Hafcon (Flouro Footswitch)
by B & H Research Instruments 510(k)
Active
510(k) K901671
Overview
The Hafcon Fluoroscopic Foot Switch is a foot-controlled device designed for use with fluoroscopic imaging systems. It enables radiologic operators to activate, deactivate, or adjust fluoroscopy exposure remotely via foot pedal, enhancing ergonomic workflow and reducing hand fatigue during prolonged procedures. This device is classified as a Class II medical device under the FDA’s regulatory framework, specifically for fluoroscopic imaging applications.
The foot switch is intended for single-use or reusable settings depending on manufacturer guidelines, though no explicit sterility requirements are noted in the data. It is compatible with image-intensified fluoroscopic systems and is regulated under FDA 510(k) clearance (K901671) with a traditional review pathway. The device is supplied as a standalone accessory, with no specified MRI safety classification or storage conditions in the provided data. Authorizations are limited to the U.S. market under the regulation number 892.1650.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK901671 | Date8 Aug 1990 | 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- Withdrawn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
- JAA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Hafcon Fluoroscopic Foot Switch designed for?
The Hafcon Fluoroscopic Foot Switch is specifically designed for use with fluoroscopic imaging systems. It allows radiologic operators to remotely activate, deactivate, or adjust fluoroscopy exposure via a foot pedal, improving ergonomics and reducing hand fatigue during prolonged procedures. This is particularly useful in settings where prolonged fluoroscopy is required, such as interventional radiology or orthopedic surgeries.
Is the Hafcon Fluoroscopic Foot Switch single-use or reusable?
The Hafcon Fluoroscopic Foot Switch can be used in either single-use or reusable settings, depending on the facility’s guidelines and protocols. While no explicit sterility requirements are mentioned in the provided data, the decision to reuse should be based on institutional infection control policies and the device’s intended use. Always follow manufacturer recommendations and local regulations for proper cleaning and maintenance.
What fluoroscopic systems is the Hafcon Foot Switch compatible with?
The Hafcon Fluoroscopic Foot Switch is designed to be compatible with image-intensified fluoroscopic systems. These systems are commonly used in medical imaging to provide real-time X-ray visualization, such as during angiographic procedures, orthopedic interventions, or other fluoroscopy-guided treatments. Ensure compatibility with your specific imaging system before use.
Are there any special storage requirements for the Hafcon Foot Switch?
The provided data does not specify any special storage conditions for the Hafcon Fluoroscopic Foot Switch. However, it is generally recommended to store medical devices in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. If the device is reusable, follow manufacturer guidelines for cleaning and maintenance to ensure optimal performance and longevity.
What regulatory pathway does the Hafcon Foot Switch follow?
The Hafcon Fluoroscopic Foot Switch is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K901671. It was reviewed by the Radiology (RA) Advisory Committee and classified as a Class II medical device under the FDA’s regulatory framework for fluoroscopic imaging applications. This clearance is limited to the U.S. market under regulation number 892.1650.