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Proton Positioing and Immobilization Devices

by Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap

510(k) K180021

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180021 Date29 Jun 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Proton Positioning and Immobilization Devices are medical devices classified as Accelerator, Linear, Medical under product code IYE. They are designed for use in radiology applications to position and immobilize patients during proton therapy procedures.

These devices received FDA 510(k) clearance (K180021) on June 29, 2018, as substantially equivalent to a predicate device. They are Class II medical devices subject to special controls and were submitted by Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap located in Orange City, Iowa, United States.

Other devices from Medtec, Inc. Dba Civco Medical Solutions and Civco

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of Proton Positioning and Immobilization Devices?

    These devices are designed for use in radiology applications to position and immobilize patients during proton therapy procedures, ensuring accurate and consistent patient alignment for treatment delivery.

  • What regulatory pathway was used for Proton Positioning and Immobilization Devices?

    The devices received FDA 510(k) clearance (K180021) on June 29, 2018, as substantially equivalent to a predicate device, following the traditional 510(k) submission process for Class II medical devices.

  • What is the product code and device classification for Proton Positioning and Immobilization Devices?

    The product code is IYE, and the device is classified as an Accelerator, Linear, Medical device under FDA regulations, placing it in Class II with special controls.

  • Who is the manufacturer of Proton Positioning and Immobilization Devices and where are they located?

    The manufacturer is Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap, located at 140 8th St. SE, Orange City, Iowa, 51041, United States.