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FDA 510(k)

RTHawk, HeartVista Cardiac Package

K-Number: K183274 · 2019-10-18

ApplicantHeartvista, Inc.
Decision Date2019-10-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RTHawk, HeartVista Cardiac Package is the device name listed in this FDA 510(k) record. The listed applicant is Heartvista, Inc.. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K183274. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RTHawk, HeartVista Cardiac Package?

RTHawk, HeartVista Cardiac Package is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Heartvista, Inc.. The 510(k) number is K183274.

When did RTHawk, HeartVista Cardiac Package receive FDA 510(k) clearance?

RTHawk, HeartVista Cardiac Package received FDA 510(k) clearance on 2019-10-18, under 510(k) number K183274.

Who is the listed applicant for RTHawk, HeartVista Cardiac Package?

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

What is the FDA product code for RTHawk, HeartVista Cardiac Package?

The FDA product code for RTHawk, HeartVista Cardiac Package is LNH.

Other records listing Heartvista, 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.

K212233RTHawk, HeartVista Cardiac PackageK170090RTHawk, HeartVista Cardiac PackageK153740RTHawk, HeartVista Cardiac Package

Related Devices (Code: LNH)

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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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