510(k) Report

FDA applicant

Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap

Orange City, IA1 decision2018–20180 recalls

FDA records 1 decision for Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap (Orange City, IA) in 2018: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYEAccelerator, Linear, Medical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K180021Proton Positioing and Immobilization DevicesMedtec Inc Dba Civco Medical Solutions and Civco Radiotherap · 20182cite it

What has FDA decided for it lately?

  • K180021Proton Positioing and Immobilization DevicesMedtec Inc Dba Civco Medical Solutions and Civco Radiotherap · 2018

The one decision as Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap →

Other applicant names beginning “Medtec”

FDA records each applicant name separately; these may or may not be the same firm.

Medtec, Inc. 41Medtec Inc. Dba Civco Medical Solutions 2Medtec, Inc. Dba Civco Medical Solutions and Civco 1Medtec, Inc. D/B/A Civco Medical Solutions 1