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SOFTDISO

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170345

by Best Nomos

Identifiers

510(k) Number
K170345 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)

SOFTDISO is a stand-alone, user-friendly, workflow-driven application that performs In-Vivo dosimetric analysis for 3DCRT, IMRT and VMAT beams using aSi-EPID portal systems. It checks the correctness of treatment by comparing the planned dose from a treatment planning system with the applied dose measured from EPID during treatment.

SOFTDISO is a Class II medical device manufactured by Best Nomos. It is supplied as a stand-alone application and is intended for use with aSi-EPID portal systems. The device has received FDA 510(k) clearance with the product code IYE and is regulated under 892.5050.

Frequently asked questions

What is SOFTDISO used for?

SOFTDISO is a stand-alone application that performs in-vivo dosimetric analysis for 3DCRT, IMRT and VMAT beams using aSi-EPID portal systems. It verifies treatment accuracy by comparing planned dose with measured dose during treatment.

How is SOFTDISO supplied?

SOFTDISO is supplied as a stand-alone application intended for use with aSi-EPID portal systems. It is a Class II medical device manufactured by Best Nomos and requires compatible EPID systems for operation.

What regulatory approvals does SOFTDISO have?

SOFTDISO has received FDA 510(k) clearance with product code IYE and is regulated under 892.5050. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.

What beam types does SOFTDISO support?

SOFTDISO supports in-vivo dosimetric analysis for three types of radiation beams: 3DCRT (3D conformal radiation therapy), IMRT (intensity-modulated radiation therapy), and VMAT (volumetric modulated arc therapy).

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 Best SOFTDISO In-Vivo Dose Verification System - NOMOS, Best NOMOS Products, Best NOMOS, Best Nomos Softdiso - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Best Nomos

Sources (1)

  • FDA 510(k) K170345 24 fields · synced Sep 27, 2026