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FDA 510(k)

TeraRecon Cardiac.Chambers.MR (1.0.0)

K-Number: K241312 · 2024-11-05

ApplicantTerarecon,Inc.
Decision Date2024-11-05
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TeraRecon Cardiac.Chambers.MR (1.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Terarecon,Inc.. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K241312. 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 Cardiac.Chambers.MR (1.0.0)?

TeraRecon Cardiac.Chambers.MR (1.0.0) is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Terarecon,Inc.. The 510(k) number is K241312.

When did TeraRecon Cardiac.Chambers.MR (1.0.0) receive FDA 510(k) clearance?

TeraRecon Cardiac.Chambers.MR (1.0.0) received FDA 510(k) clearance on 2024-11-05, under 510(k) number K241312.

Who is the listed applicant for TeraRecon Cardiac.Chambers.MR (1.0.0)?

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 Cardiac.Chambers.MR (1.0.0)?

The FDA product code for TeraRecon Cardiac.Chambers.MR (1.0.0) 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.

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