Identity
- Trade Name
- Myostrain FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 5.2.2 FDA UDI
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B673MYOSTRAIN0502020 FDA UDI
- FDA Product Code
- LHN FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
Myostrain by Myocardial Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiology DICOM image processing application software.
- Imbio Freya — Imbio, LLC · Class II
- Pacs View — BRIT SYSTEMS · Class II
- XR90 System, LOGIQ, Upgrade Kit — MediView XR · Class II
- OptiVu™ Mixed Reality — Orthosoft Inc · Class II
- PowerLook PRO+ Rack-Mount, OUS — Icad, Inc. · Class I
- Annalise Triage — Annalise-Ai Pty , Ltd. · Class II
- PowerLook PRO+ 4GPU Tower Platform, US — Icad, Inc. · Class I
- PowerLook PRO+ 4GPU Tower Platform, OUS — Icad, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Myocardial Solutions, Inc.
Sources (1)
- FDA UDI f5764f20-61aa-4ada-86e8-191007f29ead 34 fields · synced May 30, 2026