Orthoscan TAU Mini C-Arm
K-Number: K250587 · 2025-07-02
ApplicantZiehm-Orthoscan, Inc.
Decision Date2025-07-02
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Orthoscan TAU Mini C-Arm is a medical device manufactured by Ziehm-Orthoscan, Inc.. It received FDA 510(k) clearance on 2025-07-02 under approval number K250587. 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 TAU Mini C-Arm?
Orthoscan TAU Mini C-Arm is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Ziehm-Orthoscan, Inc.. The 510(k) number is K250587.
When was Orthoscan TAU Mini C-Arm approved by the FDA?
Orthoscan TAU Mini C-Arm received FDA 510(k) clearance on 2025-07-02, under approval number K250587.
What company makes Orthoscan TAU Mini C-Arm?
Orthoscan TAU Mini C-Arm is manufactured by Ziehm-Orthoscan, Inc..
What is the FDA product code for Orthoscan TAU Mini C-Arm?
The FDA product code for Orthoscan TAU Mini C-Arm is OXO.
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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.