No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00812059021482 | D.1 Software | 100074942 | Software Upgrade Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | ILUMIEN™ |
2 | 00812059021383 | OPTIS™ E.2 Software | C408656 | Software Upgrade Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | ILUMIEN™ |
3 | 00812059020560 | D.1.1 Software | 100111860 | Software Upgrade Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | ILUMIEN™ |
4 | 00183739000678 | C408650 | C408650 | Imaging System | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | ILUMIEN™ |
5 | 00183739000630 | 900-700-00 | 900-700-00 | Imaging System | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | ILUMIEN™ |
6 | 00183739000562 | 100-100-00 | 100-100-00 | Imaging Catheter | ORD | Optical coherence tomography, intravascular catheter | 2 | C7 Dragonfly™ |
7 | 00183739000708 | Duo | C408644 | Imaging Catheter | ORD | Optical coherence tomography, intravascular catheter | 2 | Dragonfly™ |
8 | 00183739000692 | Duo Kit | C408643 | Imaging Catheter | ORD | Optical coherence tomography, intravascular catheter | 2 | Dragonfly™ |
9 | 00183739000654 | C408646 | C408646 | Imaging Catheter | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | 2 | Dragonfly™ |
10 | 00183739000647 | C408645 | C408645 | Imaging Catheter | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | 2 | Dragonfly™ |
11 | 00183739000623 | Kit | 100-100-KT | Imaging Catheter | ORD | Optical coherence tomography, intravascular catheter | 2 | Dragonfly™ |
12 | 00812059021536 | C.0.4 Software Upgrade | 15211-01 | Software Upgrade Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | C7-XR™ |
13 | 00812059021338 | D.2 Software | C408660 | NQQ,DQO | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT),CATHETER, INTRAVASCULAR, DIAGNOSTIC | 2 | Ilumien™ | |
14 | 00812059021994 | Mobile System | C408667 | Installation Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
15 | 00812059021987 | Mobile System | C408666 | Installation Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
16 | 00812059021925 | Software Upgrade | E4-STD-WW | Software Upgrade | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
17 | 00812059021918 | Metallic Stent Optimization Software | E4-FULL-WW | Software Upgrade | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
18 | 00812059021444 | C408663 | C408663 | Tableside Controller | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
19 | 00812059021437 | Mobile System | C408662 | Upgrade Kit | NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | 2 | OPTIS™ |
20 | 00812059021420 | Mobile System | C408661 | Imaging System | 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 | 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 The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor. | 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 The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumable set consists of a Specimen Tray and Specimen Lid. The Specimen Tray engages with the device to initiate scanning and the Specimen Lid facilitates engaging vacuum to enable vacuum assisted specimen positioning during image acquisition. | 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 The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor. | 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 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 | |
47 | 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 | |
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 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 |