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 software 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
- 5 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 software 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
- 00850001088015 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
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HCT/P
No
FDA UDI
Premarket Exempt
No
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Lot / Batch Number
No
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Serial Number
No
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Expiration Date
No
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Manufacturing Date
No
FDA UDI
Category: MRI system application software
suiteHEART by Neosoft, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI system application software.
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- cvi42 — Circle Cardiovascular Imaging · Class II
- MR-RT — Philips Oy · Class II
- RTgo — Philips Oy · Class II
- syngo.MR Spectroscopy — Siemens Healthcare · Class II
- Quantib ND — Quantib B.V. · Class II
- FerriScan, Cardiac T2* — Resonance Health Analysis Services Pty, Ltd. · Class II
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 ebeb905d-598a-4b2d-a483-07d01347bc6d 34 fields · synced May 30, 2026