OrthoScan TAU Mini C-Arm
K-Number: K183220 · 2019-06-21
ApplicantOrthoscan, Inc.
Decision Date2019-06-21
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OrthoScan TAU Mini C-Arm is a medical device manufactured by Orthoscan, Inc.. It received FDA 510(k) clearance on 2019-06-21 under approval number K183220. 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 2019-06-21. It is manufactured by Orthoscan, Inc.. The 510(k) number is K183220.
When was OrthoScan TAU Mini C-Arm approved by the FDA?
OrthoScan TAU Mini C-Arm received FDA 510(k) clearance on 2019-06-21, under approval number K183220.
What company makes OrthoScan TAU Mini C-Arm?
OrthoScan TAU Mini C-Arm is manufactured by 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.