FDA.reportPublic FDA data

Myocardial Solutions

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30060158473006015847Myocardial Solutions1N2026-01-014819 Emperor Blvd Ste 140 Durham NC US 27703

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B672MYOSTRAIN050102MyoStrain - 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 measurements9196387633Linda.Horne@myocardialsolutions.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2190501821536857K241607MyoStrain (6.0)LNH2024-08-26
2190501339166956K182756MyoStrain 5.1LNH2019-02-14
2190501224227330K111833VIRTUELLZ2011-09-21
2190501571882557K100352DIAGNOSOFT HARP MODEL 2.06LNH2010-03-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LNH32024-08-26
LLZ12011-09-21

PMN#

GUDID#