Identifiers
- 510(k) Number
- K860193 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 Portalcast is a beam-shaping block used in radiation therapy. It functions as equipment for lead casting and foam block cutting within radiology applications.
This device is classified as a Class II medical device under regulation number 892.5710. It has received FDA 510(k) clearance under K860193.
Frequently asked questions
What is the primary function of the Portalcast device?
The Portalcast is a beam-shaping block used in radiation therapy. It is specifically designed to function as equipment for lead casting and foam block cutting within radiology clinical applications.
How is the Portalcast classified for regulatory purposes?
The Portalcast is classified as a Class II medical device under regulation number 892.5710. It has received FDA 510(k) clearance under submission number K860193.
What is the product code for the Portalcast?
The Portalcast is identified by the product code IXI, which corresponds to its classification as a radiation therapy beam-shaping block within the radiology medical specialty.
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: Diacor Portalcast - allmed.wiki, PORTALCAST Trademark - Registration Number 1422708 - Serial Number ..., PORTALCAST Trademark | Trademarkia, PORTALCAST 510 (k) K860193 - FDA.report, Portalcast Trademark - Diacor, Inc. - Salt Lake City, UT - Bizapedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K860193 | Class II | Active |
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Manufacturer
- Manufacturer
- Diacor Inc.
- FDA Applicant
- Diacor, Inc.
Sources (1)
- FDA 510(k) K860193 24 fields · synced Sep 27, 2026