FDA 510(k)

Orthoscan VERSA Mini C-Arm

K-Number: K243452 · 2025-01-14

Decision Date2025-01-14

Product CodeOXO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Orthoscan VERSA Mini C-Arm is a medical device manufactured by Ziehm-Orthoscan, Inc.. It received FDA 510(k) clearance on 2025-01-14 under approval number K243452. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orthoscan VERSA Mini C-Arm?

Orthoscan VERSA Mini C-Arm is a medical device that received FDA 510(k) clearance on 2025-01-14. It is manufactured by Ziehm-Orthoscan, Inc.. The 510(k) number is K243452.

When was Orthoscan VERSA Mini C-Arm approved by the FDA?

Orthoscan VERSA Mini C-Arm received FDA 510(k) clearance on 2025-01-14, under approval number K243452.

What company makes Orthoscan VERSA Mini C-Arm?

Orthoscan VERSA Mini C-Arm is manufactured by Ziehm-Orthoscan, Inc..

What is the FDA product code for Orthoscan VERSA Mini C-Arm?

The FDA product code for Orthoscan VERSA Mini C-Arm is OXO.

Other Devices by Ziehm-Orthoscan, Inc.

K250587Orthoscan TAU Mini C-Arm K252579Orthoscan TAU MVP Mini C-Arm System

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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.