MoldCare Head & Neck Cushion, Model MT-ACL-14242
FDA 510(k)Class II (US FDA 510(k))
by Medtec LLC
Identifiers
- 510(k) Number
- K982624 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MoldCare Head & Neck Cushion (Model MT-ACL-14242) is a patient positioning accessory designed to conform to the back of a patient’s head. It stabilizes the head and neck during radiation therapy or other clinical treatments, reducing movement and improving repeatable positioning accuracy.
This device is intended for use in conjunction with radiographic head holder systems and is classified as a Class II medical device under FDA regulations. It is supplied as a reusable accessory and requires proper cleaning and maintenance to ensure sterility and functionality. The MoldCare Head & Neck Cushion holds an FDA 510(k) clearance (K982624) for substantial equivalence in radiology applications.
Frequently asked questions
What is the primary purpose of the MoldCare Head & Neck Cushion in clinical settings?
The MoldCare Head & Neck Cushion (Model MT-ACL-14242) is designed to stabilize a patient’s head and neck during radiation therapy or other clinical treatments. By conforming to the back of the patient’s head, it reduces movement and improves the accuracy of repeatable positioning, which is critical for precise treatment delivery.
How is the MoldCare Head & Neck Cushion supplied, and what maintenance is required?
The MoldCare Head & Neck Cushion is supplied as a reusable accessory. Since it is not single-use, proper cleaning and maintenance are essential to ensure sterility and functionality. Users must follow manufacturer guidelines to maintain its performance over time.
Is the MoldCare Head & Neck Cushion compatible with specific radiographic systems?
Yes, the MoldCare Head & Neck Cushion is intended for use in conjunction with radiographic head holder systems. Its FDA clearance (K982624) specifically references substantial equivalence in radiology applications, confirming compatibility with linear accelerators and other relevant imaging or treatment devices.
What regulatory pathway was followed for FDA clearance of this device?
The MoldCare Head & Neck Cushion received FDA clearance through a traditional 510(k) pathway, classified as a Class II medical device. The submission was reviewed by the Radiology (RA) Advisory Committee, and the clearance (K982624) was granted on October 26, 1998, for substantial equivalence in radiology applications.
How does the MoldCare Head & Neck Cushion ensure consistent positioning for patients?
The cushion’s design allows it to conform to the natural curvature of a patient’s head and neck, providing a stable and repeatable positioning solution. This reduces unintended movement during treatments like radiation therapy, which is vital for maintaining treatment precision and minimizing exposure variability.
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: MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 by MED-TEC,INC ..., Moldcare Head & Neck Cushion, Model # Mt-acl-14242, K982624 - Moldcare Head & Neck Cushion, Model # Mt-acl-14242
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982624 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtec LLC
- FDA Applicant
- Med-Tec,Inc.
Sources (1)
- FDA 510(k) K982624 24 fields · synced Sep 19, 2026