suiteHEART

FDA UDI

Class II (US FDA UDI)

by Neosoft, LLC

Identity

Trade Name: suiteHEART FDA UDI
Generic Name: MRI system application software FDA UDI
Device Name: suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. FDA UDI
Model / Reference: 4.0.1 FDA UDI
Description: suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. FDA UDI

Identifiers

Primary DI / UDI-DI: 00864747000224 FDA UDI
510(k) Number: K130228 FDA UDI
FDA Product Code: LLZ FDA UDI
GMDN Term: MRI system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

FDA UDI

suiteHEART by Neosoft, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K130228 also covers:

suiteHEART — Neosoft, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Neosoft, LLC

Sources (1)

FDA UDI f042d997-438d-4bad-88d5-d3dab84cda78 35 fields · synced Jun 8, 2026