging. It functions as a diagnostic tool to visualize blood vessels, enabling assessment of vascular structures and blood flow within the circulatory system. This device supports real-time imaging, aiding in the evaluation of vascular conditions such as stenosis, aneurysms, or other abnormalities. Its classification aligns with Class II medical devices under FDA regulations, ensuring compliance with stringent performance and safety standards.
This device is supplied as a reusable component within an ultrasound system, intended for use in radiology and cardiovascular diagnostic settings. It operates in non-sterile environments but must be cleaned and maintained according to manufacturer guidelines to ensure optimal performance and infection control. The Floscope Vascular Lab is cleared under FDA 510(k) (K905157) and falls under the JOP product code, adhering to regulatory requirements for Class II devices. No MRI safety or single-use specifications are indicated in the available data.
Other devices from Advance Medical Device, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Floscope Vascular Lab used for?
The Floscope Vascular Lab is an ultrasonic transducer designed specifically for cardiovascular imaging. It enables real-time visualization of blood vessels and blood flow, helping clinicians evaluate vascular conditions such as stenosis, aneurysms, or other structural abnormalities. This makes it a critical tool in radiology and cardiovascular diagnostic settings.
Is the Floscope Vascular Lab single-use or reusable?
The Floscope Vascular Lab is a reusable component within an ultrasound system. While it is not intended for sterile environments during use, it must be thoroughly cleaned and maintained according to the manufacturer’s guidelines to ensure performance and infection control. Proper maintenance is essential for longevity and safety.
What regulatory approval does the Floscope Vascular Lab hold?
The Floscope Vascular Lab is cleared under the FDA’s 510(k) pathway with the clearance number K905157. It falls under the JOP product code and is classified as a Class II medical device, adhering to stringent regulatory requirements for cardiovascular diagnostic tools.
How should the Floscope Vascular Lab be stored?
While the Floscope Vascular Lab is not intended for sterile use, it must be stored in a clean, dry environment to prevent contamination and damage. Follow the manufacturer’s instructions for proper handling, cleaning, and maintenance to ensure optimal performance and compliance with infection control protocols.
Does the Floscope Vascular Lab have any MRI safety considerations?
The available data does not specify MRI safety features for the Floscope Vascular Lab. Clinicians should verify compatibility with their MRI systems and follow manufacturer guidelines to avoid potential risks during use in mixed environments.