Identifiers
- 510(k) Number
- K901567 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 Huestis Compu-Plotter is a radiation therapy beam-shaping block device. It is designed to assist in the creation of radiation therapy blocks used in clinical radiology applications.
This device is classified as a Class II medical device under regulation number 892.5710. It received FDA 510(k) clearance under K901567 on May 31, 1990.
Frequently asked questions
What is the primary function of the Huestis Compu-Plotter?
The Huestis Compu-Plotter is a specialized device used in clinical radiology to assist in the creation of radiation therapy beam-shaping blocks. These blocks are essential for tailoring radiation delivery during patient treatment.
What is the regulatory status of this device?
The Huestis Compu-Plotter is a Class II medical device regulated under 892.5710. It received FDA 510(k) clearance on May 31, 1990, under submission number K901567, confirming it was found to be substantially equivalent to existing devices.
Which medical specialty uses the Huestis Compu-Plotter?
This device is categorized under the radiology medical specialty. It is specifically designed for use in radiation therapy applications where precise beam-shaping is required for clinical procedures.
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: Huestis Home Page, Huestis Machine The Compu-Plotter - allmed.wiki, THE HUESTIS COMPU-PLOTTER (K901567) — FDA 510(k) | Innolitics, Huestis Machine Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K901567 | Class II | Active |
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Manufacturer
- Manufacturer
- Huestis Machine Corp.
Sources (1)
- FDA 510(k) K901567 24 fields · synced Sep 21, 2026