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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Terarecon,Inc.. It received FDA 510(k) clearance on 2025-10-23 under 510(k) 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. The listed applicant is Terarecon,Inc.. The 510(k) number is K250288.

When did TeraRecon Cardiovascular.Calcification.CT receive FDA 510(k) clearance?

TeraRecon Cardiovascular.Calcification.CT received FDA 510(k) clearance on 2025-10-23, under 510(k) number K250288.

Who is the listed applicant for TeraRecon Cardiovascular.Calcification.CT?

The FDA 510(k) record lists Terarecon,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TeraRecon Cardiovascular.Calcification.CT?

The FDA product code for TeraRecon Cardiovascular.Calcification.CT is QIH.

Other records listing Terarecon,Inc. as applicant

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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.

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