| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 07090045490365 | P001000-04 | P001000-04 | Biim Ultrasound L12-4 Linear Array Transducer (Version P2.0) | IYO,ITX,LLZ | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Image Processing, Radiological | Biim Ultrasound L12-4 Linear Array Transducer (Version P2.0) | |
| 2 | 07090045490143 | P001157 | P001157 | Biim iOS App, P1.2 | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Biim iOS App, P1.2 |
| 3 | 07090045490310 | P001418 | P001418 | Biim Android App, P1.3.2 | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Biim Android App, P1.3.2 |
| 4 | 07090045490198 | P001228 | P001228 | Biim Android App, P1.3 | IYO,ITX,LLZ | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Image Processing, Radiological | 2 | Biim Android App, P1.3 |
| 5 | 07090045490099 | P001052 | P001052 | Battery Charger, Biim Ultrasound | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | Battery Charger, Biim Ultrasound | |
| 6 | 07090045490358 | P001253 | P001253 | Battery Charger AU, Biim Ultrasound | IYO,ITX,LLZ | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Image Processing, Radiological | Battery Charger AU, Biim Ultrasound | |
| 7 | 07090045490303 | P001417 | P001417 | Biim iOS App, P1.3.2 | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Biim iOS App, P1.3.2 |
| 8 | 07090045490068 | P001175 | P001175 | Probe Holder, (V1) Biim Ultrasound | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | Probe Holder, (V1) Biim Ultrasound | |
| 9 | 07090045490327 | P001424 | P001424 | Biim iOS App, P2.0 | IYO,ITX,LLZ | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Image Processing, Radiological | 2 | Biim iOS App, P2.0 |
| 10 | 07090045490266 | P001198 | P001198 | Battery Charger EU, Biim Ultrasound | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | Battery Charger EU, Biim Ultrasound | |
| 11 | 07090045490228 | P001402 | P001402 | Biim iOS App, P1.3.1 | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Biim iOS App, P1.3.1 |
| 12 | 07090045490273 | P001197 | P001197 | Battery Charger UK, Biim Ultrasound | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Battery Charger UK, Biim Ultrasound |
| 13 | 07090045490235 | P001403 | P001403 | Biim Android App, P1.3.1 | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Biim Android App, P1.3.1 |
| 14 | 07090045490181 | P001227 | P001227 | Biim iOS App, P1.3 | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Biim iOS App, P1.3 |
| 15 | 07090045490129 | P001160 | P001160 | Adapter Bracket, Biim Ultrasound | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Adapter Bracket, Biim Ultrasound |
| 16 | 07090045490051 | P001137 | P001137 | Probe holder, (V2) Biim Ultrasound | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | Probe holder, (V2) Biim Ultrasound | |
| 17 | 07090045490013 | P001117 | P001117 | Biim iOS App, P1.1 | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Biim iOS App, P1.1 |
| 18 | 07090045490006 | P001000 | P001000 | Biim Ultrasound L12-4 Linear Array Transducer | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | Biim Ultrasound L12-4 Linear Array Transducer | |
| 19 | 07090045490037 | P001050 | P001050 | Battery, Biim Ultrasound | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | Battery, Biim Ultrasound | |
| 20 | 07090045490334 | P001425 | P001425 | Biim Android App, P2.0 | IYO,ITX,LLZ | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Syst System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,System, Image Processing, Radiological | 2 | Biim Android App, P2.0 |
| 21 | 07090045490150 | P001158 | P001158 | Biim Android App, P1.2 | LLZ,ITX,IYO | System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System System, Image Processing, Radiological,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Biim Android App, P1.2 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B995LI10050 | LI-1005 | Velacur is a portable ultrasonic elastography machine used to assess and monitor Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided. | Velacur | SONIC INCYTES MEDICAL CORP. | |
| 2 | B995LI10050 | LI-1005 | Velacur is a portable ultrasonic elastography machine used to assess and monitor Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided. | Velacur | SONIC INCYTES MEDICAL CORP. | |
| 3 | B940IVZBKIT0 | ImmersiveTouch4 | ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options. | ImmersiveTouch | IMMERSIVETOUCH, INC. | |
| 4 | B940IMMERSIVEVIEW0 | V3.0 | The ImmersiveTouch simulators are intended as pre-operative software for simulat The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options. | ImmersiveTouch | IMMERSIVETOUCH, INC. | |
| 5 | B843UNISYN6110 | 6-1-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 6 | B843UNISYN5610 | 5-6-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 7 | B843UNISYN5520 | 5-5-2-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 8 | B843UNISYN5510 | 5-5-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 9 | B843UNISYN5410 | 5-4-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 10 | B843UNISYN531P20 | 5-3-1-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 11 | B843UNISYN431P10 | 4-3-1-P1 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 12 | B843UNISYN425P20 | 4-2-5-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 13 | B80731 | Breast MRI SE | 3 | QuantX is a software program that is used to view and analyze patient breast images. | QuantX | QLARITY IMAGING, LLC |
| 14 | B80721 | Breast MRI Biopsy Guidance Plugin | 2 | The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assi The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures. | QuantX | QLARITY IMAGING, LLC |
| 15 | B801THINQ1130 | 1.1.3 | THINQ | CORTICOMETRICS LLC | ||
| 16 | B801THINQ1000 | 1.0.0 | THINQ | CORTICOMETRICS LLC | ||
| 17 | B7671R522 | 5.2.2 | Rapid | Rapid System Update | Rapid | ISCHEMAVIEW, INC. |
| 18 | B7671R521 | 5.2.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 19 | B7671R520 | 5.2.0 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 20 | B7671R512 | 5.1.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 21 | B7671R511 | 5.1.1 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 22 | B7671R5030 | 5.0.3 | Rapid | ISCHEMAVIEW, INC. | ||
| 23 | B761RAPID510 | 5.1 | Rapid 5.1 | Rapid | ISCHEMAVIEW, INC. | |
| 24 | B761RAPID50210 | 5.0.2.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 25 | B761RAPID5020 | 5.0.2 | RAPID | ISCHEMAVIEW, INC. | ||
| 26 | B761RAPID5010 | 5.0.1 | RAPID | ISCHEMAVIEW, INC. | ||
| 27 | B761RAPID500 | 5.0 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 28 | B761RAPID49101 | 4.9.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 29 | B761RAPID48302 | 4.8.3 | RAPID | RAPID is a Platform for brain image analysis. | RAPID | ISCHEMAVIEW, INC. |
| 30 | B748AR350050DUS0 | AR-3500-50D-US | Sterile ultrasound probe cover and ultrasound gel. | Synergy MSK Ultrasound Strl Cover & Parker Gel | SAFERSONIC MEDIZINPRODUKTE HANDELS GMBH | |
| 31 | B748AR350050DEU0 | AR-3500-50D-US | Sterile ultrasound probe cover and ultrasound gel. | Synergy MSK Ultrasound Strl Cover & Parker Gel | SAFERSONIC MEDIZINPRODUKTE HANDELS GMBH | |
| 32 | B745VASCUCAPA2 | A.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
| 33 | B745ELUCIDVIVOA3 | A.3 | ElucidVivo | ELUCID BIOIMAGING INC. | ||
| 34 | B745A40 | A.1.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
| 35 | B725INITVV12 | 1.2 | INITVV | Visualize:Vascular is software that renders 3D images of vascular segments from Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging. | Visualize:Vascular | SALIENT IMAGING |
| 36 | B688IMAGEQUBE0 | ImageQube | ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication Sy ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication System (PACS), is a medical imaging information system that securely transmits, receives, and archives digitally transmitted images and provides radiologists access to patient information, medical images, annotated print pages, transcribed reports. | ImageQube | INTUITIVE IMAGING INFORMATICS, LLC | |
| 37 | B664CVM20 | CVM2 | Arterys Cardio DL | ARTERYS INC. | ||
| 38 | B664AVM30 | AVM3 | Arterys Viewer | ARTERYS INC. | ||
| 39 | B664AOM40 | AOM4 | Arterys Oncology DL | ARTERYS INC. | ||
| 40 | B664AMM60 | AMM6 | Arterys MICA | ARTERYS INC. | ||
| 41 | B664AMM50 | AMM5 | Arterys MICA | ARTERYS INC. | ||
| 42 | B621ICOBRAINCTP10 | 1 | icobrain ctp | ICOMETRIX NV | ||
| 43 | B621ICOBRAIN60 | 6 | icobrain | ICOMETRIX NV | ||
| 44 | B621ICOBRAIN50 | 5 | icobrain | ICOMETRIX NV | ||
| 45 | B621ICOBRAIN40 | 4.0 | icobrain | ICOMETRIX NV | ||
| 46 | B621ICOBRAIN30 | 3 | icobrain is software intended for automatic labeling, visualization and volumetr icobrain is software intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. | icobrain | ICOMETRIX NV | |
| 47 | B621ICOBRAIN20 | 2 | icobrain is software intended for automatic labeling, visualization and volumetr icobrain is software intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. | icobrain | ICOMETRIX NV | |
| 48 | B616UVXS0 | XS | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
| 49 | B616UVXR0 | XR | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
| 50 | B616UVXP0 | XP | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION |