No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00856571007258 | 10009-2 | 10009-2 | Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. | LLZ | System, Image Processing, Radiological | 2 | Archimedes Access Key, 10-pack |
2 | 00856571007241 | 10010 | 10010 | The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver c The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree when connected to a standard electrosurgical generator. The EMPOWER RF Catheter is inserted through the bronchoscope/extended working channel of 2.0 mm ID or greater to reach the target site. | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Empower RF Catheter |
3 | 00856571007074 | 10008 | 10008 | A sterile single use flexible tube with a balloon at or near the distal tip that A sterile single use flexible tube with a balloon at or near the distal tip that is inserted through the bronchoscope or sheath and used to dilate the target lung tissue of the bronchial tree. | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | Archimedes Dilation Balloon |
4 | 00856571007012 | 10005-1 | 10005-1 | Single use coring needle for retrieval of tissue samples. It is placed through Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope. | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | FleXNeedle |
5 | 00856571007296 | 10009-9 | 10009-9 | A collection of sterile devices designed to access and perform a biopsy sample d A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. w/o Syringe | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | Archimedes Access Kit |
6 | 00856571007067 | 10007 | 10007 | A sterile single use flexible tube that provides a working channel during a bron A sterile single use flexible tube that provides a working channel during a bronchoscopic procedure through which other devices may be introduced to the targeted area within the respiratory organs. The sheath is advanced through the working channel of a bronchoscope and allows for the repeated placement of endoscopic devices to a specified lesion(s) during a procedure. | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | Archimedes Sheath |
7 | 00856571007029 | 10009 | 10009 | A collection of sterile devices designed to access and perform a biopsy sample d A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | Archimedes Access Kit |
8 | 00856571007036 | 40005 | 40005 | Archimedes software is installed on a desktop computer used to plan procedures a Archimedes software is installed on a desktop computer used to plan procedures and navigate to targets in the lung. The Procedure Module offers real-time navigation guidance for use during the bronchoscopy procedure. The Software provides the option to segment previously acquired CT or other DICOM data sets and overlay and register these segmented data sets onto live fluoroscopic X-ray images. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. | LLZ | System, Image Processing, Radiological | 2 | Archimedes System |
9 | 00856571007210 | 10005-2 | 10005-2 | Single use coring needle for retrieval of tissue samples. It is placed through Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope. | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | FleXNeedle (5 pack) |
10 | 00856571007227 | 10009-1 | 10009-1 | Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. | LLZ | System, Image Processing, Radiological | 2 | Archimedes Access Key |
11 | 00856571007173 | 30005 | 30005 | LungPoint VBN Software is software installed on a desktop computer used to plan LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung. The LungPoint Procedure Program offers real-time navigation guidance for use during the bronchoscopy procedure. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. | LLZ | System, Image Processing, Radiological | 2 | LungPoint VBN System, V3.2 |
12 | 00856571007104 | 40009 | 40009 | Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue. | LLZ | System, Image Processing, Radiological | 2 | Archimedes Planning System |
13 | 00856571007234 | 12196-09 | 10009-09 | A collection of sterile devices designed to access and perform a biopsy sample d A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | Archimedies Access Kit with Syringe |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00190376470351 | AIX21000 | Vea - Mobile Alignment App | VEA | ALPHATEC SPINE, INC. | |
2 | 00066714700155 | V8 | CADI | Cadi Software | Cadi | SYNCA MARKETING INC |
3 | 00046838076619 | CCL650i2/AR | JVC | JVC KENWOOD CORPORATION | ||
4 | 00046838076602 | CCL650i2/N | JVC | JVC KENWOOD CORPORATION | ||
5 | 00046838076596 | CCL258i2/F | JVC | JVC KENWOOD CORPORATION | ||
6 | 00046838076589 | CCL258i2/AR | JVC | JVC KENWOOD CORPORATION | ||
7 | 00046838076572 | CCL258i2/N | JVC | JVC KENWOOD CORPORATION | ||
8 | 00046838076565 | MS25i2/AR | JVC | JVC KENWOOD CORPORATION | ||
9 | 00046838076558 | MS25i2/N | JVC | JVC KENWOOD CORPORATION | ||
10 | 00046838076541 | MS25i2/F | JVC | JVC KENWOOD CORPORATION | ||
11 | 00046838076534 | MS35i2/AR | JVC | JVC KENWOOD CORPORATION | ||
12 | 00046838076527 | MS35i2/N | JVC | JVC KENWOOD CORPORATION | ||
13 | 00046838076510 | MS35i2/F | JVC | JVC KENWOOD CORPORATION | ||
14 | 00046838076367 | CCL358i2/F | JVC | JVC KENWOOD CORPORATION | ||
15 | 00046838076350 | CCL358i2/N | JVC | JVC KENWOOD CORPORATION | ||
16 | B940IVZBKIT0 | ImmersiveTouch4 | ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options. | ImmersiveTouch | IMMERSIVETOUCH, INC. | |
17 | B940IMMERSIVEVIEW0 | V3.0 | The ImmersiveTouch simulators are intended as pre-operative software for simulat The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options. | ImmersiveTouch | IMMERSIVETOUCH, INC. | |
18 | B843UNISYN6110 | 6-1-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
19 | B843UNISYN5610 | 5-6-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
20 | B843UNISYN5520 | 5-5-2-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
21 | B843UNISYN5510 | 5-5-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
22 | B843UNISYN5410 | 5-4-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
23 | B843UNISYN531P20 | 5-3-1-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
24 | B843UNISYN431P10 | 4-3-1-P1 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
25 | B843UNISYN425P20 | 4-2-5-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
26 | B80731 | Breast MRI SE | 3 | QuantX is a software program that is used to view and analyze patient breast images. | QuantX | QLARITY IMAGING, LLC |
27 | B80721 | Breast MRI Biopsy Guidance Plugin | 2 | The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assi The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures. | QuantX | QLARITY IMAGING, LLC |
28 | B801THINQ1130 | 1.1.3 | THINQ | CORTICOMETRICS LLC | ||
29 | B801THINQ1000 | 1.0.0 | THINQ | CORTICOMETRICS LLC | ||
30 | B7671R522 | 5.2.2 | Rapid | Rapid System Update | Rapid | ISCHEMAVIEW, INC. |
31 | B7671R521 | 5.2.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
32 | B7671R520 | 5.2.0 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
33 | B7671R512 | 5.1.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
34 | B7671R511 | 5.1.1 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
35 | B7671R5030 | 5.0.3 | Rapid | ISCHEMAVIEW, INC. | ||
36 | B761RAPID510 | 5.1 | Rapid 5.1 | Rapid | ISCHEMAVIEW, INC. | |
37 | B761RAPID50210 | 5.0.2.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
38 | B761RAPID5020 | 5.0.2 | RAPID | ISCHEMAVIEW, INC. | ||
39 | B761RAPID5010 | 5.0.1 | RAPID | ISCHEMAVIEW, INC. | ||
40 | B761RAPID500 | 5.0 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
41 | B761RAPID49101 | 4.9.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
42 | B761RAPID48302 | 4.8.3 | RAPID | RAPID is a Platform for brain image analysis. | RAPID | ISCHEMAVIEW, INC. |
43 | B745VASCUCAPA2 | A.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
44 | B745ELUCIDVIVOA3 | A.3 | ElucidVivo | ELUCID BIOIMAGING INC. | ||
45 | B745A40 | A.1.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
46 | B725INITVV12 | 1.2 | INITVV | Visualize:Vascular is software that renders 3D images of vascular segments from Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging. | Visualize:Vascular | SALIENT IMAGING |
47 | B688IMAGEQUBE0 | ImageQube | ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication Sy ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication System (PACS), is a medical imaging information system that securely transmits, receives, and archives digitally transmitted images and provides radiologists access to patient information, medical images, annotated print pages, transcribed reports. | ImageQube | INTUITIVE IMAGING INFORMATICS, LLC | |
48 | B664CVM20 | CVM2 | Arterys Cardio DL | ARTERYS INC. | ||
49 | B664AVM30 | AVM3 | Arterys Viewer | ARTERYS INC. | ||
50 | B664AOM40 | AOM4 | Arterys Oncology DL | ARTERYS INC. |