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FDA 510(k)

Proton Positioing and Immobilization Devices

K-Number: K180021 · 2018-06-29

ApplicantMedtec Inc Dba Civco Medical Solutions and Civco Radiotherap
Decision Date2018-06-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Proton Positioing and Immobilization Devices is a medical device manufactured by Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap. It received FDA 510(k) clearance on 2018-06-29 under approval number K180021. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Proton Positioing and Immobilization Devices?

Proton Positioing and Immobilization Devices is a medical device that received FDA 510(k) clearance on 2018-06-29. It is manufactured by Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap. The 510(k) number is K180021.

When was Proton Positioing and Immobilization Devices approved by the FDA?

Proton Positioing and Immobilization Devices received FDA 510(k) clearance on 2018-06-29, under approval number K180021.

What company makes Proton Positioing and Immobilization Devices?

Proton Positioing and Immobilization Devices is manufactured by Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap.

What is the FDA product code for Proton Positioing and Immobilization Devices?

The FDA product code for Proton Positioing and Immobilization Devices is IYE.

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Related PubMed Literature

PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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