| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 03760290230026 | 3.0 | SDX0340V3.0 | SDX Trolley | IYE,LHN | Accelerator, Linear, Medical,System, Radiation Therapy, Charged-Particle, Medical | 2 | SDX System |
| 2 | 03760290230125 | V1.0 | SDX0365V1.0 | Gating Module for Probeam | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 3 | 03760290230019 | 3.0 | SDX0350V3.0 | SDX Module | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 4 | 03615070000200 | 1.0 | 0340 | SDX Trolley | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 5 | 03615070000101 | 2.1 | 0350 | SDX Module | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 6 | 03615070000804 | V1.0 | SDX0360V1.0 | Gating Module for IBA Proteus Plus | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 7 | 03760290230156 | V1.0 | SDX0367V1.0 | Gating Module RT Mevion S250i | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 8 | 03760290230149 | V1.0 | SDX0366V1.0 | Gating Module for Varian TrueBream | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 9 | 03760290230118 | V1.0 | SDX0360V1.0 | Gating Module for IBA ProteusPlus | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 10 | 03760290230101 | V2.0 | SDX0359V2.0 | Gating Module for Varian C-Series | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 11 | 03615070000705 | V2.0 | SDX0359V2.0 | Gating Module for Varian C-series | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 12 | 03615070000606 | 3.0 | SDX0340V3.0 | SDX Trolley | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 13 | 03615070000507 | 3.0 | SDX0350V3.0 | SDX Module | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 14 | 03615070000408 | 1.0 | SDX0361V1.0 | Gating Module for Siemens 4D-CT | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| 15 | 03615070000903 | 1.0 | SDX0365V1.0 | Gating Module for Probeam | LHN,IYE | System, Radiation Therapy, Charged-Particle, Medical,Accelerator, Linear, Medical | 2 | SDX System |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B673MYOSTRAIN05040 | 5.4 | MyoStrain software is an image processing device that post-processes strain-enco 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. | MyoStrain | MYOCARDIAL SOLUTIONS, INC. | |
| 2 | B673MYOSTRAIN0502030 | 5.2.3 | MyoStrain software is an image processing device that post-processes strain-enco 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. | MyoStrain | MYOCARDIAL SOLUTIONS, INC. | |
| 3 | B673MYOSTRAIN0502020 | 5.2.2 | MyoStrain software is an image processing device that post-processes strain-enco 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 | Myostrain | MYOCARDIAL SOLUTIONS, INC. | |
| 4 | B50510130 | 1013 (vers 1.3) | IQM is quality assurance device for medical linear accelerators for verifying th IQM is quality assurance device for medical linear accelerators for verifying the treatment beam. | IQM Integral Quality Monitor | IRT SYSTEMS GMBH | |
| 5 | B501THINKQA010004 | 1.0.4 | 1.0.4 | Radiation therapy quality assurance and error detection software suite | ThinkQA, EPIbeam | DOSISOFT |
| 6 | B501THINKQA010002 | 1.0.2 | 1.0.2 | Radiation therapy quality assurance and error detection software suite | ThinkQA, EPIbeam | DOSISOFT |
| 7 | B501MU2NET020101 | 2.1.1 | 2.1.1 | MU2net is a standalone software device designed to perform secondary monitor uni MU2net is a standalone software device designed to perform secondary monitor unit (MU) or dose calculation based on DICOM RT Plan data sets provided by Radiotherapy Treatment Planning Systems. | MU2net | DOSISOFT |
| 8 | B365805000 | 80-500 | Navigator CS | AKTINA CORP. | ||
| 9 | B365702100 | 70-210 | Prone Breast Immobilization System | AKTINA CORP. | ||
| 10 | B365702000 | 70-200 | SenoView Prone Breast System | AKTINA CORP. | ||
| 11 | B365701000 | 70-100 | SenoView Prone Breast Board | AKTINA CORP. | ||
| 12 | B365608120 | 60-812 | ArmCradle4 | AKTINA CORP. | ||
| 13 | B365605800 | 60-580 | ArmCradle3 | AKTINA CORP. | ||
| 14 | B365605600 | 60-560 | Arm Cradle | AKTINA CORP. | ||
| 15 | B365605500 | 60-550 | Foot Stabilizer | AKTINA CORP. | ||
| 16 | B365605450 | 60-545 | Indexing Bar | AKTINA CORP. | ||
| 17 | B365605430 | 60-543 | Adjustable Knee Support | AKTINA CORP. | ||
| 18 | B365605400 | 60-540 | Knee Support | AKTINA CORP. | ||
| 19 | B365605250 | 60-525 | Paddle | AKTINA CORP. | ||
| 20 | B365605220 | 60-522 | SBRT Universal Crossbar | AKTINA CORP. | ||
| 21 | B365605200 | 60-520 | Crossbar Assembly | AKTINA CORP. | ||
| 22 | B365605100 | 60-510 | Head Support System | AKTINA CORP. | ||
| 23 | B365605000 | 60-500 | Memorial Body Cradle | AKTINA CORP. | ||
| 24 | B365603120 | 60-312 | Respiratory Belt with Bladder, Large | AKTINA CORP. | ||
| 25 | B365603110 | 60-311 | Respiratory Belt with Bladder, Medium | AKTINA CORP. | ||
| 26 | B365603100 | 60-310 | Respiratory Belt with Bladder, Small | AKTINA CORP. | ||
| 27 | B365602800 | 60-280 | Localization Bridge | AKTINA CORP. | ||
| 28 | B365602300 | 60-230 | Wrist and Forearm Support | AKTINA CORP. | ||
| 29 | B365602200 | 60-220 | Hip-Knee-Foot Immobilizer | AKTINA CORP. | ||
| 30 | B365601900 | 60-190 | Belly Compression Arch Kit | AKTINA CORP. | ||
| 31 | B365601700 | 60-170 | PinPoint C-Spine Kit | AKTINA CORP. | ||
| 32 | B365601600 | 60-160 | Overhead Arm Support | AKTINA CORP. | ||
| 33 | B365601500 | 60-150 | Shoulder Restraint | AKTINA CORP. | ||
| 34 | B365601400 | 60-140 | Hand Grip | AKTINA CORP. | ||
| 35 | B365601200 | 60-120 | Crossbar Assembly | AKTINA CORP. | ||
| 36 | B365601100 | 60-110 | Frame Assembly | AKTINA CORP. | ||
| 37 | B365601000 | 60-100 | Memorial Body Cradle, Base System | AKTINA CORP. | ||
| 38 | B365579050 | 57-905 | Smart Tray, Siemens, Star Hole Pattern, Lexan, Cross-Hairs | AKTINA CORP. | ||
| 39 | B365579010 | 57-901 | Smart Tray, Siemens, Solid, Lexan, Cross-Hairs | AKTINA CORP. | ||
| 40 | B36556300MX600 | 56-300-MX60 | Wedge Filter, Cross- Plane, MLC, 60 Degrees, Siemens | AKTINA CORP. | ||
| 41 | B36556300MX450 | 56-300-MX45 | Wedge Filter, Cross- Plane, MLC, 45 Degrees, Siemens | AKTINA CORP. | ||
| 42 | B36556300MX300 | 56-300-MX30 | Wedge Filter, Cross- Plane, MLC, 30 Degrees, Siemens | AKTINA CORP. | ||
| 43 | B36556300MX150 | 56-300-MX15 | Wedge Filter, Cross- Plane, MLC, 15 Degrees, Siemens | AKTINA CORP. | ||
| 44 | B36556300MI600 | 56-300-MI60 | Wedge Filter, In- Plane, MLC, 60 Degrees, Siemens. | AKTINA CORP. | ||
| 45 | B36556300MI450 | 56-300-MI45 | Wedge Filter, In- Plane, MLC, 45 Degrees, Siemens | AKTINA CORP. | ||
| 46 | B36556300MI300 | 56-300-MI30 | Wedge Filter, In- Plane, MLC, 30 Degrees, Siemens | AKTINA CORP. | ||
| 47 | B36556300MI150 | 56-300-MI15 | Wedge Filter, In- Plane, MLC, 15 Degrees, Siemens. | AKTINA CORP. | ||
| 48 | B36556300DX600 | 56-300-DX60 | Wedge Filter, Cross- Plane, Digital, 60 Degrees, Siemens | AKTINA CORP. | ||
| 49 | B36556300DX450 | 56-300-DX45 | Wedge Filter, Cross- Plane, Digital, 45 Degrees, Siemens | AKTINA CORP. | ||
| 50 | B36556300DX300 | 56-300-DX30 | Wedge Filter, Cross- Plane, Digital, 30 Degrees, Siemens | AKTINA CORP. |