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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap. It received FDA 510(k) clearance on 2018-06-29 under 510(k) 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. The listed applicant is Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap. The 510(k) number is K180021.

When did Proton Positioing and Immobilization Devices receive FDA 510(k) clearance?

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

Who is the listed applicant for Proton Positioing and Immobilization Devices?

The FDA 510(k) record lists Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

Official Source

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

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