RTHawk, HeartVista Cardiac Package
FDA 510(k) K183274 · Heartvista, Inc.
510(k) numberK183274
Submission
- Device name
- RTHawk, HeartVista Cardiac Package
- Applicant
- Heartvista, Inc.
Los Altos, CA, US - Received
- November 23, 2018
- Decision date
- October 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Decision |
|---|---|---|
| K212233 | RTHawk, HeartVista Cardiac PackageLNH · Traditional | 10/05/2021SE |
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| K153740 | RTHawk, HeartVista Cardiac PackageLNH · Traditional | 06/30/2016SE |
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Questions and answers
When was RTHawk, HeartVista Cardiac Package cleared by the FDA?
RTHawk, HeartVista Cardiac Package (K183274) received a 510(k) decision of Substantially Equivalent on October 18, 2019, 329 days after the submission was received.
What is the product code of K183274?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.