MyoStrain

GUDID B673MYOSTRAIN0502030

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, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart. A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by a physician and can be communicated to referring physicians to support the determination of a diagnosis.

MYOCARDIAL SOLUTIONS, INC.

Radiology DICOM image processing application software

• Primary Device ID: B673MYOSTRAIN0502030
• NIH Device Record Key: c7e0ba1c-7efa-4ece-9fc6-bfc2f6482149
• Commercial Distribution Discontinuation: 2031-04-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoStrain
• Version Model Number: 5.2.3
• Company DUNS: 080294654
• Company Name: MYOCARDIAL SOLUTIONS, INC.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B673MYOSTRAIN0502030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182756

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: 2021-04-26
• Device Publish Date: 2021-04-16

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
• B672MYOSTRAIN0600010: MyoStrain software is an image processing device that post-processes strain-encoded (SENC) image