MyoStrain
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…
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.
Who Else Makes It
Concentrated in Shanghai (3), Beijing (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Chenguang Medical Technologies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
| GE Healthcare (China) Co., Ltd. – Tianjin | Tianjin | Tianjin | Specification developer | 3 |
| Shenzhen RF Tech Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 2 |
| Shanghai Chenshi Medical Instruments Co., Ltd. | Shanghai | Shanghai | Exporter | 2 |
| MRI Division, Beijing Wandong Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
| Jiangsu Magspin Instrument Co., Ltd. | Kunshan | Jiangsu | Manufacturer | 1 |
| Xingaoyi Medical Equipment Co., Ltd. | Yuyao | Zhejiang | Manufacturer | 1 |
| Sino Canada Health Engineering Research Institute (Hefei) Ltd. (Scheri) | Hefei | Anhui | Complaint-file establishment | 1 |
Record
| Listed by | Myocardial Solutions, United States |
|---|---|
| FDA product code | LNH |
| Device type | System, Nuclear Magnetic Resonance Imaging |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Manufacturer |
| 510(k) | K182756 |
| Record published | 2024-11-12 |
| Record revised | 2023-12-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date |
| Distribution end date | 2035-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6.0.1 | In distribution | |
| 6.1 | In distribution | |
| 5.1.2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ingenia | Philips Medical Systems Nederland B.V. | 72 |
| System, Nuclear Magnetic Resonance Imaging | GE Medical Systems, L.L.C. | 40 |
| System, Nuclear Magnetic Resonance Imaging | Medtronic Navigation, Inc. | 23 |
| Uni-frame® Thermoplastic | Medtec LLC | 19 |
| Positioning Cushion | Medtec LLC | 18 |
| Posicast® Thermoplastic | Medtec LLC | 18 |
| System, Nuclear Magnetic Resonance Imaging | GE Healthcare (Tianjin) Company Limited | 16 |
| Invivo | Philips DS North America LLC | 15 |
| Type-S™ Thermoplastic | Medtec LLC | 14 |
| Aperto Lucent | Fujifilm Corporation | 13 |
| MRI Integral “T” with Check Valve for Medrad® Spectris MR Injector | Bayer Medical Care Inc. | 11 |
| PPG Finger Band | IVY Biomedical Systems, Inc. | 11 |
Showing 12 of 478. All products under System, Nuclear Magnetic Resonance Imaging
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241607 | 2024-08-26 |
| K182756 | 2019-02-14 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P860010 | 1988-06-12 | INSTRUMENTARIUM ULF MR IMAGING SYSTEM | Palomex Instrumentarium Corp. |
| P860062 | 1988-05-25 | RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST | Resonex, Inc. |
| P850043 | 1987-12-30 | MAGNISCAN 5000 MRI SYSTEM | Thomson-Cgr Medical Corp. |
| P830074 | 1987-11-25 | GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS | General Electric Co. |
| P840063 | 1987-08-11 | GYROSCAN(TM) | Philips Medical Systems Technologies Ltd |
| P840007 | 1987-04-02 | GYREX, MODELS S3500 & S5000 | Elscint, Inc. |
| P830076 | 1986-10-08 | FONAR NMR WHOLE BODY SCANNER BETA 3000 | Fonar Corp. |
| P830052 | 1986-05-28 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. |
| P830051 | 1986-04-30 | TESLACON(TM) NMR IMAGING SYSTEM | Technicare Corp. |
| P830053 | 1985-12-18 | DIASONICS NMR IMAGING SYSTEM | Diasonics, Inc. |
| P830081 | 1985-06-06 | MAGNETOM | Siemens Healthcare Limited |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.