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Comfort Cover

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161920

by Precision Dynamics Corporation

Identifiers

510(k) Number
K161920 FDA 510(k)
FDA Product Code
IZH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1710 FDA 510(k)
Regulation Number
892.1710 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Comfort Cover is a disposable protective barrier designed to enhance patient comfort and positioning during mammographic imaging. It serves as a soft, flexible cover that reduces pressure points and improves stability for the patient during breast compression, aiding in consistent image quality while minimizing discomfort.

This device is supplied as a single-use, non-sterile item intended for use in radiology settings, specifically within mammographic systems. It is classified as a Class II medical device under FDA regulations (892.1710) and has received a Traditional 510(k) clearance (K161920). Comfort Cover is compatible with various mammographic imaging systems as referenced in the associated predicate devices.

Frequently asked questions

What is the primary purpose of the Comfort Cover in mammographic imaging, and how does it benefit patients?

The Comfort Cover is designed to act as a disposable protective barrier that enhances patient comfort during mammographic imaging by reducing pressure points and improving stability. This soft, flexible cover minimizes discomfort during breast compression, helping to ensure consistent image quality while making the procedure more tolerable for patients.

Is the Comfort Cover intended for reuse, or is it meant to be used only once per patient?

The Comfort Cover is explicitly labeled as a single-use item, meaning it is intended for one-time use with a single patient. This design ensures hygiene and reduces the risk of cross-contamination in radiology settings.

What types of mammographic imaging systems is the Comfort Cover compatible with, and how do I verify compatibility?

The Comfort Cover is compatible with a wide range of mammographic imaging systems, as referenced in the associated predicate devices listed under the FDA 510(k) clearance (K161920). The manufacturer’s documentation should specify which systems are supported, and users can cross-reference their equipment with the listed FEI numbers (e.g., 3001722928, 3009470597) to confirm compatibility.

Is the Comfort Cover sterile, and if not, what precautions should be taken during use?

The Comfort Cover is non-sterile, so it is not intended for use in sterile procedures. However, since it is a disposable barrier, it helps maintain cleanliness by reducing direct contact between the patient and the mammographic system. Standard radiology hygiene practices, such as hand hygiene and surface disinfection, should still be followed to ensure a safe imaging environment.

How is the Comfort Cover classified under FDA regulations, and what does this mean for its use in clinical settings?

The Comfort Cover is classified as a Class II medical device under FDA regulation 892.1710, indicating it has undergone a Traditional 510(k) clearance process (K161920) to demonstrate substantial equivalence to predicate devices. This classification means it is subject to general controls and special controls specific to mammographic accessories, ensuring it meets performance and safety standards for use in radiology settings without requiring the same rigorous scrutiny as higher-risk devices.

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: Precision Dynamics Comfort Cover - allmed.wiki, Comfort Cover 510 (k) FDA Premarket Notification K161920 PRECISION ..., PDF K161920.pdf - Food and Drug Administration, Precision Dynamics - allmed.wiki, Precision-Dynamics-Corp FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Precision Dynamics Corporation

Sources (1)

  • FDA 510(k) K161920 24 fields · synced Sep 19, 2026