No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00845225012915 | 797415 | 797415 | IYO,DSA,DSK | System, Imaging, Pulsed Echo, Ultrasonic,Cable, Transducer And Electrode, Patien System, Imaging, Pulsed Echo, Ultrasonic,Cable, Transducer And Electrode, Patient, (Including Connector),Computer, Blood-Pressure | 2 | IntraSight Mobile | |
2 | 00845225012823 | 409-1601.04 | DSA,DSK,IYO | Cable, Transducer And Electrode, Patient, (Including Connector),Computer, Blood- Cable, Transducer And Electrode, Patient, (Including Connector),Computer, Blood-Pressure,System, Imaging, Pulsed Echo, Ultrasonic | 2 | CORE Control Pad 2.0 | ||
3 | 00845225012809 | 410-3600.08 | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | CORE PC WORKSTATION FRU | ||
4 | 00845225012571 | 410-3600.05 | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | CORE Series Workstation | ||
5 | 00845225012496 | 409-0100.01 | DSK,DSA | Computer, Blood-Pressure,Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | FM-HUB | ||
6 | 00845225011420 | 891SV | 808884001 | IYO,OBJ | System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular | 2 | Patient Interface Module (PIMr) | |
7 | 00845225011239 | 807344001 | OBJ,IYO | Catheter, Ultrasound, Intravascular,System, Imaging, Pulsed Echo, Ultrasonic | 2 | s5 FFR Patient Interface Module | ||
8 | 00845225010256 | 410-3600.02 | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | CORE Series Workstation | ||
9 | 00845225010218 | 807400001 | IYO,OBJ | System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular | 2 | s5i Imaging System | ||
10 | 00845225002527 | 7024 | DTK | Filter, Intravascular, Cardiovascular | 2 | Crux® Vena Cava FIlter, Femoral | ||
11 | 00184360000198 | 1413 | DQX | Wire, Guide, Catheter | 2 | FloWire Doppler Guide Wire XT 300cm 014 ST | ||
12 | 00845225012748 | 411-0100.08 | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Connection Box II | ||
13 | 00845225012663 | 400-0100.17 | DSA,IYO | Cable, Transducer And Electrode, Patient, (Including Connector),System, Imaging, Cable, Transducer And Electrode, Patient, (Including Connector),System, Imaging, Pulsed Echo, Ultrasonic | 2 | CORE M2 Vascular System | ||
14 | 00845225010195 | 807300001 | OBJ,IYO | Catheter, Ultrasound, Intravascular,System, Imaging, Pulsed Echo, Ultrasonic | 2 | S5 IMAGING SYSTEM P/N 807300001 | ||
15 | 00845225010102 | 409-1601.01 | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | CORE Control Pad | ||
16 | 00184360000341 | 9500 | DQX | Wire, Guide, Catheter | 2 | ComboWire Pressure/Flow Guide Wire XT | ||
17 | 00845225012588 | 410-3600.06 | OBJ,IYO | Catheter, Ultrasound, Intravascular,System, Imaging, Pulsed Echo, Ultrasonic | 2 | s5i Imaging System Workstation | ||
18 | 00845225012076 | 409-1604.01 | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Control Console II | ||
19 | 00845225012038 | 807401200 | IYO,OBJ | System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular | 2 | s5i Imaging System Workstation | ||
20 | 00184360000686 | 807401001 | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | s5i Imaging System Workstation | ||
21 | 00184360000334 | 9515 | DQX | Wire, Guide, Catheter | 2 | ComboWire Pressure/Flow Guide Wrie XT 1.5cm Sensor | ||
22 | 00845225012670 | S18081AA | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | CORE Series Precision Guided Therapy System | ||
23 | 00845225012656 | 410-0100.11 | DSK,DSA | Computer, Blood-Pressure,Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | CORE FM CART | ||
24 | 00845225010874 | 6800 | 802745001 | OBJ,IYO | Catheter, Ultrasound, Intravascular,System, Imaging, Pulsed Echo, Ultrasonic | 2 | ComboMap Pressure and Flow System | |
25 | 00845225002534 | 7025 | DTK | Filter, Intravascular, Cardiovascular | 2 | Crux® Vena Cava FIlter, Jugular | ||
26 | 00845225012786 | 400-0100.18 | DSA,IYO | Cable, Transducer And Electrode, Patient, (Including Connector),System, Imaging, Cable, Transducer And Electrode, Patient, (Including Connector),System, Imaging, Pulsed Echo, Ultrasonic | 2 | CORE M2, Cart | ||
27 | 00845225012847 | 797416 | 797416 | DSK,DSA,IYO | Computer, Blood-Pressure,Cable, Transducer And Electrode, Patient, (Including Co Computer, Blood-Pressure,Cable, Transducer And Electrode, Patient, (Including Connector),System, Imaging, Pulsed Echo, Ultrasonic | 2 | FM-PIM | |
28 | 00845225012755 | 802143001 | OBJ,IYO | Catheter, Ultrasound, Intravascular,System, Imaging, Pulsed Echo, Ultrasonic | 2 | PIM, SYNTHETIC APERTURE W/PIGTAIL, s5 | ||
29 | 00845225012731 | 800573001-ROHS | DQX | Wire, Guide, Catheter | 2 | SmartMap Pressure System | ||
30 | 00845225012595 | 410-3600.07 | IYO,OBJ | System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular | 2 | s5i Imaging System Workstation | ||
31 | 00845225012489 | 409-0403.01 | DSA,DSK | Cable, Transducer And Electrode, Patient, (Including Connector),Computer, Blood-Pressure | 2 | FM-PIM | ||
32 | 00845225012045 | 807401215 | OBJ,IYO | Catheter, Ultrasound, Intravascular,System, Imaging, Pulsed Echo, Ultrasonic | 2 | s5i Imaging System Workstation | ||
33 | 00845225010935 | 891SV | 806071026 | IYO,OBJ | System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular | 2 | PIMr (SpinVision) Pullback Device | |
34 | 00845225010232 | 807400015 | OBJ,IYO | Catheter, Ultrasound, Intravascular,System, Imaging, Pulsed Echo, Ultrasonic | 2 | s5i Imaging System Workstation | ||
35 | 00845225010096 | 411-0100.01 | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Connection Box | ||
36 | 00184360000709 | 806302012 | OBJ,IYO | Catheter, Ultrasound, Intravascular,System, Imaging, Pulsed Echo, Ultrasonic | 2 | s5i Control Console | ||
37 | 00184360000204 | 1413J | DQX | Wire, Guide, Catheter | 2 | FloWire Doppler Guide Wire XT 300cm 014 JTIP | ||
38 | 00845225012830 | 300000467271 | OWB | Interventional Fluoroscopic X-Ray System | 2 | SyncVision Workstation | ||
39 | 00845225012472 | 400-0100.11 | DSA,DSK | Cable, Transducer And Electrode, Patient, (Including Connector),Computer, Blood-Pressure | 2 | CORE FM SYSTEM | ||
40 | 00845225012441 | 411-0100.04 | OWB | Interventional Fluoroscopic X-Ray System | 2 | SyncVision Workstation | ||
41 | 00845225011765 | 6805 | 802744001 | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | ComboMap patient Interface Module | |
42 | 00845225011109 | 806695004 | OBJ,IYO | Catheter, Ultrasound, Intravascular,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Joystick | ||
43 | 00845225011093 | 806695001 | IYO,OBJ | System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular | 2 | Joystick | ||
44 | 00845225012762 | 802143001-ROHS | IYO,OBJ | System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular | 2 | PIM, SYNTHETIC APERTURE W/PIGTAIL | ||
45 | 00845225012724 | 410-3600.09 | IYO,DSK,DSA | System, Imaging, Pulsed Echo, Ultrasonic,Computer, Blood-Pressure,Cable, Transdu System, Imaging, Pulsed Echo, Ultrasonic,Computer, Blood-Pressure,Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | CORE (W/X9 M/B), PC WORKSTATION FRU | ||
46 | 00845225012717 | 410-0100.16 | DSA,IYO | Cable, Transducer And Electrode, Patient, (Including Connector),System, Imaging, Cable, Transducer And Electrode, Patient, (Including Connector),System, Imaging, Pulsed Echo, Ultrasonic | 2 | CORE M2, Panel PC | ||
47 | 00845225012304 | 807301042 | OBJ,IYO | Catheter, Ultrasound, Intravascular,System, Imaging, Pulsed Echo, Ultrasonic | 2 | s5 PC Module | ||
48 | 00845225010317 | 5178027 | OBJ,IYO | Catheter, Ultrasound, Intravascular,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Joystick | ||
49 | 00184360000327 | R100 | 804547001 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | R-100 Pullback Device | |
50 | 00184360000167 | 1403J | DQX | Wire, Guide, Catheter | 2 | FloWire Doppler Guide Wire XT 175cm 014 JTIP |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00184360000709 | 806302012 | s5i Control Console | VOLCANO CORPORATION | ||
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 | 00184360000525 | 807301001 | s5 PC Module | VOLCANO CORPORATION | ||
6 | 00184360000358 | 89000 | Revolution 45MHz Rotational IVUS Imaging Catheter | PHILIPS IMAGE GUIDED THERAPY CORPORATION | ||
7 | 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. | |
8 | 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. | |
9 | 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. | |
10 | B616UVXS0 | XS | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
11 | B616UVXR0 | XR | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
12 | B616UVXP0 | XP | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
13 | B510DUS70000 | DUS-7000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
14 | B510DUS5000A1 | DUS-5000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
15 | B510DUS30001 | DUS-3000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
16 | B377GMD61VASUS40 | Vascular V4 | GMD61VASUS4 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
17 | B377GMD61ENDUS40 | Endocavity V4 | GMD61ENDUS4 | USB ultrasound probe, general purpose/endocavity. | ClearProbe | GLOBALMEDIA GROUP, LLC |
18 | B377GMD61ABDUS40 | Abdominal V4 | GMD61ABDUS4 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
19 | B377GMD6180NV010 | Neonatal | GMD6180NV01 | USB ultrasound probe, general purpose/neonatal | ClearProbe | GLOBALMEDIA GROUP, LLC |
20 | B377GMD6175VA010 | Vascular | GMD6175VA01 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
21 | B377GMD6175RV010 | Endocavity | GMD6175RV01 | USB ultrasound probe, general purpose/endocavity | ClearProbe | GLOBALMEDIA GROUP, LLC |
22 | B377GMD6150AB010 | Abdominal 5 MHz | GMD6150AB01 | USB ultrasound probe, general use/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
23 | B377GMD6135AB020 | Abdominal 3 MHz | GMD6135AB02 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
24 | B377GMD6135AB010 | Abdominal 3.5-5 MHz | GMD6135AB01 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
25 | B377GMD6112EY01 | Ophthalmic | GMD6112EY01 | USB ultrasound probe, general purpose/ophthalmic | ClearProbe | GLOBALMEDIA GROUP, LLC |
26 | B3015017750001 | Model 201 | 501775000 | SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ul SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ultrasound imaging Systems facilitating their use as an adjunct to mammography for B-mode ultrasonic screening imaging of the breast when used with a linear array transducer consisting of the following components: Image Acquisition Station Model 201 – PN 501775-000, Image Acquisition Station Software Application V3.1.x, PN 501642, Reading Station Software Application, V3.1.x, PN 501973. | SonoCine Image Acquisition Station | SONOCINE, INC. |
27 | B201CGONE0 | CGONE | Clear Guide ONE | CLEAR GUIDE MEDICAL, INC. | ||
28 | B201CGOHM0 | CGOHM | CG-OH-M | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | Clear Guide Optical Head | CLEAR GUIDE MEDICAL, INC. |
29 | B201CGOH0 | CGOH | CG-OH | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | Clear Guide Optical Head | CLEAR GUIDE MEDICAL, INC. |
30 | B201CGCORE170 | CGCORE17 | CG-CORE17 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
31 | B118314170 | Classic | Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series. | Sonocubic 3D Ultrasound Software | MEDGE PLATFORMS INC | |
32 | B118314160 | Classic | Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series. | Sonocubic 3D Ultrasound Software | MEDGE PLATFORMS INC | |
33 | B017ED102 | EyeSeal Disposable | ED1 | ArcScan Insight 100 | ARCSCAN, INC. | |
34 | B017AS100 | AS100 | AS100-120 | ArcScan Insight 100 | ARCSCAN, INC. | |
35 | B015000010 | 00001 | Accuro | RIVANNA MEDICAL, LLC | ||
36 | 90814277020127 | 21-05012-01 | Sterile Transducer Cover - individual cover in envelope | Sonic Window Sterile Transducer Cover | ANALOGIC CORPORATION | |
37 | 90814277020028 | 10-73868-02 | Replacement unit for Sonic Window Handheld Ultrasound System | Sonic Window Handheld Ultrasound Unit | ANALOGIC CORPORATION | |
38 | 90814277020011 | 10-73869-01 | Docking Station for Sonic Window Handheld Ultrasound System | Sonic Window Docking Station | ANALOGIC CORPORATION | |
39 | 90814277020004 | 10-73690-02 | The Sonic Window is intended for the visualization of vessels and vascular acces The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only. | Sonic Window Handheld Ultrasound System | ANALOGIC CORPORATION | |
40 | 60889971738837 | Touch Prime Ultrasound System | 1738830 | XE Edition | Touch Prime Ultrasound System | CARESTREAM HEALTH, INC. |
41 | 60889971738820 | Touch Prime Ultrasound System | 1738822 | Touch Prime Ultrasound System | Touch Prime Ultrasound System | CARESTREAM HEALTH, INC. |
42 | 58051887042642 | THD HRStation | 800299 | THD HRStation is an integrated proctological station mainly dedicated to the dia THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions.Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound. | THD Procto Software System | THD SPA |
43 | 40841716102552 | 017986 | HDi System Overpack p/n 800994-005Contents: System Console, Linear Translation S HDi System Overpack p/n 800994-005Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | ACIST HDi® HD IVUS System | ACIST MEDICAL SYSTEMS, INC. | |
44 | 40841716102101 | 016375 | ACI Hardware, HDi System p/n 801085-001Contents: ACI Hardware | ACIST HDi® HD IVUS System | ACIST MEDICAL SYSTEMS, INC. | |
45 | 40841716102057 | 016323 | HDi System Overpack, with ACIST Connect, JAPAN p/n 801081-001Contents: System Co HDi System Overpack, with ACIST Connect, JAPAN p/n 801081-001Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply, ACI Hardware | ACIST HDi® HD IVUS System | ACIST MEDICAL SYSTEMS, INC. | |
46 | 40841716101982 | 017986 | HDi System Overpack p/n 801029-002Contents: System Console, Linear Translation S HDi System Overpack p/n 801029-002Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | ACIST HDi® HD IVUS System | ACIST MEDICAL SYSTEMS, INC. | |
47 | 40841716101869 | 017986 | HDi System Overpack p/n 800994-004Contents: System Console, Linear Translation S HDi System Overpack p/n 800994-004Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | ACIST HDi® HD IVUS System | ACIST MEDICAL SYSTEMS, INC. | |
48 | 40841716101180 | 017986 | HDi System Overpack p/n 800994-002Contents: System Console, Linear Translation S HDi System Overpack p/n 800994-002Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | ACIST HDi® HD IVUS System | ACIST MEDICAL SYSTEMS, INC. | |
49 | 40841716100749 | 017986 | HDi System Overpack p/n 801029-001Contents: System Console, Linear Translation S HDi System Overpack p/n 801029-001Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | ACIST HDi® HD IVUS System | ACIST MEDICAL SYSTEMS, INC. | |
50 | 40841716100251 | 017986 | HDi System Overpack p/n 800994-003Contents: System Console, Linear Translation S HDi System Overpack p/n 800994-003Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | ACIST HDi® HD IVUS System | ACIST MEDICAL SYSTEMS, INC. |