No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00812059021383 | OPTIS™ E.2 Software | C408656 | Software Upgrade Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | ILUMIEN™ |
2 | 00812059020560 | D.1.1 Software | 100111860 | Software Upgrade Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | ILUMIEN™ |
3 | 00183739000678 | C408650 | C408650 | Imaging System | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | ILUMIEN™ |
4 | 00183739000630 | 900-700-00 | 900-700-00 | Imaging System | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | ILUMIEN™ |
5 | 00183739000562 | 100-100-00 | 100-100-00 | Imaging Catheter | ORD | Optical coherence tomography, intravascular catheter | 2 | C7 Dragonfly™ |
6 | 00183739000708 | Duo | C408644 | Imaging Catheter | ORD | Optical coherence tomography, intravascular catheter | 2 | Dragonfly™ |
7 | 00183739000692 | Duo Kit | C408643 | Imaging Catheter | ORD | Optical coherence tomography, intravascular catheter | 2 | Dragonfly™ |
8 | 00183739000654 | C408646 | C408646 | Imaging Catheter | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | 2 | Dragonfly™ |
9 | 00183739000647 | C408645 | C408645 | Imaging Catheter | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | 2 | Dragonfly™ |
10 | 00183739000623 | Kit | 100-100-KT | Imaging Catheter | ORD | Optical coherence tomography, intravascular catheter | 2 | Dragonfly™ |
11 | 00812059021536 | C.0.4 Software Upgrade | 15211-01 | Software Upgrade Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | C7-XR™ |
12 | 00812059021338 | D.2 Software | C408660 | NQQ,DQO | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT),CATHETER, INTRAVASCULAR, DIAGNOSTIC | 2 | Ilumien™ | |
13 | 00812059021994 | Mobile System | C408667 | Installation Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
14 | 00812059021987 | Mobile System | C408666 | Installation Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
15 | 00812059021925 | Software Upgrade | E4-STD-WW | Software Upgrade | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
16 | 00812059021918 | Metallic Stent Optimization Software | E4-FULL-WW | Software Upgrade | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
17 | 00812059021444 | C408663 | C408663 | Tableside Controller | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
18 | 00812059021437 | Mobile System | C408662 | Upgrade Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
19 | 00812059021420 | Mobile System | C408661 | Imaging System | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
20 | 00812059021390 | Integrated System E.2 Software | C408657 | Software Upgrade Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
21 | 00812059020126 | C408653 | C408653 | Mobile Workstation | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
22 | 00812059020003 | Integrated System | C408654 | Installation Kit | NQQ,DQO | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT),CATHETER, INTRAVASCULAR, DIAGNOSTIC | 2 | OPTIS™ |
23 | 00183739000937 | Integrated System | C408652 | Imaging System | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
24 | 05415067030856 | 1014666 | 1014666 | Software Upgrade Kit | NQQ,DQO | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT),CATHETER, INTRAVASCULAR, DIAGNOSTIC | 2 | AptiVue™ |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 05415067045331 | 1015191 | 1015191 | 1.0 Software Update vF.0.1 | Ultreon™ | ST. JUDE MEDICAL, INC. |
2 | 05415067037558 | 1014932 | 1014932 | Imaging System | OPTIS™ | ST. JUDE MEDICAL, INC. |
3 | 05415067037268 | 1014943 | 1014943 | Integrated Pre-Installation Kit | OPTIS™ | ST. JUDE MEDICAL, INC. |
4 | 05415067037183 | 1014945 | 1014945 | Mobile Next Connectivity Box FRU | OPTIS™ | ST. JUDE MEDICAL, INC. |
5 | 05415067037169 | 1014944 | 1014944 | Mobile Installation Kit | OPTIS™ | ST. JUDE MEDICAL, INC. |
6 | 05415067037145 | 1014933 | 1014933 | Integrated Next Imaging System | OPTIS™ | ST. JUDE MEDICAL, INC. |
7 | 05415067036858 | 1014935 | 1014935 | Integrated Next Upgrade Kit | OPTIS™ | ST. JUDE MEDICAL, INC. |
8 | 05415067036810 | 1014941 | 1014941 | Next Doc Holster FRU | OPTISi™ | ST. JUDE MEDICAL, INC. |
9 | 05415067036742 | 1014934 | 1014934 | Mobile Next Upgrade Kit | OPTIS™ | ST. JUDE MEDICAL, INC. |
10 | 05415067036728 | 1014942 | 1014942 | OPTISi Next Monitor | OPTIS™ | ST. JUDE MEDICAL, INC. |
11 | 05415067036704 | 1014940 | 1014940 | OPTISi Next DOC | OPTIS™ | ST. JUDE MEDICAL, INC. |
12 | 05415067036681 | 1014939 | 1014939 | OPTISm Next DOC | OPTIS™ | ST. JUDE MEDICAL, INC. |
13 | 05415067036643 | 1014938 | 1014938 | Integrated Next | OPTIS™ | ST. JUDE MEDICAL, INC. |
14 | 05415067036629 | 1014937 | 1014937 | Mobile Next | OPTIS™ | ST. JUDE MEDICAL, INC. |
15 | 05415067033680 | 1014936 | 1014936 | Tableside Controller Next | OPTIS™ | ST. JUDE MEDICAL, INC. |
16 | 05415067030856 | 1014666 | 1014666 | Software Upgrade Kit | AptiVue™ | LIGHTLAB IMAGING, INC. |
17 | 05415067030108 | 1014661 | 1014661 | Software Upgrade Kit | AptiVue™ | ST. JUDE MEDICAL, INC. |
18 | 05415067027764 | Monitor Cable | C12978 | Monitor Cable | SJM™ | ST. JUDE MEDICAL, INC. |
19 | 05060507260012 | VivoSight Dx | The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, r The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.This indicated use allows imaging of tissue microstructure including skin, and enables detection and display of regions within the scanned area that are in motion (Dynamic OCT) to aid trained and competent clinicians in their assessment of a patient's clinical conditions. | VivoSight | MICHELSON DIAGNOSTICS LTD | |
20 | 05060507260005 | VivoSight | The VivoSight Topical OCT system is indicated for use in the two-dimensional, cr The VivoSight Topical OCT system is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.This indicated use allows imaging of tissue microstructure, including skin, to aid trained and competent clinicians in their assessment of a patient's clinical conditions. | VivoSight | MICHELSON DIAGNOSTICS LTD | |
21 | 04719878880008 | S100-000US | ApolloVue S100 Image System | APOLLO MEDICAL OPTICS, LTD. | ||
22 | 00859910007049 | Gentuity Review Station | G80-01 | Gentuity Off-line Review Station includes computer, monitor, keyboard, and mouse. | Gentuity | GENTUITY LLC |
23 | 00859910007032 | Gentuity Imaging System G10-01 K192922 | Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse. | Gentuity HF-OCT Imaging System | GENTUITY LLC | |
24 | 00859591006270 | 94301-MI-UPG-R | NvisionVLE Marking Console with IRIS, Upgraded, Refurbished | NINEPOINT MEDICAL, INC. | ||
25 | 00859591006263 | 94301-MI-UPG | NvisionVLE Marking Console with IRIS, Upgraded | NINEPOINT MEDICAL, INC. | ||
26 | 00859591006256 | 94301-MI-R | 94301-MI-R | NvisionVLE Marking Console with IRIS, Refurbished | NINEPOINT MEDICAL, INC. | |
27 | 00859591006249 | 94301-MI | 94301-MI | NvisionVLE Marking Console with IRIS | NINEPOINT MEDICAL, INC. | |
28 | 00859591006232 | 96101-60 | 96101-60 | NvisionVLE Inflation Kit | NINEPOINT MEDICAL, INC. | |
29 | 00859591006225 | 94301-M-UPG-R | 94301-M-UPG-R | NvisionVLE Marking Upgrade Refurbished | NINEPOINT MEDICAL, INC. | |
30 | 00859591006218 | 94301-M-UPG | 94301-M-UPG | NvisionVLE Imaging System with Targeted Biopsy - Upgrade | NINEPOINT MEDICAL, INC. | |
31 | 00859591006201 | 95501-20 | 95501-20 | NvisionVLE Low Profile Imaging Probe, 20mm Working Distance | NINEPOINT MEDICAL, INC. | |
32 | 00859591006195 | 95501-14 | 95501-14 | NvisionVLE Low Profile Imaging Probe, 14mm Working Distance | NINEPOINT MEDICAL, INC. | |
33 | 00859591006188 | 95501-LP | 95501-LP | NvisionVLE Low Profile Imaging Probe, 0mm Working Distance | NINEPOINT MEDICAL, INC. | |
34 | 00859591006171 | 95101-14C | 95101-14C | NvisionVLE Imaging Probe 14mm Clinical | NINEPOINT MEDICAL, INC. | |
35 | 00859591006164 | 95101-20C | 95101-20C | NvisionVLE Imaging Probe 20mm Clinical | NINEPOINT MEDICAL, INC. | |
36 | 00859591006157 | 95101-17C | 95101-17C | NvisionVLE Imaging Probe 17mm Clinical | NINEPOINT MEDICAL, INC. | |
37 | 00859591006140 | 95301-M-14C | 95301-M-14C | NvisionVLE Marking Probe 14mm Clinical | NINEPOINT MEDICAL, INC. | |
38 | 00859591006133 | 95301-M-20C | 95301-M-20C | NvisionVLE Marking Probe 20mm Clinical | NINEPOINT MEDICAL, INC. | |
39 | 00859591006126 | 95301-M-17C | 95301-M-17C | NvisionVLE Marking Probe 17mm Clinical | NINEPOINT MEDICAL, INC. | |
40 | 00859591006119 | 94301-M-R | 94301-M-R | NvisionVLE Marking Console Refurbished | NINEPOINT MEDICAL, INC. | |
41 | 00859591006102 | 94301-M | 94301-M | NvisionVLE Marking Console | NINEPOINT MEDICAL, INC. | |
42 | 00859591006096 | 94101-R | 94101-R | NvisionVLE Imaging Console Refurbished | NINEPOINT MEDICAL, INC. | |
43 | 00859591006089 | 94101 | 94101 | NvisionVLE Imaging Console | NINEPOINT MEDICAL, INC. | |
44 | 00859591006072 | 95301-M-20 | 95301-M-20 | NvisionVLE Marking Probe 20mm | NINEPOINT MEDICAL, INC. | |
45 | 00859591006065 | 95301-M-17 | 95301-M-17 | NvisionVLE Marking Probe 17mm | NINEPOINT MEDICAL, INC. | |
46 | 00859591006058 | 95301-M-14 | 95301-M-14 | NvisionVLE Marking Probe 14mm | NINEPOINT MEDICAL, INC. | |
47 | 00859591006041 | 95101-20 | 95101-20 | NvisionVLE Imaging Probe 20mm | NINEPOINT MEDICAL, INC. | |
48 | 00859591006034 | 95101-17 | 95101-17 | NvisionVLE Imaging Probe 17mm | NINEPOINT MEDICAL, INC. | |
49 | 00859591006027 | 95101-14 | 95101-14 | NvisionVLE Imaging Probe 14mm | NINEPOINT MEDICAL, INC. | |
50 | 00851354004417 | A140-SV | A140-SV | The Pantheris SV System is intended to remove plaque (atherectomy) from partiall The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. | Pantheris SV | AVINGER, INC. |