TeraRecon Aorta.CT (1.1.0)
K-Number: K243158 · 2025-01-23
ApplicantTerarecon,Inc.
Decision Date2025-01-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TeraRecon Aorta.CT (1.1.0) is a medical device manufactured by Terarecon,Inc.. It received FDA 510(k) clearance on 2025-01-23 under approval number K243158. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TeraRecon Aorta.CT (1.1.0)?
TeraRecon Aorta.CT (1.1.0) is a medical device that received FDA 510(k) clearance on 2025-01-23. It is manufactured by Terarecon,Inc.. The 510(k) number is K243158.
When was TeraRecon Aorta.CT (1.1.0) approved by the FDA?
TeraRecon Aorta.CT (1.1.0) received FDA 510(k) clearance on 2025-01-23, under approval number K243158.
What company makes TeraRecon Aorta.CT (1.1.0)?
TeraRecon Aorta.CT (1.1.0) is manufactured by Terarecon,Inc..
What is the FDA product code for TeraRecon Aorta.CT (1.1.0)?
The FDA product code for TeraRecon Aorta.CT (1.1.0) is QIH.
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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.