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FDA 510(k)

Cardiac Guidance

K-Number: K243065 · 2025-01-15

ApplicantCaption Health, Inc.
Decision Date2025-01-15
Product CodeQJU
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cardiac Guidance is the device name listed in this FDA 510(k) record. The listed applicant is Caption Health, Inc.. It received FDA 510(k) clearance on 2025-01-15 under 510(k) number K243065. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardiac Guidance?

Cardiac Guidance is a medical device that received FDA 510(k) clearance on 2025-01-15. The listed applicant is Caption Health, Inc.. The 510(k) number is K243065.

When did Cardiac Guidance receive FDA 510(k) clearance?

Cardiac Guidance received FDA 510(k) clearance on 2025-01-15, under 510(k) number K243065.

Who is the listed applicant for Cardiac Guidance?

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

What is the FDA product code for Cardiac Guidance?

The FDA product code for Cardiac Guidance is QJU.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06717373Point-of-Care Echocardiography in Patients With Known or Suspected Aortic StenosisCOMPLETED

Other records listing Caption Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210747Caption Interpretation Automated Ejection Fraction SoftwareK201992Caption GuidanceK200621Caption Interpretation Automated Ejection Fraction SoftwareK200755Caption Guidance

Related Devices (Code: QJU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260338ThinkSono GuidanceThinkSono GmbHK260780HeartFocusDeskiK251416UltraSight GuidanceUltrasight , Ltd.K242807HeartFocus (V.1.1.1)DeskiK223347UltraSight AI GuidanceUltrasight, Inc.K201992Caption GuidanceCaption Health

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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