FDA.reportPublic FDA data

MyoStrain

Primary DI
B672MYOSTRAIN050102
Brand
MyoStrain
Company
MYOCARDIAL SOLUTIONS, INC.
Model
5.1.2
Device description
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
Published
2019-03-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182756000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182756000MyoStrain 5.1Myocardial Solutions2019-02-14LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B672MYOSTRAIN050102PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9196387633Linda.Horne@myocardialsolutions.com

Regulatory Flags#

DUNS number
080294654
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B673MYOSTRAIN05040MyoStrain5.42021-09-22
B673MYOSTRAIN0502030MyoStrain5.2.32021-04-16
B673MYOSTRAIN0502020Myostrain5.2.22020-10-10
B672MYOSTRAIN060100MyoStrain6.12025-11-11
B672MYOSTRAIN0600010MyoStrain6.0.12024-11-12

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Primary DI, Brand, Company table
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