No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00859591006249 | 94301-MI | 94301-MI | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Console with IRIS | |
2 | 00859591006195 | 95501-14 | 95501-14 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Low Profile Imaging Probe, 14mm Working Distance | |
3 | 00859591006096 | 94101-R | 94101-R | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Console Refurbished | |
4 | 00859591006065 | 95301-M-17 | 95301-M-17 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 17mm | |
5 | 00859591006270 | 94301-MI-UPG-R | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Console with IRIS, Upgraded, Refurbished | ||
6 | 00859591006225 | 94301-M-UPG-R | 94301-M-UPG-R | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Upgrade Refurbished | |
7 | 00859591006218 | 94301-M-UPG | 94301-M-UPG | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging System with Targeted Biopsy - Upgrade | |
8 | 00859591006171 | 95101-14C | 95101-14C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Probe 14mm Clinical | |
9 | 00859591006164 | 95101-20C | 95101-20C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Probe 20mm Clinical | |
10 | 00859591006034 | 95101-17 | 95101-17 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Probe 17mm | |
11 | 00859591006263 | 94301-MI-UPG | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Console with IRIS, Upgraded | ||
12 | 00859591006133 | 95301-M-20C | 95301-M-20C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 20mm Clinical | |
13 | 00859591006058 | 95301-M-14 | 95301-M-14 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 14mm | |
14 | 00859591006188 | 95501-LP | 95501-LP | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Low Profile Imaging Probe, 0mm Working Distance | |
15 | 00859591006201 | 95501-20 | 95501-20 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Low Profile Imaging Probe, 20mm Working Distance | |
16 | 00859591006126 | 95301-M-17C | 95301-M-17C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 17mm Clinical | |
17 | 00859591006102 | 94301-M | 94301-M | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Console | |
18 | 00859591006027 | 95101-14 | 95101-14 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Probe 14mm | |
19 | 00859591006232 | 96101-60 | 96101-60 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | NvisionVLE Inflation Kit | ||
20 | 00859591006157 | 95101-17C | 95101-17C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Probe 17mm Clinical | |
21 | 00859591006119 | 94301-M-R | 94301-M-R | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Console Refurbished | |
22 | 00859591006072 | 95301-M-20 | 95301-M-20 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 20mm | |
23 | 00859591006140 | 95301-M-14C | 95301-M-14C | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Marking Probe 14mm Clinical | |
24 | 00859591006089 | 94101 | 94101 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Console | |
25 | 00859591006041 | 95101-20 | 95101-20 | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | NvisionVLE Imaging Probe 20mm |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00812059021994 | Mobile System | C408667 | Installation Kit | OPTIS™ | LIGHTLAB IMAGING, INC. |
2 | 00812059021987 | Mobile System | C408666 | Installation Kit | OPTIS™ | LIGHTLAB IMAGING, INC. |
3 | 00812059021925 | Software Upgrade | E4-STD-WW | Software Upgrade | OPTIS™ | LIGHTLAB IMAGING, INC. |
4 | 00812059021918 | Metallic Stent Optimization Software | E4-FULL-WW | Software Upgrade | OPTIS™ | LIGHTLAB IMAGING, INC. |
5 | 00812059021536 | C.0.4 Software Upgrade | 15211-01 | Software Upgrade Kit | C7-XR™ | LIGHTLAB IMAGING, INC. |
6 | 00812059021482 | D.1 Software | 100074942 | Software Upgrade Kit | ILUMIEN™ | LIGHTLAB IMAGING, INC. |
7 | 00812059021444 | C408663 | C408663 | Tableside Controller | OPTIS™ | LIGHTLAB IMAGING, INC. |
8 | 00812059021437 | Mobile System | C408662 | Upgrade Kit | OPTIS™ | LIGHTLAB IMAGING, INC. |
9 | 00812059021420 | Mobile System | C408661 | Imaging System | OPTIS™ | LIGHTLAB IMAGING, INC. |
10 | 00812059021390 | Integrated System E.2 Software | C408657 | Software Upgrade Kit | OPTIS™ | LIGHTLAB IMAGING, INC. |
11 | 00812059021383 | OPTIS™ E.2 Software | C408656 | Software Upgrade Kit | ILUMIEN™ | LIGHTLAB IMAGING, INC. |
12 | 00812059021338 | D.2 Software | C408660 | Ilumien™ | LIGHTLAB IMAGING, INC. | |
13 | 00812059020560 | D.1.1 Software | 100111860 | Software Upgrade Kit | ILUMIEN™ | LIGHTLAB IMAGING, INC. |
14 | 00812059020126 | C408653 | C408653 | Mobile Workstation | OPTIS™ | LIGHTLAB IMAGING, INC. |
15 | 00812059020003 | Integrated System | C408654 | Installation Kit | OPTIS™ | LIGHTLAB IMAGING, INC. |
16 | 00754016215049 | PMI001OCT21 | ASY-2000 | The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imag | S-Series OCT | PERIMETER MEDICAL IMAGING AI, INC. |
17 | 00754016215025 | PMI010CON21 | ASY-2600 | The OTIS 2.1 system includes a single-use specimen container, the Consumable Set | Specimen Immobilizer | PERIMETER MEDICAL IMAGING AI, INC. |
18 | 00754016215018 | PMI001OCT21 | ASY-2000 | The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imag | THiA | PERIMETER MEDICAL IMAGING AI, INC. |
19 | 00628055603108 | SA-10-0029 | Imaging catheter accessories | Novasight Hybrid™ Catheter PIM Bag | CONAVI MEDICAL INC | |
20 | 00628055603085 | TA-07-0001 | Imaging System | Novasight Hybrid™ PIM | CONAVI MEDICAL INC | |
21 | 00628055603078 | TA-03-0005 | Imaging System | Novasight Hybrid™ Hummingbird Console | CONAVI MEDICAL INC | |
22 | 00628055603061 | SA-10-0022 | Imaging catheter accessories | Novasight Hybrid™ Catheter Accessories Package | CONAVI MEDICAL INC | |
23 | 00628055603054 | TA-06-0001 | Imaging catheter | Novasight Hybrid™ Catheter | CONAVI MEDICAL INC | |
24 | 00183739000937 | Integrated System | C408652 | Imaging System | OPTIS™ | LIGHTLAB IMAGING, INC. |
25 | 00183739000678 | C408650 | C408650 | Imaging System | ILUMIEN™ | LIGHTLAB IMAGING, INC. |
26 | 00183739000630 | 900-700-00 | 900-700-00 | Imaging System | ILUMIEN™ | LIGHTLAB IMAGING, INC. |
27 | 00041520113429 | 055544 | Care One | AHOLD U.S.A., INC. | ||
28 | 05415067045331 | 1015191 | 1015191 | 1.0 Software Update vF.0.1 | Ultreon™ | ST. JUDE MEDICAL, INC. |
29 | 05415067037558 | 1014932 | 1014932 | Imaging System | OPTIS™ | ST. JUDE MEDICAL, INC. |
30 | 05415067037268 | 1014943 | 1014943 | Integrated Pre-Installation Kit | OPTIS™ | ST. JUDE MEDICAL, INC. |
31 | 05415067037183 | 1014945 | 1014945 | Mobile Next Connectivity Box FRU | OPTIS™ | ST. JUDE MEDICAL, INC. |
32 | 05415067037169 | 1014944 | 1014944 | Mobile Installation Kit | OPTIS™ | ST. JUDE MEDICAL, INC. |
33 | 05415067037145 | 1014933 | 1014933 | Integrated Next Imaging System | OPTIS™ | ST. JUDE MEDICAL, INC. |
34 | 05415067036858 | 1014935 | 1014935 | Integrated Next Upgrade Kit | OPTIS™ | ST. JUDE MEDICAL, INC. |
35 | 05415067036810 | 1014941 | 1014941 | Next Doc Holster FRU | OPTISi™ | ST. JUDE MEDICAL, INC. |
36 | 05415067036742 | 1014934 | 1014934 | Mobile Next Upgrade Kit | OPTIS™ | ST. JUDE MEDICAL, INC. |
37 | 05415067036728 | 1014942 | 1014942 | OPTISi Next Monitor | OPTIS™ | ST. JUDE MEDICAL, INC. |
38 | 05415067036704 | 1014940 | 1014940 | OPTISi Next DOC | OPTIS™ | ST. JUDE MEDICAL, INC. |
39 | 05415067036681 | 1014939 | 1014939 | OPTISm Next DOC | OPTIS™ | ST. JUDE MEDICAL, INC. |
40 | 05415067036643 | 1014938 | 1014938 | Integrated Next | OPTIS™ | ST. JUDE MEDICAL, INC. |
41 | 05415067036629 | 1014937 | 1014937 | Mobile Next | OPTIS™ | ST. JUDE MEDICAL, INC. |
42 | 05415067033680 | 1014936 | 1014936 | Tableside Controller Next | OPTIS™ | ST. JUDE MEDICAL, INC. |
43 | 05415067030856 | 1014666 | 1014666 | Software Upgrade Kit | AptiVue™ | LIGHTLAB IMAGING, INC. |
44 | 05415067030108 | 1014661 | 1014661 | Software Upgrade Kit | AptiVue™ | ST. JUDE MEDICAL, INC. |
45 | 05415067027764 | Monitor Cable | C12978 | Monitor Cable | SJM™ | ST. JUDE MEDICAL, INC. |
46 | 05060507260012 | VivoSight Dx | The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, r | VivoSight | MICHELSON DIAGNOSTICS LTD | |
47 | 05060507260005 | VivoSight | The VivoSight Topical OCT system is indicated for use in the two-dimensional, cr | VivoSight | MICHELSON DIAGNOSTICS LTD | |
48 | 04719878880008 | S100-000US | ApolloVue S100 Image System | APOLLO MEDICAL OPTICS, LTD. | ||
49 | 00859910007049 | Gentuity Review Station | G80-01 | Gentuity Off-line Review Station includes computer, monitor, keyboard, and mouse. | Gentuity | GENTUITY LLC |
50 | 00859910007032 | Gentuity Imaging System G10-01 K192922 | Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, | Gentuity HF-OCT Imaging System | GENTUITY LLC |