MyoStrain
GUDID B672MYOSTRAIN050102
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 | B672MYOSTRAIN050102 |
| NIH Device Record Key | 940b2c4a-f7f3-4074-9f1c-e10e2b7b450a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyoStrain |
| Version Model Number | 5.1.2 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com | |
| Phone | 9196387633 |
| Linda.Horne@myocardialsolutions.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B672MYOSTRAIN050102 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182756
FDA Product Code
| LNH | System, Nuclear Magnetic Resonance Imaging |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2019-03-05 |
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 |
Trademark Results [MyoStrain]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MYOSTRAIN 87313309 5551593 Live/Registered |
Myocardial Solutions, Inc. 2017-01-25 |
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