No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850681007191 | NA-DSP2 | NA-DSP2 | The NovaKit contains the following single use items; probe pod covers, head crad The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots. | ITX,IYN,OQQ | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic,D Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic,Diagnostic Ultrasonic Transducer, Robotic | 2 | NovaKit Exam Pack (NovaKit) |
2 | 00850681007122 | 1.x | NA-RBT1 | The NeuralBot System is a cart mounted, robotic transcranial Doppler (TCD) probe The NeuralBot System is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid M1 System (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) and the occurrence of transient emboli within the blood stream, via the patient’s temporal acoustic windows. | IYN,ITX,OQQ | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,D System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Diagnostic Ultrasonic Transducer, Robotic | 2 | NeuralBot |
3 | 00850681007023 | 40-00009 | NA - PRB2 | The monitoring transducer is a 2 MHz single-element ultrasound transducer design The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity measurements.The transducer has the following specifications:• 2MHz ± 0.1MHz center frequency• 46mm ± 5mm focal length• 16mm active diameter• Fractional 6dB pulse-echo bandwidth = 60% to 80%• Round-trip insertion loss < 6dB• Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase | ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2-MHz Headset/Monitoring Transducer |
4 | 00850681007221 | NA-LUCM1 | NA-LUCM1 | The Lucid TCD is a medical ultrasound system intended for use as an adjunct to t The Lucid TCD is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity (CBFV) within the major conducting arteries and veins of the head and neck. Additionally, the Lucid TCD measures the occurrence of transient emboli signals within the blood stream.The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. | ITX,IYN | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Lucid Transcranial Doppler Ultrasound System (Lucid TCD) |
5 | 00850681007184 | NA-RBT1 | NA-RBT1 | NovaBot Automated Headset accessory for the Lucid TCD. When connected to the Luc NovaBot Automated Headset accessory for the Lucid TCD. When connected to the Lucid TCD, the combined device is referred to as the NovaGuide.The NovaBot is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid TCD (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) and the occurrence of transient emboli within the blood stream, via the patient's temporal acoustic windows. | IYN,ITX,OQQ | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,D System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Diagnostic Ultrasonic Transducer, Robotic | 2 | NovaBot Automated Headset |
6 | 00850681007177 | NA-DSP3 | NA-DSP3 | Procedural set that includes replacement foam for the monitoring headframe. | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Monitoring Headframe Foam Procedural Set |
7 | 00850681007047 | 10-00002 | NA-ACC2 | The Remote Control Accessory is an optional accessory device designed to replica The Remote Control Accessory is an optional accessory device designed to replicate the touch screen interface for commonly used commands during exams. | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Remote Control Accessory |
8 | 00850681007160 | NA-MOUNT2 | NA-MOUNT2 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Temporal Monitoring Headframe | |
9 | 00850681007283 | 25-00004 | NSC-NVK | IYN,ITX | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | NovaKit™ 2 Exam Pack | |
10 | 00850681007153 | NA-PRB3 | NA-PRB3 | The monitoring transducer is a 2 MHz single-element ultrasound transducer design The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity measurements.The transducer has the following specifications:• 2MHz ± 0.1MHz center frequency• 46mm ± 5mm focal length• 16mm active diameter• Fractional 6dB pulse-echo bandwidth = 60% to 80%• Round-trip insertion loss < 6dB• Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase | ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2Mhz Monitoring Transducer - 8 foot |
11 | 00850681007443 | 05-00019 | NA-RBTSYS1 | IYN,ITX,OQQ | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,D System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Diagnostic Ultrasonic Transducer, Robotic | 2 | NovaGuide™ Intelligent Ultrasound System | |
12 | 00850681007115 | 1.x | NA-DSP2 | The NeuralBot procedural set contains the following single use items; probe pod The NeuralBot procedural set contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots. | ITX,OQQ,IYN | Transducer, Ultrasonic, Diagnostic,Diagnostic Ultrasonic Transducer, Robotic,Sys Transducer, Ultrasonic, Diagnostic,Diagnostic Ultrasonic Transducer, Robotic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | NeuralBot Procedural Set (Single Use) |
13 | 00850681007399 | 05-00030 | NSC-NVGSYS2 | IYN,ITX | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | NovaGuide™ 2 Intelligent Ultrasound System | |
14 | 00850681007016 | 40-00008 | NA – PRB1 | The handheld transducer is a 2 MHz single-element ultrasound transducer designed The handheld transducer is a 2 MHz single-element ultrasound transducer designed to be held by hand to perform velocity measurements.The transducer has the following specifications:• 2MHz ± 0.1MHz center frequency• 46mm ± 5mm focal length• 16mm active diameter• Fractional 6dB pulse-echo bandwidth = 60% to 80%• Round-trip insertion loss < 6dB• Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase | ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2-MHz Transducer, Handheld |
15 | 00850681007009 | M1 | NA – LUCM1 | ITX,IYN | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Lucid Transcranial Doppler System | |
16 | 00850681007405 | NSC-TCDNG2 | NSC-TCDNG2 | IYN,ITX | System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | NovaGuide™ 2 Traditional Ultrasound System | |
17 | 00850681007030 | 40-00010 | NA – MOUNT1 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Temporal Monitoring Headset |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | EAMITRI20700 | TRI2070 | TRI2070 | The Wi-3 Arm is used to fix the outer (white) HAL-RAR sleeve in place to enhance The Wi-3 Arm is used to fix the outer (white) HAL-RAR sleeve in place to enhance gradual opening of the RAR window when mucopexy is performed, allowing the surgeon, the nurse or any assistant to comfortably hold the system in position.The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary. | Wi-3 Arm | AMI AGENCY FOR MEDICAL INNOVATIONS GMBH |
2 | EAMITRI20100 | TRI2010 | TRI2010 | Electronic unit for identifying the localised haemorrhoidal arteries by means of Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the Wi-3 HAL-RAR System.The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary. | Wi-3 HAL-RAR Unit | AMI AGENCY FOR MEDICAL INNOVATIONS GMBH |
3 | EAMIRAR20810 | RAR2081 | RAR2081 | RAR Flexi Probe | AMI AGENCY FOR MEDICAL INNOVATIONS GMBH | |
4 | EAMIRAR20110 | RAR 2011 | RAR 2011 | A.M.I. Recto Anal Repair Probe | AMI AGENCY FOR MEDICAL INNOVATIONS GMBH | |
5 | EAMIAHH0010 | AHH 001 | AHH 001 | Handle for the HAL/RAR probes. | A.M.I. HAL Handle | AMI AGENCY FOR MEDICAL INNOVATIONS GMBH |
6 | EAMIAHE2030 | AHE 203 | AHE 203 | Electronic unit for identifying the localised haemorrhoidal arteries by means of Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the A.M.I. HAL/RAR System.The A.M.I. HAL-II Electronic System is a Doppler-based device. It is powered by a DC voltage source (rechargeable batteries or 12 V adapter). The A.M.I. HAL-II Electronic System generates electrical signals, calculates differences between the wavelength of outgoing and reflected electrical signals, and generates an acoustic Doppler signal.Together with auxiliary A.M.I. devices (A.M.I. HAL Handle, Probe and Sleeve) the A.M.I. HAL-II Electronic System serves for the detection of haemorrhoidal arteries and enables manual ligation of detected arteries, as well as mucopexy of prolapsing haemorrhoidal mucosa. | A.M.I. HAL-II Electronic System | AMI AGENCY FOR MEDICAL INNOVATIONS GMBH |
7 | EAMIAHA0030 | AHA 003 | AHA 003 | A.M.I. HAL-II Adaptor USA | AMI AGENCY FOR MEDICAL INNOVATIONS GMBH | |
8 | 00885554034882 | 72204325 | 72204325 | HAT-TRICK MTP UNILATERAL PROC PACK | HAT-TRICK | SMITH & NEPHEW, INC. |
9 | 00884838114470 | 795186 | Software Version 6.X | Affiniti 70C Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
10 | 00884838114470 | 795186 | Software Version 6.X | Affiniti 70C Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
11 | 00884838114463 | 795185 | Software Version 6.X | Affiniti 70W Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
12 | 00884838114463 | 795185 | Software Version 6.X | Affiniti 70W Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
13 | 00884838114456 | 795187 | Software Version 6.X | Affiniti 70 Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
14 | 00884838114456 | 795187 | Software Version 6.X | Affiniti 70 Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
15 | 00884838113961 | 795125 | Software Version 9.x | EPIQ Elite Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
16 | 00884838113961 | 795125 | Software Version 9.x | EPIQ Elite Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
17 | 00884838113947 | 795123 | Software version 4.X | Lumify Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
18 | 00884838113947 | 795123 | Software version 4.X | Lumify Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
19 | 00884838113930 | 795123 | Software version 3.x | Lumify Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
20 | 00884838113930 | 795123 | Software version 3.x | Lumify Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
21 | 00884838113923 | 795122 | Software Version 9.x | EPIQ CVx Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
22 | 00884838113923 | 795122 | Software Version 9.x | EPIQ CVx Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
23 | 00884838113916 | 795122 | Software version 7.x | EPIQ CVx Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
24 | 00884838113916 | 795122 | Software version 7.x | EPIQ CVx Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
25 | 00884838113909 | 795121 | Software version 9.X | Affiniti 30 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
26 | 00884838113909 | 795121 | Software version 9.X | Affiniti 30 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
27 | 00884838113893 | 795121 | Software version 7.x | Affiniti 30 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
28 | 00884838113893 | 795121 | Software version 7.x | Affiniti 30 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
29 | 00884838113886 | 795120 | Software Version 9.X | EPIQ 5 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
30 | 00884838113886 | 795120 | Software Version 9.X | EPIQ 5 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
31 | 00884838113862 | 795119 | Software version 9.X | Affiniti 70 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
32 | 00884838113862 | 795119 | Software version 9.X | Affiniti 70 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
33 | 00884838113855 | 795119 | Software version 7.x | Affiniti 70 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
34 | 00884838113855 | 795119 | Software version 7.x | Affiniti 70 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
35 | 00884838113848 | 795118 | 9.X | Affiniti 50 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
36 | 00884838113848 | 795118 | 9.X | Affiniti 50 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
37 | 00884838113831 | 795118 | Software Version 7.X | Affiniti 50 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
38 | 00884838113831 | 795118 | Software Version 7.X | Affiniti 50 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
39 | 00884838113824 | 795117 | Software Version 9.X | EPIQ 7 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
40 | 00884838113824 | 795117 | Software Version 9.X | EPIQ 7 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
41 | 00884838113800 | 795116 | Software version 3.X | Sparq Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
42 | 00884838113800 | 795116 | Software version 3.X | Sparq Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
43 | 00884838113794 | 795116 | Software version 2.X | Sparq Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
44 | 00884838113794 | 795116 | Software version 2.X | Sparq Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
45 | 00884838113787 | 795114 | Software version 5.X | CX50 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
46 | 00884838113787 | 795114 | Software version 5.X | CX50 Ultrasound Circular Edition | PHILIPS ULTRASOUND, INC. | |
47 | 00884838111004 | 795258 | Software version 6.X | EPIQ Elite W Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
48 | 00884838111004 | 795258 | Software version 6.X | EPIQ Elite W Diagnostic Ultrasound System | PHILIPS ULTRASOUND, INC. | |
49 | 00884838109971 | 795125 | To support the 7.x software version | EPIQ Elite Diamond Select Ultrasound | PHILIPS ULTRASOUND, INC. | |
50 | 00884838109971 | 795125 | To support the 7.x software version | EPIQ Elite Diamond Select Ultrasound | PHILIPS ULTRASOUND, INC. |