Field Abutment Wedge
FDA 510(k)Class II (US FDA 510(k))
by Medtec LLC
Identifiers
- 510(k) Number
- K943343 FDA 510(k)
- FDA Product Code
- IXI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5710 FDA 510(k)
- Regulation Number
- 892.5710 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Field Abutment Wedge is a beam-shaping block used in radiation therapy. It functions to modify the radiation beam during treatment procedures.
This device is identified under FDA regulation number 892.5710 and holds FDA 510(k) clearance under K943343. It is classified as a class 2 medical device within the radiology specialty.
Frequently asked questions
What is the primary function of the Field Abutment Wedge?
The Field Abutment Wedge is a beam-shaping block utilized in radiation therapy. Its specific purpose is to modify the radiation beam during treatment procedures to ensure the beam is shaped according to clinical requirements.
What is the regulatory status of this device?
The Field Abutment Wedge is classified as a class 2 medical device under FDA regulation number 892.5710. It has received FDA 510(k) clearance under the submission number K943343, indicating it has been found substantially equivalent to legally marketed predicate devices.
Which medical specialty is this device associated with?
This device is categorized under the radiology medical specialty. It is specifically identified as a radiation therapy beam-shaping block, which is a standard component used within radiological treatment environments.
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: FIELD ABUTMENT WEDGE (K943343) — FDA 510 (k) | Innolitics, Medtec Field Abutment Wedge - allmed.wiki, PDF K943343 FIELD ABUTMENT WEDGE - 510kdatabase.net, 510 (k) K943343 — FIELD ABUTMENT WEDGE — RegDataLab, FIELD ABUTMENT WEDGE 510 (k) K943343 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K943343 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtec LLC
- FDA Applicant
- Medtec, Inc.
Sources (1)
- FDA 510(k) K943343 24 fields · synced Sep 24, 2026