| 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 | 07090045490020 | P001118 | P001118 | Biim Android 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 Android App, P1.1 |
| 10 | 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 |
| 11 | 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 | |
| 12 | 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 |
| 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 | 00190376470351 | AIX21000 | Vea - Mobile Alignment App | VEA | ALPHATEC SPINE, INC. | |
| 2 | 00184360000709 | 806302012 | s5i Control Console | VOLCANO CORPORATION | ||
| 3 | 00184360000686 | 807401001 | s5i Imaging System Workstation | VOLCANO CORPORATION | ||
| 4 | 00184360000525 | 807301001 | s5 PC Module | VOLCANO CORPORATION | ||
| 5 | 00184360000327 | R100 | 804547001 | R-100 Pullback Device | VOLCANO CORPORATION | |
| 6 | 00092237617281 | LS5288L1 | Conductive Ultrasound Gel - | LG | COMPASS HEALTH BRANDS CORP. | |
| 7 | 00092237617274 | LS5266L1 | Conductive Ultrasound Gel - | LG | COMPASS HEALTH BRANDS CORP. | |
| 8 | 00092237613269 | LS5266 | TheraSonic Conductive Gel, 16- | N/A | COMPASS HEALTH BRANDS CORP. | |
| 9 | 00092237613252 | LS5288 | TheraSonic Conductive Gel, 8-o | N/A | COMPASS HEALTH BRANDS CORP. | |
| 10 | 00092237613245 | LC2828 | TheraSonic Conductive Gel, 2-o | N/A | COMPASS HEALTH BRANDS CORP. | |
| 11 | 00092237611531 | LS5255 | TheraSonic Conductive Gel, 5L | N/A | COMPASS HEALTH BRANDS CORP. | |
| 12 | 00083059012071 | 1207 | The Aware™ Pad is intended to be used as an aid for performing breast self-examination. | Aware Breast Self-Exam Pad | BIOMERICA, INC. | |
| 13 | 00083059012033 | 1203 | The Aware™ Pad is intended to be used as an aid for performing breast self-examination. | Aware Breast Self-Exam Pad | BIOMERICA, INC. | |
| 14 | 00066714700155 | V8 | CADI | Cadi Software | Cadi | SYNCA MARKETING INC |
| 15 | 00046838076619 | CCL650i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 16 | 00046838076602 | CCL650i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 17 | 00046838076596 | CCL258i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 18 | 00046838076589 | CCL258i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 19 | 00046838076572 | CCL258i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 20 | 00046838076565 | MS25i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 21 | 00046838076558 | MS25i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 22 | 00046838076541 | MS25i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 23 | 00046838076534 | MS35i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 24 | 00046838076527 | MS35i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 25 | 00046838076510 | MS35i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 26 | 00046838076367 | CCL358i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 27 | 00046838076350 | CCL358i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 28 | 00035135013052 | CTR001305 | CTR001305 | GEL,ULTRASOUND,BOTTLE,8.5-OZ,CLEAR | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. |
| 29 | 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. | |
| 30 | 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. | |
| 31 | 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. | |
| 32 | 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. | |
| 33 | 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 | |
| 34 | 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 | |
| 35 | 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 | |
| 36 | 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 | |
| 37 | 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 | |
| 38 | 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 | |
| 39 | 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 | |
| 40 | 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 | |
| 41 | B80731 | Breast MRI SE | 3 | QuantX is a software program that is used to view and analyze patient breast images. | QuantX | QLARITY IMAGING, LLC |
| 42 | 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 |
| 43 | B801THINQ1130 | 1.1.3 | THINQ | CORTICOMETRICS LLC | ||
| 44 | B801THINQ1000 | 1.0.0 | THINQ | CORTICOMETRICS LLC | ||
| 45 | B7671R522 | 5.2.2 | Rapid | Rapid System Update | Rapid | ISCHEMAVIEW, INC. |
| 46 | B7671R521 | 5.2.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 47 | B7671R520 | 5.2.0 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 48 | B7671R512 | 5.1.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 49 | B7671R511 | 5.1.1 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 50 | B7671R5030 | 5.0.3 | Rapid | ISCHEMAVIEW, INC. |