Myostrain

GUDID B673MYOSTRAIN0502020

MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements

MYOCARDIAL SOLUTIONS, INC.

Radiology DICOM image processing application software

• Primary Device ID: B673MYOSTRAIN0502020
• NIH Device Record Key: f5764f20-61aa-4ada-86e8-191007f29ead
• Commercial Distribution Discontinuation: 2030-10-10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myostrain
• Version Model Number: 5.2.2
• Company DUNS: 080294654
• Company Name: MYOCARDIAL SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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
HIBCC	B673MYOSTRAIN0502020 [Primary]

FDA Product Code

• LHN: System, Radiation Therapy, Charged-Particle, Medical

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: 2020-10-19
• Device Publish Date: 2020-10-10

On-Brand Devices [Myostrain]

• B672MYOSTRAIN050102: MyoStrain software is an image processing device that post-processes strain-encoded (SENC) image
• B673MYOSTRAIN0502020: MyoStrain software is an image processing device that post-processes strain-encoded (SENC) image
• B673MYOSTRAIN0502030: MyoStrain software is an image processing device that post-processes strain-encoded (SENC) image
• B673MYOSTRAIN05040: MyoStrain software is an image processing device that post-processes strain-encoded (SENC) image