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Smart Segmentation-Knowledge Based Contouring

FDA 510(k)

Class II (US FDA 510(k))

510(k) K112778

by Varian Medical Systems

Identifiers

510(k) Number
K112778 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)

Smart Segmentation-Knowledge Based Contouring is a medical device software designed to automate the contouring process in medical imaging. It enhances precision in delineating anatomical structures, particularly for radiation therapy planning, by utilizing advanced algorithms.

The device is supplied as software and is used in clinical settings for treatment planning. It is classified as a Class II medical device under FDA 510(k) clearance (K112778) with product code IYE, and is subject to special controls. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage is provided in the data.

Frequently asked questions

What is Smart Segmentation-Knowledge Based Contouring used for?

Smart Segmentation-Knowledge Based Contouring is a medical device software designed to automate the contouring process in medical imaging, enhancing precision in delineating anatomical structures for radiation therapy planning through advanced algorithms.

How is Smart Segmentation-Knowledge Based Contouring supplied and used?

The device is supplied as software and is used in clinical settings for treatment planning, specifically to assist in radiation therapy by automating anatomical contouring from medical images.

What regulatory pathway was used for Smart Segmentation-Knowledge Based Contouring?

Smart Segmentation-Knowledge Based Contouring received FDA 510(k) clearance (K112778) as a Class II medical device under product code IYE, with a determination of substantial equivalence and subject to special controls.

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: PDF Smart Segmentation Knowledge Based Contouring Instructions for Use, Smart Segmentation Knowledge Based Contouring - Varian Medical Systems ..., K133227 FDA 510(k) - SMART SEGMENTATION - KNOWLEDGE BASED CO...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Varian Medical Systems

Sources (1)

  • FDA 510(k) K112778 24 fields · synced Oct 1, 2026