RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK— 510(k) K133848

Name: FDA 510(k) clearance K133848
Creator: U.S. Food and Drug Administration
Published: 2014-06-25

Substantially Equivalent

Heartvista, Inc.

FDA 510(k) clearance K133848 for RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK, Substantially Equivalent on 2014-06-25. Applicant: Heartvista, Inc.. Device class: 2.

Clearance details

Applicant: Heartvista, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2013-12-18
Decision date: 2014-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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K170090 — RTHawk, HeartVista Cardiac Package2017-07-14
K153740 — RTHawk, HeartVista Cardiac Package2016-06-30
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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.