FDA 510(k)

Idys® C ZP 3DTi

K-Number: K240715 · 2024-03-22

Decision Date2024-03-22

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Idys® C ZP 3DTi is a medical device manufactured by Clariance. It received FDA 510(k) clearance on 2024-03-22 under approval number K240715. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Idys® C ZP 3DTi?

Idys® C ZP 3DTi is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Clariance. The 510(k) number is K240715.

When was Idys® C ZP 3DTi approved by the FDA?

Idys® C ZP 3DTi received FDA 510(k) clearance on 2024-03-22, under approval number K240715.

What company makes Idys® C ZP 3DTi?

Idys® C ZP 3DTi is manufactured by Clariance.

What is the FDA product code for Idys® C ZP 3DTi?

The FDA product code for Idys® C ZP 3DTi is OVE.

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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.