No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850677007167 | 4.X | PACSgear Core Server | OUG | Medical Device Data System | 1 | PACSgear Core Server | |
2 | 00850677007341 | 3X | LLZ | System, Image Processing, Radiological | GearView Basic | |||
3 | 00850677007327 | 3X | LLZ | System, Image Processing, Radiological | 2 | GearView QC | ||
4 | 00850677007112 | 5 | PACS Scan Software CD | LLZ | System, Image Processing, Radiological | 2 | PACS Scan CD | |
5 | 00850677007211 | 3.X | Mod LInk | OUG | Medical Device Data System | 1 | PACSgear Mod Link | |
6 | 00850677007280 | 3.X | LMD | System, Digital Image Communications, Radiological | 1 | PACS Scan Web | ||
7 | 00850677007037 | 1 | Dicom Box Image Acquisition Unit | LMA | Digitizer, Image, Radiological | 2 | Dicom Box | |
8 | 00850677007006 | 5 | PACS Scan Software | LLZ | System, Image Processing, Radiological | 2 | PACS Scan | |
9 | 00850677007303 | 2.X | Encounter Manager | OUG | Medical Device Data System | 1 | Image Link Encounter Workflow | |
10 | 00850677007068 | MDR Video Cart | Cart for the MDR Video | LMA | Digitizer, Image, Radiological | 2 | MDR Video Cart | |
11 | 00850677007020 | 1 | MDR Video Image Acquisition | LMA | Digitizer, Image, Radiological | 2 | MDR Video | |
12 | 00850677007297 | 3.X | OUG | Medical Device Data System | 1 | Image Link | ||
13 | 00850677007266 | 3.X | OUG | Medical Device Data System | 1 | EHR-Gateway | ||
14 | 00850677007198 | 2.X | Image Link | OUG | Medical Device Data System | 1 | PACSgear Image Link | |
15 | 00850677007150 | 2.2.X | PSM2.2.2 | PACS Scan Mobile, Android | LMD | System, Digital Image Communications, Radiological | 1 | PACS Scan Mobile |
16 | 00850677007143 | 3.0 | PSM3.0 | The PACS Scan Mobile client is an application for mobile devices that can used t The PACS Scan Mobile client is an application for mobile devices that can used to easily capture images and videos and send them to patient studies on DICOM archives. The user queries and retrieves a patient study from a worklist, or creates a new patient record. The user may then take clinical photos and/or videos to send to the patient record. Photos may be manipulated (crop and rotate) and annotated prior to sending. Videos may not be altered prior to sending. Unwanted images may be deleted prior to sending. The user may also add a series description to the study. Typical users of the PACS Scan Mobile application are trained medical professionals, including but not limited to clinicians, technologists, assistants and lay persons. PSM is not intended for diagnostic use. | FXN,LMD | Tape, Camera, Surgical,System, Digital Image Communications, Radiological | 1 | PACS Scan Mobile |
17 | 00850677007235 | 2.X | EHR Gateway | OUG | Medical Device Data System | 1 | PACSgear EHR Gateway | |
18 | 00850677007228 | 3.X | Web Forms, Mod Link Web Forms | OUG | Medical Device Data System | 1 | PACSgear Web Forms | |
19 | 00850677007310 | 2.X | OUG | Medical Device Data System | 1 | EHR-Gateway Print | ||
20 | 00850677007242 | 1.X | Media Writer Web | LMD | System, Digital Image Communications, Radiological | 1 | PACSgear Media Writer Web | |
21 | 00850677007181 | 2.X | PACS Scan Web | LMD | System, Digital Image Communications, Radiological | 1 | PACSgear PACS Scan Web | |
22 | 00850677007419 | 5.2.X | CS.5.2 | PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use. | OUG | Medical Device Data System | 1 | PACSgear Enterprise Server |
23 | 00850677007396 | 5.1.X | PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includingpatient demographics, images, videos, and HL7 messages. It also handles user accounts, security, clientconfiguration, and the flow of data between modalities and destination DICOM systems. PACSgear | OUG | Medical Device Data System | 1 | PACSgear Enterprise Server | |
24 | 00850677007389 | 1.X | Image Link Plus supports imaging workflows that do not follow the radiology work Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR). | OUG | Medical Device Data System | 1 | Image Link Plus | |
25 | 00850677007204 | 1.X | Image Link Encounter Workflow | OUG | Medical Device Data System | 1 | PACSgear Image Link Encounter Workflow | |
26 | 00850677007136 | 5 | Media Writer CD | LMD | System, Digital Image Communications, Radiological | 1 | Media Writer CD | |
27 | 00850677007082 | 2 | Video Touch 4K | LMA | Digitizer, Image, Radiological | 2 | MDR Video Touch | |
28 | 00850677007075 | MDR Video Speech | Speech for the MDR Video | LMA | Digitizer, Image, Radiological | 2 | MDR Video Speech | |
29 | 00850677007051 | 2 | Gearview QC Software | LLZ | System, Image Processing, Radiological | 2 | Gearview QC | |
30 | 00850677007273 | 4.X | Web Forms | OUG | Medical Device Data System | 1 | ModLink Web Forms | |
31 | 00850677007129 | 5 | Media Writer Software | LMD | System, Digital Image Communications, Radiological | 1 | Media Writer | |
32 | 00850677007105 | 2 | GEAR VIEW QC CD | LLZ | System, Image Processing, Radiological | 2 | GEAR VIEW QC CD |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00840241600269 | 80433-002 | 80433-002 | CareStation Server acquires and displays data from the WCD for clinicians to view. | CareStation Server | KESTRA MEDICAL TECHNOLOGIES, INC. |
2 | 00840241600252 | 80429-003 | 80429-003 | ASSURE patient app is a component of CareStation. | ASSURE Patient Application | KESTRA MEDICAL TECHNOLOGIES, INC. |
3 | 00840241600214 | 80315-005 | 80315-005 | ASSURE patient app is a component of the ASSURE WCD System and transmits informa ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation | ASSURE Patient Application | KESTRA MEDICAL TECHNOLOGIES, INC. |
4 | 00817644020178 | 6055523B1 | Genesis Touch Tab A 8.4 | MOBILEHELP, LLC | ||
5 | 00817644020161 | 6055526B1 | Genesis Touch Tab A 8.4 - RCT | MOBILEHELP, LLC | ||
6 | 00816280021068 | 106 | 106 | CorPath Imaging System | CORINDUS, INC. | |
7 | 00816280021051 | 105 | 105 | CorPath Imaging System | CORINDUS, INC. | |
8 | 00816280021044 | 104 | 104 | Powervision Imaging System | CORINDUS, INC. | |
9 | 00816280021037 | 103 | 103 | Powervision Imaging System | CORINDUS, INC. | |
10 | 00816280021020 | 102 | 102 | Powervision Imaging System | CORINDUS, INC. | |
11 | 00815098020706 | DCM-U1613 | Defibtech AirAware Remote ASI Cellular Module | DEFIBTECH, L.L.C. | ||
12 | 00812747010163 | 1.x.x | TEG Manager 1.x.x | TEG Manager | HAEMONETICS CORPORATION | |
13 | 00812747010156 | 4.x.x | TEG Manager 4.x.x | TEG Manager | HAEMONETICS CORPORATION | |
14 | 00812747010071 | 3.x.x | TEGManager version 3.x.x | TEGManager | HAEMONETICS CORPORATION | |
15 | 00811608019703 | VTELEMED | Virtual by Volk Telemedicine Software | VOLK OPTICAL INC. | ||
16 | 00811137013050 | 2.2 | 5S9804 | Fenwal DXT Relay is a Microsoft Windows-based software application intended to b Fenwal DXT Relay is a Microsoft Windows-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and computer systems. The data may also be stored in and accessed from Fenwal DXT Relay’s database | Fenwal DXT Relay | FENWAL, INC. |
17 | 00811137013043 | 5S9803 | 5S9803 | Fenwal DXT Relay is a Microsoft WINDOWS-based software application intended to b Fenwal DXT Relay is a Microsoft WINDOWS-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and Computer Systems. The data may also be stored in and accessed from Fenwal DXT Relay's database. | Fenwal DXT Relay Release 2.2 | FENWAL, INC. |
18 | 00810000890569 | WUH4060 | WUH4060 | Wireless Imaging System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
19 | 00763000609726 | TM91SCS | COMMUNICATOR TM91SCS US SCS | N/A | MEDTRONIC, INC. | |
20 | 00763000456900 | TM91SCS | COMMUNICATOR TM91SCS PAIN STIM US | N/A | MEDTRONIC, INC. | |
21 | 00763000083342 | POS12D18 | SW POS12D18 OPTIMA 1.8 GLOBAL | PACEART OPTIMA™ SYSTEM | MEDTRONIC, INC. | |
22 | 00699073708519 | 70851 | 70851 | Abbott Diabetes Care USB Data Cable Software | Abbott | ABBOTT DIABETES CARE INC |
23 | 00699073000842 | 70851 | 70851 | Abbott Diabetes Care USB Data Cable Software | Abbott | ABBOTT DIABETES CARE INC |
24 | 00643169956810 | POS12D17 | SW POS12D17 OPTIMA 1.7 GLOBAL | PACEART OPTIMA™ SYSTEM | MEDTRONIC, INC. | |
25 | 00643169956803 | POS12D17 | SW POS12D17 OPTIMA 1.7 GLOBAL | PACEART OPTIMA™ SYSTEM | MEDTRONIC, INC. | |
26 | 00643169876927 | POS12D16A | SW POS12D16A OPTIMA 1.6 WITH ANALYTICS | Paceart Optima™ System 1.6 with Analytics | MEDTRONIC, INC. | |
27 | 00643169738065 | A902 | SW APP A902 PATIENT DATA SERVICES | N/A | MEDTRONIC, INC. | |
28 | 00643169738058 | A901 | SW APP A901 COMM MANAGER | N/A | MEDTRONIC, INC. | |
29 | 00643169707351 | POS12D16 | SW POS12D16 MKT GLBL | PACEART OPTIMA™ SYSTEM | MEDTRONIC, INC. | |
30 | 00643169552296 | POS12D15 | SW POS12D15 MKT GLBL | PACEART OPTIMA™ System | MEDTRONIC, INC. | |
31 | 00643169463523 | POS12D14 | SW POS12D14 PACEART OPTIMA MKT GLBL | PACEART OPTIMA™ System | MEDTRONIC, INC. | |
32 | 00643169425545 | 8580 | CABLE 8580 DATA IR FOR 8840 WIN8 GLOBAL | N'Vision® | MEDTRONIC, INC. | |
33 | 00643169411296 | POS12D13 | SW POS12D13 PACEART OPTIMA MKT GLBL | PACEART OPTIMA™ System | MEDTRONIC, INC. | |
34 | 00643169345058 | POS12D13 | SW POS12D13 PACEART OPTIMA MKT GLBL | PACEART OPTIMA™ System | MEDTRONIC, INC. | |
35 | 00628176432229 | 00 | Innovision Display | Innovision | INNOVERE MEDICAL INC | |
36 | 00619498272068 | 27206 | 27206 | Connectivity Module (RCM) | ResMed Connectivity Module | RESMED PTY LTD |
37 | 00619498272013 | 27201 | 27201 | Connectivity Module | ResMed | RESMED PTY LTD |
38 | 00606959061132 | 00 | 1147056 | DreamStation SpO2 Connection Module | DreamStation | RESPIRONICS, INC. |
39 | 00606959058873 | 00 | 200602C | DreamStation Cellular Modem Canada | DreamStation | RESPIRONICS, INC. |
40 | 00606959058866 | 00 | 100602C | DreamStation Cellular Modem, Canada | DreamStation | RESPIRONICS, INC. |
41 | 00606959058859 | 00 | 200601C | Cellular Modem with Oximetry, Canada | DreamStation | RESPIRONICS, INC. |
42 | 00606959058842 | 00 | 100601C | DreamStation Cellular Modem with Oximetry, Canada | DreamStation | RESPIRONICS, INC. |
43 | 00606959058835 | 00 | 100625C | DreamStation Cellular Modem, Dipole, Europe | DreamStation | RESPIRONICS, INC. |
44 | 00606959058828 | 00 | 200625C | DreamStation Cellular Modem, Dipole, Europe | DreamStation | RESPIRONICS, INC. |
45 | 00606959058811 | 00 | 100624C | DreamStation Cellular Modem with Oximetry, Dipole, Europe | DS Cell wOx, Dipole, EU | RESPIRONICS, INC. |
46 | 00606959058804 | 00 | 200624C | DreamStation Cellular Modem with Oximetry, Dipole, EU | DreamStation | RESPIRONICS, INC. |
47 | 00606959058224 | 00 | 200675C | DreamStation Cellular Modem, Device, South Korea | DreamStation | RESPIRONICS, INC. |
48 | 00606959058200 | 00 | 100675C | DreamStation Cellular Modem, South Korea | DreamStation | RESPIRONICS, INC. |
49 | 00606959058187 | 00 | 100775W | DreamStation WiFi Accessory, South Korea | DreamStation Wifi Accesory, SK | RESPIRONICS, INC. |
50 | 00606959058170 | 01 | 100770W | DreamStation Cellular Modem with Oximetry, South Korea | DreamStation | RESPIRONICS, INC. |