suiteHEART

GUDID 00850001088015

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.

NEOSOFT LLC

MRI system application software

• Primary Device ID: 00850001088015
• NIH Device Record Key: ebeb905d-598a-4b2d-a483-07d01347bc6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: suiteHEART
• Version Model Number: 5
• Company DUNS: 079151785
• Company Name: NEOSOFT LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001088015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130228

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-23
• Device Publish Date: 2019-07-15

On-Brand Devices [suiteHEART]

• 00864747000279: suiteHEART® Software is intended to assist trained clinical personnel in the qualification and
• 00864747000262: suiteHEART® Software is intended to assist trained clinical personnel in the qualification and
• 00864747000255: suiteHEART® Software is intended to assist trained clinical personnel in the qualification and
• 00864747000248: suiteHEART® Software is intended to assist trained clinical personnel in the qualification and
• 00864747000224: suiteHEART® Software is intended to assist trained clinical personnel in the qualification and
• 00864747000217: suiteHEART® Software is intended to assist trained clinical personnel in the qualification and
• 00864747000200: suiteHEART® Software is intended to assist trained clinical personnel in the qualification and
• 00850001088008: suiteHEART Software is intended to assist trained clinical personnel in the qualification and qu
• 00850001088015: suiteHEART Software is intended to assist trained clinical personnel in the qualification and qu