Identifiers
- 510(k) Number
- K792721 FDA 510(k)
- FDA Product Code
- IXA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1850 FDA 510(k)
- Regulation Number
- 892.1850 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Flexi-Holder is a radiographic film cassette holder designed to improve positioning accuracy during radiographic procedures. It belongs to the device type Cassette, Radiographic Film, ensuring stable and consistent film placement to enhance image quality and reduce retakes.
This device is used in radiology settings to support radiographic film cassettes, providing adjustable angles and a stable base for optimal imaging. Supplied as a reusable Class II medical device, it is authorised under FDA 510K clearance (K792721) and adheres to regulatory standards under 21 CFR 892.1850. The Flexi-Holder is intended for use with conventional radiographic film cassettes and is not MRI-compatible.
Frequently asked questions
What is the primary purpose of the Huestis Flexi-Holder in a radiology setting?
The Huestis Flexi-Holder is designed to improve positioning accuracy during radiographic procedures by providing a stable and adjustable base for radiographic film cassettes. Its adjustable angles and secure placement help enhance image quality and reduce the need for retakes, making it ideal for consistent imaging results in radiology.
Is the Flexi-Holder reusable or single-use, and how does this affect its use in clinical settings?
The Flexi-Holder is explicitly described as a reusable Class II medical device. This means it is intended for repeated use across multiple patients and procedures, which can help reduce costs and waste while maintaining hygiene protocols through proper cleaning and sterilization between uses.
What types of radiographic film cassettes can be used with the Flexi-Holder, and are there any compatibility restrictions?
The Flexi-Holder is designed to support conventional radiographic film cassettes, but it is not compatible with MRI equipment or procedures. Clinicians should ensure the cassettes used are standard radiographic types and confirm the holder’s placement does not interfere with other imaging modalities like MRI.
How is the Flexi-Holder regulated, and what does its FDA 510K clearance indicate about its safety and performance?
The Flexi-Holder holds an FDA 510K clearance (K792721) under the traditional review pathway, classified as substantially equivalent to a predicate device. This clearance indicates that the FDA has determined it meets regulatory standards for safety and effectiveness as outlined in 21 CFR 892.1850, ensuring it is suitable for use in radiology settings as intended.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Flexi-Holder Multi-Angle Film Cassette Holder Huestis Medical, Huestis Flexi-Holder - Radiation Products Design, Inc., Huestis Model FH410 Series Flexi-Holder for CR & DR Plates, Huestis Medical Flexi-Holder — FDA Class II Medical Device | MedEquip ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K792721 | Class II | Active |
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Manufacturer
- Manufacturer
- Huestis Machine Corp.
Sources (1)
- FDA 510(k) K792721 24 fields · synced Sep 19, 2026