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Heartvista, Inc.

US

Last updated May 30, 2026

What Heartvista, Inc. makes

Heartvista, Inc. makes MRI system application software, MRI system operation software, and MRI system operator consoles. Specific products include the HeartVista Cardiac Package and the RTHawk system, which is offered in configurations such as the RTHawk with HeartVista Cardiac Package and the RTHawk with HeartVista Workstation.

The devices are classified as Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Heartvista, Inc. make?

Heartvista, Inc. makes MRI system application software, MRI system operation software, and MRI system operator consoles, including products such as the HeartVista Cardiac Package and the RTHawk system in various configurations like the RTHawk with HeartVista Cardiac Package or the RTHawk with HeartVista Workstation.

Where is Heartvista, Inc. based?

Heartvista, Inc. is based in the United States, as stated in the company's location information within the provided device data.

Which registries list Heartvista, Inc.'s devices?

Heartvista, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries, which are the only registries specified for the company's devices in the provided data.

How are Heartvista, Inc.'s devices classified?

Heartvista, Inc.'s devices are classified as Class II medical devices, according to the device classification information provided in the data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
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Phone
650-800-7937
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
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DUNS Number
602748373

Catalogue (8)

DeviceModel / ReferenceRegistriesClassStatus
HeartVista Cardiac Package 030004
FDA UDI
Class IIUnknown
HeartVista Cardiac Package 020301
FDA UDI
Class IIActive
RTHawk, HeartVista Cardiac Package K212233
FDA 510(k)
Class IIActive
RTHawk, HeartVista Cardiac Package K183274
FDA 510(k)
Class IIActive
RTHawk, HeartVista Workstation with RTHawk K142997
FDA 510(k)
Class IIActive
RTHawk, HeartVista Cardiac Package K170090
FDA 510(k)
Class IIActive
Rthawk, Rthawk, Or Heartvista Workstation With Rthawk K133848
FDA 510(k)
Class IIActive
RTHawk, HeartVista Cardiac Package K153740
FDA 510(k)
Class IIActive

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