TeraRecon Cardiovascular.Calcification.CT
K-Number: K250288 · 2025-10-23
ApplicantTerarecon,Inc.
Decision Date2025-10-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TeraRecon Cardiovascular.Calcification.CT is a medical device manufactured by Terarecon,Inc.. It received FDA 510(k) clearance on 2025-10-23 under approval number K250288. 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 Cardiovascular.Calcification.CT?
TeraRecon Cardiovascular.Calcification.CT is a medical device that received FDA 510(k) clearance on 2025-10-23. It is manufactured by Terarecon,Inc.. The 510(k) number is K250288.
When was TeraRecon Cardiovascular.Calcification.CT approved by the FDA?
TeraRecon Cardiovascular.Calcification.CT received FDA 510(k) clearance on 2025-10-23, under approval number K250288.
What company makes TeraRecon Cardiovascular.Calcification.CT?
TeraRecon Cardiovascular.Calcification.CT is manufactured by Terarecon,Inc..
What is the FDA product code for TeraRecon Cardiovascular.Calcification.CT?
The FDA product code for TeraRecon Cardiovascular.Calcification.CT 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.